Samsung Biologics

Samsung Biologics is an end-to-end CDMO partner of choice, providing highly tailored solutions to clients while meeting the evolving needs of the global healthcare industry.

With proven regulatory approvals, we provide seamless offerings from cell-line development to final fill/finish as well as biosafety testing at every stage for biopharmaceutical products.

Our plants are cGMP compliant holding 364KL with a wide range of bioreactor scales. To meet growing market demand, we are currently expanding capabilities with the addition of an mRNA vaccine DS manufacturing suite and construction of a new plant 4 that will hold 620KL total capacity upon completion.

www.samsungbiologics.com

Azzur Group

From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world’s leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. Follow us on LinkedIn. For more information, visit azzur.com

Cellares

Cellares is creating the future of cell therapy manufacturing and accelerating access to life-saving cell therapies. The company is developing a one-of-a-kind solution to overcome the limitations associated with manufacturing cell therapies that are more affordable and widely available to patients in need. With Cellares’ proprietary platform—the Cell Shuttle—biopharma companies, academic research centers, and CDMOs will no longer have to compromise by either choosing a manufacturing platform that is semi-automated but lacks workflow flexibility, or one that provides customization but not the end-to-end automation needed to manufacture at scale. The company is headquartered in South San Francisco, Calif.

www.cellares.com

Cytiva

Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Previously GE Healthcare Life Sciences, Cytiva’s diverse portfolio includes well-recognized brands such as ÄKTA, Amersham, Biacore, FlexFactory, HyClone, MabSelect, Whatman and Xcellerex. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients.

cytivalifesciences.com

Körber Pharma Software

Körber Pharma Software, formerly Werum IT Solutions, is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Our out-of-the-box PAS-X software is run by the majority of the worlds to 30 pharmaceutical and biotech companies and by many mid-sized manufacturers.

Our software product: Werum PAS-X MES is recognized as the world’s leading Manufacturing Execution System (MES) for the pharma, biotech and cell & gene therapy industries. We offer a full-scope MES solution comprising the PAS-X software product and pre-configured content for pharmaceutical, biotech and cell & gene processes completed by consulting, training and support services. PAS-X is a mature standard software product with full functionality that can be implemented within a comparably short time.

Körber is an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. At the Körber Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions.

www.koerber-pharma.com

MasterControl, Inc.

www.mastercontrol.com

Project Farma

Project Farma is an industry leader in providing project management, validation, engineering and consulting services with a proven track record in gene and cell therapy. We partner with gene and cell therapy organizations in addition to healthcare, pharmaceutical, bio-pharmaceutical companies to support finding ground-breaking treatments and solutions. Our gene and cell therapy clients include early stage startups, establish cell and gene therapy companies and CMOs / CROs. We are committed to helping advance cutting-edge medicines by leveraging our deep knowledge and broad experience in cell and gene therapy to meet any new challenges.

www.projectfarma.com

SmartLabs

SmartLabs provides teams of all sizes enterprise-grade labs customized within weeks for any stage of research or modality and can be reconfigured within days as your research evolves. Outsource your infrastructure and avoid the extensive costs of traditional lab builds while your own teams accelerate your research in a private lab.

www.smartlabs.com

Thermo Fisher Scientific

Thermo Fisher Scientific provides end-to-end drug development, clinical trial logistics and commercial manufacturing solutions to customers of all sizes through our Patheon brand. With more than fifty-five locations around the world, the company has extensive capabilities including drug substance and product development, viral vector services, clinical trial services and commercial-scale manufacturing.

www.thermofisher.com/patheon

Applied Materials

Applied Materials provides pharma manufacturers an opportunity to leverage decades of experience in increasing productivity. SmartFactory Rx™ is a suite of advanced manufacturing software which enables pharma companies to achieve unprecedented levels of productivity, quality and compliance from their plants and supply chain refined through 30 years of leadership based on Industry 4.0 principles. The suite is a data & application integration platform which provides: advanced process analytics & control, real-time production planning & scheduling, predictive maintenance, and knowledge advisor for creating a continuous learning environment for knowledge capture and reuse. Solutions are rapidly implemented by non-programmers using this intelligent & flexible platform to enable data-driven decisions from the shop floor to top floor.

