Accenture

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions—underpinned by the world’s largest delivery network—Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 482,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

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.

http://www.appliedmaterials.com/automation-software/products/pharma

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 Cleanrooms on Demand™

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

Medidata, a Dassault Systèmes Company

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.

medidata.com

AbbVie

AbbVie Contract Manufacturing has been serving our partners for more than 35 years across ten of our manufacturing facilities located in both North America and Europe. Our contract development and manufacturing capabilities span both small and large molecule API including classical fermentation, chemical synthesis and biologics. In addition to APIs, we are offering extensive experience and technical solutions in the area of drug product manufacturing which includes traditional tablet and capsule production with emphasis on DEA controlled drugs, potent, ADCs and hot melt extrusion. Lastly, we can also package your product regionally and also offer prefilled syringe manufacturing capabilities.

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

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

Camfil Clean Air Solutions

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.

www.camfil.com

Cognate Bioservices Inc.

Cognate BioServices is a leading contract development and manufacturing organization specialized in cell and cell-mediated gene therapies, DNA/Plasmid and Viral vectors with the acquisition of Cobra Biologics in the UK and Sweden earlier this year. We pride ourselves in the level of quality and experience logistics support we bring to the table with both companies being commercial ready to supply expertise and capacity from the ground up. We are unique in a number of ways, including but not limited to:

Our late stage experience in personalized cellular therapies and complex biologics and pharmaceuticals for over 20 years in multiple geographies;
A wide range of operating, technical and leadership experience spanning cellular immunotherapy and regenerative medicine and biotechnology;
A commitment to commercial readiness and PAI inspection for personalized and off-the-shelf cellular immunotherapy products including but not limited to, Car-t, TCR, TIL, MIL, DC, and NK cells as well as the development and manufacture of drugs.

In our operating history we’ve successfully manufactured and delivered products to and from the US, EU and Asia, and we’ve handled all aspects of the supply chain, manufacturing, storage, shipping and clinical trial logistics, fill/finish and regulatory support for protocol and IND development for complex products involving multiple drug substance intermediates all the way to minimally manipulated primary cells and intermediates used to support cells therapies at Cobra Biologics

www.cognatebioservices.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

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

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

Lonza

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

Rapid Micro Biosystems

www.rapidmicrobio.com

Skyland Analytics

Founded in 2015 and headquartered in Boulder, Colorado, