Samsung Biologics

Samsung Biologics is a fully integrated CDMO partner providing highly tailored solutions to each client. Our end-to-end services include upstream and downstream process development, clinical and commercial manufacturing, aseptic fill/finish, and analytical and biosafety testing—all from a single location. Our plants are cGMP compliant holding 364KL total capacity with wide range of 1KL, 5KL, 15KL scale bioreactors. To meet the growing market demand, we are currently expanding manufacturing capacity with the new plant 4 with additional 264KL.

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

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

BIOVIA

BIOVIA solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live. The industry-leading BIOVIA portfolio integrates the diversity of science, experimental processes and information requirements, end-to-end, across research, development, QA/QC and manufacturing. Capabilities include Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics. BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries. BIOVIA and Medidata belong to the Dassault Systèmes family of companies.

www.medidata.com/en/biovia-manufacturing-analysis

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

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

Basetwo Artificial Intelligence Inc

basetwo.ai

Boehringer Ingelheim Biopharmaceuticals GmbH

In sharing with the corporate values and beliefs, Boehringer Ingelheim BioXcellence™ is organized as its own stand-alone business unit, empowered by its’ innovative and motivated individuals. With over 35 years of biotechnology experience, the combination of our more than 3,600 dedicated and expertly trained employees in development, quality and manufacturing along with a global network of locations, we are capable of providing the entire production chain from DNA to Fill & Finish. Our track record of accomplishment speaks for itself: Since our inception of offering contract manufacturing in 1995, we have successfully brought more than 30 biologics to the market.

Working with 15 of the world’s Top 20 Pharma and many innovative biotech companies, we never lose sight of the patients that depend on these breakthrough 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. For additional information, visit www.dciinc.com

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

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

Resilience

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

SmartLabs

www.smartlabs.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

TIBCO Software Inc.

TIBCO Software Inc. unlocks the potential of real-time data for making faster, smarter decisions. Our Connected Intelligence platform seamlessly connects any application or data source; intelligently unifies data for greater access, trust, and control; and confidently predicts outcomes in real time and at scale. Learn how solutions to our customers’ most critical business challenges are made possible by TIBCO at www.tibco.com.

Tower Cold Chain

TOWER Cold Chain Solutions’ passive KryoTrans® thermal containers provide a solution to reduce the total cost of shipping. TOWER provides a developing global infrastructure with full-service centres across the US, Europe, Asia-Pacific & South Africa creating a flexible service.

For over a decade TOWER has led 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: these players trust TOWER containers and the simplicity and reliability they bring.

With zero-temperature-excursion phase-change technology TOWER containers are simple to store, load, ship, unpack and store.

TOWERcoldchain.com

ValGenesis, Inc.

ValGenesis, Inc. is the creator of the industry’s leading Validation Lifecycle Management System (VLMS). This innovative platform handles the entire corporate validation lifecycle and is used by 30 of the top 50 global life science companies. ValGenesis was the first entirely paperless electronic solution for managing validation and remains the most complete solution on the market, covering computer system validation, computer software assurance, electronic logbook, reliability traceability matrix, process, method, and more. Customers specifically cite significant increases in teamwork and process efficiency, reduction in errors and strengthened data integrity, standardization of procedures, and 50% cost reductions in validation programs.

www.valgenesis.com

Veeva Systems Inc.

Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 775 customers, ranging from the world’s largest pharmaceutical companies to emerging
biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America.

www.veeva.com

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

Aizon

Aizon is an AI software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production and quality within highly regulated industries. The Aizon platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Aizon offers an intuitive way to gain meaningful operational intelligence by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity.

www.aizon.ai

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

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

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.

Honeywell Process Solutions

www.honeywellprocess.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

Russell Reynolds Associates

Russell Reynolds Associates is a global search and leadership advisory firm. Our 425+ consultants in 46 offices work with public, private and nonprofit organizations across all industries and regions. We help our clients build teams of transformational leaders who can meet today’s challenges and anticipate the digital, economic and political trends that are reshaping the global business environment. From helping boards with their structure, culture and effectiveness to identifying, assessing and defining the best leadership for organizations – our teams bring their decades of expertise to help clients solve their most complex leadership issues.

www.russellreynolds.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 four US-based scientific campuses, Alcami serves biologics and pharmaceutical companies of all sizes providing customizable and innovative solutions for development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology and analytical services. Alcami’s private equity owners include Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit alcaminow.com, mdcp.com, or ampersandcapital.com.