appliedsmartfactory.com/pharmaceutical

Medidata, a Dassault Systèmes company

www.medidata.com

3M Health Care Business Group

3M solutions work to optimize your processes, applying our biopharma experience, material science and proprietary technologies to help you develop highly effective purification solutions. Our solutions are designed for upstream and downstream processing. These solutions are focused on 3M innovative technologies for the development and manufacturing of recombinant proteins including mAbs, vaccines, and therapeutic plasma proteins.

www.3m.com

Aldevron

www.aldevron.com

Basetwo Artificial Intelligence Inc

Basetwo provides a scalable AI platform that enables process engineers to rapidly build and operationalize digital twins of their manufacturing plants. From process development to commercial manufacturing, manufacturers use the digital twins they build with Basetwo AI to improve process efficiencies across the value chain.

basetwo.ai

Boehringer Ingelheim Biopharmaceuticals GmbH

Boehringer Ingelheim is a leading research-driven biopharmaceutical company and creates value through innovation in areas of high unmet medical need.

As one of the world’s largest manufacturers for biopharmaceuticals with in-depth experience in this field, the company is an industry pioneer and collaborates with top 20 pharma companies and innovative biotechs.

Boehringer Ingelheim BioXcellence™ reliably supplies innovative therapies that transform lives, today and for generations to come. We create solutions with our partners, building on our can-do attitude to improve patient health.

Our business is empowered by 5,000 dedicated and well-trained employees in development, quality and manufacturing and has access to a global manufacturing network providing the entire production chain from DNA to Fill & Finish. Our track records, both in commercial and clinical supply speak for themselves – since we started offering contract manufacturing in 1995, we have successfully brought 40 biologics to the market and have transferred and optimized more than 150 development and manufacturing projects at all stages from our customers to our facilities, as well as within our network.

While collaborating with our partners we never lose sight of the patients that depend on biopharmaceutical therapies. We offer capabilities to complement your expertise, so together we can deliver better therapies.

www.bioxcellence.com

Compliance Architects LLC

Compliance Architects LLC delivers high-value compliance, quality, and regulatory consulting services to companies directly regulated by the U.S. FDA and other global regulatory authorities. With capabilities ranging from quality systems implementations to audits, inspection readiness, enforcement remediation, and outsourced compliance services, Compliance Architects LLC has the experience, expertise, and delivery capability to significantly improve your company’s business outcomes. Jack Garvey is CA’s founder and CEO, a chemical engineer and a practicing regulatory attorney, and has spent his entire career helping companies navigate the challenges at the intersections of science, engineering, business, and law.

www.compliancearchitects.com

DCI, Inc.

DCI, Inc., founded in 1955, is a world leading manufacturer of stainless steel storage and processing vessels, agitators, and integrated systems for the food, dairy, beverage, pharmaceutical, biopharmaceutical, biotech, animal health, chemical, cosmetic, and wine industries. DCI’s portfolio of products and services includes tanks, pressure vessels, and processing equipment such as processors, fermenters, bioreactors, silos, horizontal and vertical storage tanks, aseptic media and batch tanks, mixing tanks, whey crystallizers, DCI Dynamixer, and the VARO HPT. In addition to our standard equipment, DCI also custom-engineers and builds equipment to fit your company needs and certifies your tank to meet all your ASME, ASME-BPE, PED, CE, FDA, CRN and 3A requirements.

dci-bio.com

Emerson Automation Solutions

In April 2019, Emerson acquired Bioproduction Group (Bio-G), a leader in simulation, modeling, and scheduling software for biomanufacturing. Bio-G’s scheduling and modeling systems combined with Emerson’s extensive life sciences technology and expertise portfolio will help companies bring therapies for cancer, diabetes, and other illnesses to patients sooner.

Life sciences companies continually look to accelerate the production of patient therapies and the Bio-G Scheduling software helps them accurately predict future plant resource availability to optimize manufacturing production. The scheduling software delivers an instantaneous view, accessible across an organization, into the current and future state of the plant, providing decision support to help increase facility uptime and reduce schedule-related product losses.

For more information visit www.emerson.com/rtms.

Grand River Aseptic Manufacturing

GRAM is a leading parenteral CDMO delivering customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics, small molecules, and vaccines, GRAM’s advanced technology and staff support pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.

www.grandriverasepticmfg.com

IDBS

IDBS provides cloud-based solutions to meet the unique data management challenges faced by Life Sciences teams throughout the product and process lifecycle and across the supply chain. Our innovative Polar platform is the industry’s first digital data backbone enabling customers in research, development and manufacturing to efficiently and compliantly access critical data and insights to make faster, smarter decisions with greater confidence.

IDBS serves thousands of users across hundreds of organizations around the globe, including 23 of the top 25 pharmaceutical companies and more than 250 small and medium-sized pharma and biopharma companies, CROs, CDMOs, and CMOs.

www.idbs.com

Levitronix Technologies Inc.

Levitronix offers single-use and multi-use pumps with a low shear design for sensitive fluids like cells, LNP’s and proteins for the Biotech Industry, perfectly suited for Biologics and Gene Therapy. The product range enables full manufacturing scalability up to flow rates of 140 L/min and beyond.

Levitronix also offers high precision single-use flow sensors and non-invasive clamp-on flow sensors as well as flow and pressure control systems.

www.levitronix.com

MaxCyte

MaxCyte® is a leading provider of cell-engineering platform technologies and is responsible for helping to bring next‐generation cell-based therapies to life. The Company’s technology is employed by leading drug developers worldwide, including 20 of the top 25 global biopharmaceutical companies. Our Flow Electroporation® technology and next-generation ExPERTTM platform enable our partners to accelerate, streamline, and improve the drug development process from the early stages of research to commercialization. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, U.S.

maxcyte.com

QbDVision, Inc.

QbDVision is an innovative software company pioneering the development of modern digital solutions for the pharma/biotech industry to accelerate the manufacturing development cycle, increase the probability of technical success, and help get therapeutic breakthroughs to patients that much faster.

For many of the newest therapies being developed, the associated manufacturing processes are complex and the next generation of software solutions need to move the industry away from document-centric and spreadsheet-centric information management. QbDVision has assembled a group of industry veterans with 100+ years of collective experience in process development, tech transfer, pharmaceutical quality, and regulatory compliance to develop the next generation of structured data solutions that will dramatically increase R&D efficiency.

www.qbdvision.com

Resilience US

Resilience is a technology-focused manufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company aims to build a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives.

resilience.com

Scorpius BioManufacturing

Scorpius BioManufacturing is an integrated contract research and contract development & manufacturing organization (CDMO) focused on rapidly advancing your mammalian and microbial biologic programs to the clinic and beyond. With end-to-end capabilities from discovery to limited-scale commercial production, we provide a broad array of R&D, analytical testing, and manufacturing services to pharmaceutical and biotech companies. With an experienced team and new, purpose-built, U.S. facilities, Scorpius is dedicated to easily accessible, transparent collaboration and flexible biologics biomanufacturing.

www.scorpiusbiologics.com.

Sharp Services

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services. For 70 years, we’ve provided solutions to pharma and biotech clients from phase I trials through to commercial launch and lifecycle management. With facilities in the United States, United Kingdom, Belgium and the Netherlands and 30+ clinical depots globally, covering every region of the world, we are engineered to deliver.

Through our partnership with Berkshire Sterile Manufacturing we offer specialist isolator-based filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization.

Learn more at www.sharpservices.com

Temptime Corporation - A Zebra Technologies Company

Temptime is the world leader in development and manufacture of time-temperature indicators that protect patients by alerting the user that a medical product has been exposed to potentially damaging temperatures. We perform a vital role in the delivery of global healthcare by providing manufacturers and distributors with heat and freeze indicators that monitor medical products. Our extensive range of time-temperature indicators change color to signal the occurrence of a potentially damaging heat or freeze event, allowing the user to determine whether or not the product should be used in the treatment patients. The indicators can be affixed to an individual unit to follow the product from manufacture to use, inserted into the secondary packaging to monitor multiple units of the product, or into shipping boxes to monitor the shipping carton during a shipping segment.

temptimecorp.com

ValGenesis, Inc.

ValGenesis is the pioneer of paperless validation, and the inventor of the ValGenesis VLMS, the industry’s first, proven, 100% paperless validation lifecycle management solution, trusted by hundreds of life science customers as a system of record for validation. Covering the entire lifecycle process, ValGenesis VLMS delivers technology solutions that are validated, fully configurable and rapidly deployable through a validated private secured Cloud. ValGenesis VLMS enables new levels of collaboration, data integrity, risk management, and compliance with validation lifecycle management processes.

www.valgenesis.com

Tower Cold Chain

Tower delivers proven physical and temperature protection for pharmaceutical and life science products and our robust, reliable, and reusable containers are the essential link in the stability of the cold chain.