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

bethematchbiotherapies.com

BINOCS

discover-binocs.com

CAI

cagents.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

Porton Advanced

www.portonbio.com

PQE US Inc.

Founded in 1998, PQE Group is a consulting company in the pharmaceutical field that has its Headquarter in Reggello (Florence, Italy) and since 2012 has opened 26 offices worldwide, developing a network of contacts at international level.

Certified ISO 9001 since March 2003, PQE has been characterized as Complete Quality Solutions Provider for companies operating in the Life Science field, both nationally and internationally. It currently has more than 900 employees distributed in the operational offices in Italy, Germany, Spain, France, Switzerland, UK, Belgium, Poland, Russia, Israel, USA, Mexico, Brazil, Argentina, India, China and Japan.

As an international workforce, the consultants at PQE Group have experience in working in over 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities.

PQE Group offers turnkey quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.

Combining the high knowledge acquired in the fields of Processes, Information Technology, Engineering and Quality, PQE Group supports its clients in both Pharmaceutical and Medical Device fields in the following areas:

• Data Integrity Assurance
• Computer System Validation
• Digital Governance
• Qualification of laboratory process equipment and utilities
• GxP Compliance
• Laboratory Excellence
• Regulatory Affairs & Pharmacovigilance
• Qualification & Engineering
• Auditing
• Training

www.pqegroup.com

ProPharma Group

ProPharma Group is the truly global, independent, single-source provider of regulatory, compliance, pharmacovigilance, and medical information services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory and compliance solutions 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

QIAGEN

www.qiagen.com

QbDVision, Inc.

CherryCircle 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. CherryCircle 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

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

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

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

Andelyn Bio Sciences

andelynbio.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

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

In sharing with the corporate values and beliefs, Boehringer Ingelheim BioXcellence™ is organized as its own stand-alone business unit, empowered by its’ innovative and motivated individuals. With over 35 years of biotechnology experience, the combination of our more than 3,600 dedicated and expertly trained employees in development, quality and manufacturing along with a global network of locations, we are capable of providing the entire production chain from DNA to Fill & Finish. Our track record of accomplishment speaks for itself: Since our inception of offering contract manufacturing in 1995, we have successfully brought more than 30 biologics to the market.

Working with 15 of the world’s Top 20 Pharma and many innovative biotech companies, we never lose sight of the patients that depend on these breakthrough therapies.

www.bioxcellence.com

Cellares

www.cellares.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

The urbanizing world needs reliable infrastructure, advanced technologies, life science innovations, ample resources, and sophisticated manufacturing. Fluor supports these industries with proven engineering, procurement, construction (EPC) services and professional staffing services.

www.fluor.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.

Partner with us and you will soon understand why Ireland wins for ease of doing business.

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

Samsung Biologics

Samsung Biologics is a fully integrated CDMO partner providing highly tailored solutions to each client. Our end-to-end services include upstream and downstream process development, clinical and commercial manufacturing, aseptic fill/finish, and analytical and biosafety testing—all from a single location. Our plants are cGMP compliant holding 364KL total capacity with wide range of 1KL, 5KL, 15KL scale bioreactors. To meet the growing market demand, we are currently expanding manufacturing capacity with the new plant 4 with additional 264KL.

www.samsungbiologics.com

Samsung Biologics

Samsung Biologics is a fully integrated CDMO partner providing highly tailored solutions to each client. Our end-to-end services include upstream and downstream process development, clinical and commercial manufacturing, aseptic fill/finish, and analytical and biosafety testing—all from a single location. Our plants are cGMP compliant holding 364KL total capacity with wide range of 1KL, 5KL, 15KL scale bioreactors. To meet the growing market demand, we are currently expanding manufacturing capacity with the new plant 4 with additional 264KL.

www.samsungbiologics.com

Sharp Services

www.sharpservices.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

QbDVision, Inc.

CherryCircle 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. CherryCircle 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