We operate a global network ensuring availability and easy access to our products for all customers across the US, Europe, Asia-Pacific and South Africa.

For over a decade Tower Cold Chain leads the way with its innovative solutions for the reusable controlled-temperature market. Currently servicing and supplying 30 of the world’s top pharma and pharma 3PL companies.

We are trusted by global pharmaceutical, logistics and airline companies and our experienced team, supported by a centralized quality-management system, reinforces customer confidence that our shipping facilities will meet requirements throughout the supply chain. Our patented design technology ensures our solutions meet the pharmaceutical industry performance standard, providing a minimum of 120 hours temperature compliance in any environment, anywhere in the world.

TOWERcoldchain.com

Veeva Systems Inc.

Veeva is the global leader in cloud software for the life sciences industry with a keen focus on quality manufacturing. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs, CDMOs, and contract services. Veeva powers organizations to manage end-to-end quality processes in one easy to use unified cloud solution to drive speed, collaboration, and compliance.

As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.

See how Veeva can help you modernize quality manufacturing at veeva.com/qualitymanufacturing

AbbVie Inc.

Vision. Expertise. Success.

AbbVie Contract Manufacturing partners with companies across the globe to develop, scale and manufacture pharmaceutical products and bring them successfully to market.

Drawing on more than four decades of success as the manufacturing division of AbbVie, we have the depth of experience and the technical knowledge to navigate issues and deliver the innovative solutions customers need. We are much more than a CMO – we are your partner for success.

With foresight, scientific expertise and passion we anticipate the technical and compliance challenges along the entire pharmaceutical development journey through to commercialization. We see the complete picture to deliver our customer’s vision.

With full access to global state-of the-art facilities and world-class talent, our customers have come to depend on our service and quality to deliver real-world results.

www.abbviecontractmfg.com

Alcami Corporation

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging 675,000 ft² across five US-based scientific campuses, Alcami serves pharmaceutical and biotech companies of all sizes providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami’s private equity ownership includes Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit alcaminow.com and masy.com

Apprentice

www.apprentice.io

Aventior, Inc.

Aventior is a one of leading technology firms focused on developing automation and AI based platforms for the life sciences and biotech industries. It’s CPV-Auto platform automates the process of digitizing paper batch records. The CPV-Auto platform is GxP compliant and is ideal for supporting biomanufacturing processes, specifically well suited for cell and gene therapy production facilities (in-house and CMOs). The platform reduces the digitization time by over 300% and decreases the total cost of ownership by over 75%. Outside of batch records, the platform has also been used to digitize COA files, pre-clinical records, shipping data, product specifications and other documents. It can integrate with some of the leadings PIMS and MES platforms.

www.aventior.com

Be The Match BioTherapies

Be The Match BioTherapies® partners with cell and gene therapy companies to save lives through autologous and allogeneic cellular therapy. We are the only cell and gene therapy solutions provider with customizable services to support the entire end-to-end cell therapy supply chain. As part of the National Marrow Donor Program®(NMDP)/Be The Match®, Be The Match BioTherapies has sourced, collected and delivered cells from more than 100,000 volunteer allogeneic donors around the world for time-critical cellular therapies. We have extensive experience providing cellular source material consented for research, clinical and commercial use. Throughout the past 35+ years, Be The Match BioTherapies has developed and continually enhanced their cell collection network and proven cell therapy supply chain infrastructure. The teams are responsible for more than 6,500 time-sensitive cell therapy shipments per year. Through the CIBMTR® (Center for International Blood and Marrow Transplant Research®), Be The Match BioTherapies provides long-term follow-up tracking for the first two FDA-approved CAR-T therapies.

bethematchbiotherapies.com

Binocs

BINOCS is a global provider of AI/ML based orchestrated scheduling and forecast planning needs and has been specifically designed to address the challenges in Cell & Gene therapy industry. BINOCS can assist therapy developers in efficiently manage internal and external resources to create a great customer (HCPs) and patient experience by providing real-time updates and information on the development of individual therapeutics. BINOCS is already supporting commercial CAR-T and many other late & early stage clinical studies.

discover-binocs.com

CAI

Since our founding in 1996, CAI strives to help our clients design, deliver, operate, and maintain quality, critical manufacturing facilities by pooling our global resources of 800+ employee-owners. Our engineering, technical, and consulting services encompass all aspects of operation. We integrate people, process, equipment, systems, and facilities into a high-performance manufacturing operation. The result is a superior level of operational performance and reliability. With offices in the Americas, Ireland, the UK, Italy, Switzerland, China, India, Singapore, Korea, and Australia, we have been able to serve the needs of clients all over the world. CAI is involved in each part of the project when you need to meet a higher standard.

Our service offerings have evolved out of the needs of the customer for 25 years. Every service offering is considered a Business Area. A business area consists of a set of services that requires a unique quality system, a set of personnel with skills and experience, and a potentially unique client base. A business area requires unique knowledge of and approaches to a market segment. Within a business area there may be multiple areas of technical focus; these focus areas are mutually supportive of the business area but are not distinct business areas themselves. CAI serves clients in the following business areas:

• Commissioning & Qualification
• Building Commissioning
• Asset Management & Reliability
• Quality, Regulatory, & Compliance
• Human Performance
• Process & Manufacturing Technology
• Program & Project Management
• Automation & Information Technology

cagents.com

Camfil

The world leader in clean air technology and air filter production, Camfil is the foremost supplier of air filtration, terminal and containment housings to the Life Science industries.

We provide the tools to achieve sustainability, maintain high air quality and reduce airborne contaminants, while lowering total cost of ownership.

camfil.com

Dot Compliance

Dot Compliance offers the industry’s first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance Suite includes an extensive set of off-the-shelf ready quality and compliance pre-configured processes, enabling customers to deploy quickly and cost-effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages and are fully compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14791, and 27001.

Eliminating costly customization and professional service fees, Dot Compliance ready to use solutions allow life science organizations to quickly deploy and manage processes such as Controlled Documents, Training Management, CAPA, Customer Complaints, Audits, Supplier Quality, Risk Management, Equipment and Maintenance, BOM and more.

Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to easily deploy flexible and scalable solutions.

For more information, check us out at www.dotcompliance.com

INCOG BioPharma Services, Inc.

We’re a new standard of CDMO.

Designed to deliver better.

Better solutions for your drug product.

From development through commercialization.

Better experiences, designed around you.

At INCOG, we are striving for better, creating a new standard of CDMO that considers the customer’s experience from initial discussion through final packaged product delivered to patients.

Better outcomes delivered with you, for you.

The drug development journey is not simple. When working with a CDMO, you need absolute certainty that your partner understands your needs, your critical milestones and your timelines. Every decision we make about your product will be made with you, for the success of your project.

Better solutions for your drug product.

We are proud to manufacture for the future of medicine. With world-class facilities, state-of-the-art equipment and some of the industry’s most talented people, you can feel confident that your drug product is in safe hands.

www.incogbiopharma.com

International Space Station National Laboratory

www.issnationallab.org

Lonza Group Ltd

At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome, at the time when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges. Together, we can bring your next medicine to life.

www.pharma.lonza.com

Porton Advanced

Porton Advanced Solutions (Porton Advanced) is a Cell and Gene Therapy (CGT) CDMO. We provide end-to-end process development (PD), analytical development (AD), GMP manufacturing, and testing services to meet clients’ therapeutic product needs at pre-clinical, clinical, and commercial stages.

Our dedicated process and analytical development teams have established robust platform-based USP/DSP and GMP manufacturing capability and capacity, as well as proprietary technologies to further empower our clients’ successes.

Our services include gene and cell engineering discovery research and technology licensing, process development and analytical development, testing, drug substances (DS) and drug products (DP), and cGMP manufacturing across plasmids, cell therapy, gene therapy, virotherapy, and mRNA-based therapeutic platforms.

www.portonbio.com

PQE US Inc.

PQE is a complete quality solutions provider (30 offices globally, 1500+ consultants).

In its 20+ years of life, PQE has worked with thousands of clients and always applied the latest technologies and discoveries to help companies achieving their full potential. As an innovation-based agency, we are constantly developing new services and updating our areas of expertise.

www.pqegroup.com

ProPharma Group

ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

www.ProPharmaGroup.com

Repligen

Inspiring advances in bioprocessing, Repligen is a technology leader in filtration, chromatography, systems, process analytics and Protein A ligand development for bioprocessing and gene therapy. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help address critical steps in the production of therapeutics, vaccines and diagnostics worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Boston, MA with major manufacturing sites in Massachusetts, California, New Jersey, Sweden, and Germany.

www.repligen.com

Rousselet-Robatel Inc.

www.rr-centrifuge.com

Singota Solutions

Singota Solutions is a Contract Development and Manufacturing Organization focused on getting products to patients faster by being agile, accountable, and transparent. Our aseptic filling service features a completely gloveless, robotic workcell which provides a highly repeatable and precisely controlled process for filling injectable products into vial, syringe, and cartridge formats. This enhances our ability to manufacture smaller batch sizes and minimize line loss. We also provide customized solutions for formulation development, supply chain & materials management, analytical testing, and labeling & kitting services.

singota.com

Wheeler Bio, Inc

wheelerbio.com

Yposkesi, an SK Pharmteco Company

Yposkesi, an SK pharmteco company, is one of Europe’s largest CDMO for gene therapy viral vector manufacturing.

A one-stop shop for biotech and pharmaceutical companies seeking to advance clinical trials and commercialize new ATMPs, Yposkesi offers a full range of services in lentiviral vectors and AAV cGMP manufacturing. Within its current 50,000 ft2 (approx. 5,000 m2) facility, Yposkesi operates multiple manufacturing suites for bulk drug substance (up to 1,000 L) and fill and finish to support the growing demand for late-phase projects. In 2023, Yposkesi will bring online additional capacity by increasing its global footprint to 100,000 ft2 (approx. 10,000 m2) with a second large-scale facility designed for EMA and FDA compliance.

Yposkesi’s investment in innovation ensures that its bioprocessing platforms deliver high quality gene-modified cell therapies and in vivo gene therapy projects.

Yposkesi’s staff of ~200 employees is located on the Genopole Campus in Corbeil-Essonnes (South of Paris), France.

www.yposkesi.com

AGC Biologics

AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial production, using mammalian and microbial production systems.

Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression — including our proprietary CHEF1® Expression System for efficient protein production with CHO cells.

Our company DNA drives us to provide innovative solutions for clients to reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle.

We forge exceptionally strong partnerships with our clients and we never lose sight of our commitment to deliver reliable and compliant drug substance. Right. On Time.

OUR MISSION
To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

OUR VISION
To be the first provider that customers call when they are looking for a Contract Development Manufacturing Organization.

OUR VALUES
Innovation & Operational Excellence
Diversity
Protect the Environment
Integrity

www.agcbio.com

Andelyn Biosciences

Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions that turn hope into reality as a cell and gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing, full quality system/regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 16+ production suites for customization of new programs and tech transferred programs as of September 2022, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Gene and cell therapy, AAV viral vector manufacturing, Plasmid Manufacturing, Lentiviral vector Manufacturing, Commercial Manufacturing, CDMO, analytical method development, GMP, fill finish, QC/QA release testing, Process Characterization, Regulatory Affairs, Licensing

Azzur Group

From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world’s leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. Follow us on LinkedIn. For more information, visit azzur.com

Bionova Scientific LLC

Bionova Scientific is a rapidly growing biologics CDMO offering world-class services built on a foundation of strong process development and analytical science. Our team shares decades of experience in late stage and commercial launch projects, specializing in mammalian cell culture production of mAbs, bispecifics, fusion proteins and other recombinant proteins.

We recently launched a new commercial-ready GMP biologics manufacturing facility and are on-track to complete our first clinical supply run before year-end. With several additional runs already signed, we are currently booking slots for 2022.

We firmly believe that a robust, well-understood process and well-characterized molecule are critical cornerstones of your molecule’s success. Our upstream PD group, with more than 60 benchtop bioreactors, offers capabilities typically found in CDMOs five times our size.

www.bionovascientific.com

Boehringer Ingelheim Biopharmaceuticals GmbH

Boehringer Ingelheim is a leading research-driven biopharmaceutical company and creates value through innovation in areas of high unmet medical need.

As one of the world’s largest manufacturers for biopharmaceuticals with in-depth experience in this field, the company is an industry pioneer and collaborates with top 20 pharma companies and innovative biotechs.

Boehringer Ingelheim BioXcellence™ reliably supplies innovative therapies that transform lives, today and for generations to come. We create solutions with our partners, building on our can-do attitude to improve patient health.

Our business is empowered by 5,000 dedicated and well-trained employees in development, quality and manufacturing and has access to a global manufacturing network providing the entire production chain from DNA to Fill & Finish. Our track records, both in commercial and clinical supply speak for themselves – since we started offering contract manufacturing in 1995, we have successfully brought 40 biologics to the market and have transferred and optimized more than 150 development and manufacturing projects at all stages from our customers to our facilities, as well as within our network.

While collaborating with our partners we never lose sight of the patients that depend on biopharmaceutical therapies. We offer capabilities to complement your expertise, so together we can deliver better therapies.

www.bioxcellence.com

Center for Breakthrough Medicine

Center for Breakthrough Medicines (CBM) is an Advanced Therapy CDMO dedicated to addressing the challenges with bringing breakthrough therapies to patients. CBM offers pre-clinical through commercial manufacturing capabilities spanning process development; plasmid DNA, viral vector, and cell therapy production; and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

Compliance Architects LLC

Compliance Architects LLC delivers high-value compliance, quality, and regulatory consulting services to companies directly regulated by the U.S. FDA and other global regulatory authorities. With capabilities ranging from quality systems implementations to audits, inspection readiness, enforcement remediation, and outsourced compliance services, Compliance Architects LLC has the experience, expertise, and delivery capability to significantly improve your company’s business outcomes. Jack Garvey is CA’s founder and CEO, a chemical engineer and a practicing regulatory attorney, and has spent his entire career helping companies navigate the challenges at the intersections of science, engineering, business, and law.

www.compliancearchitects.com

CSafe

CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world. With a “patient-first” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products in both the active and passive segments. CSafe is the only provider with an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases allowing our team to match your requirements to the best solution for your needs. Any size, any duration and any temperature – CSafe is At the Heart of Your Cold Chain.

csafeglobal.com

DynamixE, Inc.

DynamixE is an engineering and technology firm focused on Biologics, Cell & Gene Therapy BioManufacturing Facilities.  Our  mission is to change how Biotechnology GMP Capex projects are delivered by leveraging an exceptionally high standard of technical expertise; a set of highly studied and integrated workflows; and built upon a digital cloud platform that drives certainty of delivery.  DynamixE’s core focus areas are in process engineering, automation/digital GMP, and start up/CQV deployed across the US and Canada.  Our mode of operation is to remove obstacles to meet business drivers.

www.dynamixe.com

Fluor

Fluor is building a better future by applying world-class expertise to solve its clients’ greatest challenges. Fluor’s 41,000 employees provide professional and technical solutions that deliver safe, well-executed, capital-efficient projects to clients around the world. For decades, Fluor has designed and built various types of biotech and bulk pharmaceutical facilities, employing batch, semi continuous, and continuous operations. We offer the life sciences industry agility and robustness through expertise in process design while providing innovative professional and technical solutions.

www.fluor.com

Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility focused on AAV manufacturing and can host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

www.forgebiologics.com

Fujifilm Diosynth Biotechnologies

www.fujifilmdiosynth.com

IDA Ireland

IDA Ireland was founded in 1949 as the Irish Government agency responsible for the attraction and retention of foreign direct investment (FDI) into Ireland. IDA Ireland partners with multinational companies to attract investment, providing jobs for the economic and social benefit of Ireland.
We have partnered with 1,200 companies to establish operations in Ireland, including all the World’s Top 10 Biopharmaceutical companies.
The biopharmaceutical industry has made a capital investment of approximately $10 billion in new facilities in Ireland, most of which has come in the last 10 years. This represents the biggest wave of investment in new biotech facilities anywhere in the world.
Speak with us and you will soon understand why Ireland has developed Europe’s premier biopharma manufacturing cluster.

www.idaireland.com

ILC Dover LP

ILC Dover is a world-leader in the innovative design and production of engineered flexible solutions. Based in Newark, Delaware, we serve the pharmaceutical industry with single-use flexible powder solutions that facilitate safe and reliable performance and productivity in the lab. CMOs and CDMOs choose our solutions for powder transfers and containment over rigid stainless-steel systems, for the significant advantages they bring to chemical synthesis of HPAPI and OSD processing for final drug products.

www.ilcdover.com

Just – Evotec Biologics

Just – Evotec Biologics is a first-to-industry biologics platform company that applies deep industry expertise, AI/ML technologies and world-leading molecular design, cell line development, process intensification and advanced continuous manufacturing strategies to expand access to biotherapeutics.

Just – Evotec Biologics offers drug developers a powerful, integrated approach to biotherapeutic development – from target to market – with a collaborative partnering culture.

just-evotecbiologics

KYNOTA

KYNOTA is an open bioprocess data integration solution accelerating time to market with real-time contextualized data, allowing for a focus on science improving both productivity and throughput. When developing a cell therapy, gene therapy, or other advanced therapeutic medicinal product (ATMP) the dynamics of the industry make it essential to reduce inefficiencies & optimize processes leading to increased speed to market. With KYNOTA, a subscription-based, turnkey bioreactor software solution, you can integrate all devices regardless of manufacturer, unify and contextualize data, optimize workflows, gain control in real time, reduce errors, and smoothly prepare for tech transfer.

www.kynota.com

McCord

McCord, a Houston-based real estate firm with an office in Boston, has a long history of producing significant value through the purchase, development, and management of office, life science, industrial, land, single family, and multifamily properties. McCord has owned and managed nearly $3 billion in real estate across the United States since 1973, including 4.8 million square feet of commercial space, 6,700 residential units, and 6,000 acres of land.

McCord’s legacy project, Generation Park (www.GenerationPark.com), a 4,300-acre master-planned commercial development in Houston, Texas, is strategically located to benefit bioscience manufacturing and development companies. The proximity to the largest patient population in the world (Texas Medical Center), two international airports, the Port of Houston, and colleges with biopharma workforce training programs within the development make Generation Park an ideal location for the sciences to take root and scale.

McCord is proud of the strong relationships forged with its tenant partners and takes very seriously its role in providing exceptional work environments that help attract and retain top talent.

At McCord, our mission is to enable yours.

www.generationpark.com

ParkourSC

ParkourSC delivers agility and transparency in supply chain operations for pharmaceutical, life sciences, and biologics companies, to drive strategic innovation and resilience, enable timely decisions, narrow demand and supply variances, and increase revenue.

Our digital supply chain operations platform improves patient outcomes by ensuring compliance, quality, and timely delivery of sensitive therapies. The platform provides a “command center” to predict at-risk situations in the supply chain by monitoring the performance of every entity, flagging quality and compliance risks, automating workflows across organizations, fostering collaboration to resolve issues and prevent waste, and to bridge the gap in planning and execution cycles by automatically delivering real-time updates to planners.

www.parkoursc.com

QIAGEN

QIAGEN pushes the boundaries of innovation to improve our understanding of DNA, RNA and proteins – the building blocks of life. We enable our customers to unlock valuable insights from any biological sample – be it blood, a throat swab or many other materials. We support their success with a broad range of products for molecular testing, serving applications from basic life sciences research to clinical healthcare. Never before have QIAGEN’s molecular testing solutions made a stronger impact on people’s lives than in the global fight against COVID-19. It is one of the many ways we are¬ advancing science and improving outcomes for people across the world. We are known for highest quality products and outstanding service from a global organization of 6.000 passionate people in 35 countries. Our reputation is based on confidence in decisions, clarity of results and pride in the insights our customers achieve. More than 35 Nobel Prize winners among more than 500,000 customers worldwide are proof of that success. We will continue to define the advancements of tomorrow – in line with our vision of making improvements in life possible.

Discover more at http://www.qiagen.com.

Samsung Biologics

Samsung Biologics is an end-to-end CDMO partner of choice, providing highly tailored solutions to clients while meeting the evolving needs of the global healthcare industry.

With proven regulatory approvals, we provide seamless offerings from cell-line development to final fill/finish as well as biosafety testing at every stage for biopharmaceutical products.

Our plants are cGMP compliant holding 364KL with a wide range of bioreactor scales. To meet growing market demand, we are currently expanding capabilities with the addition of an mRNA vaccine DS manufacturing suite and construction of a new plant 4 that will hold 620KL total capacity upon completion.

www.samsungbiologics.com

Samsung Biologics

Samsung Biologics is an end-to-end CDMO partner of choice, providing highly tailored solutions to clients while meeting the evolving needs of the global healthcare industry.

With proven regulatory approvals, we provide seamless offerings from cell-line development to final fill/finish as well as biosafety testing at every stage for biopharmaceutical products.

Our plants are cGMP compliant holding 364KL with a wide range of bioreactor scales. To meet growing market demand, we are currently expanding capabilities with the addition of an mRNA vaccine DS manufacturing suite and construction of a new plant 4 that will hold 620KL total capacity upon completion.

www.samsungbiologics.com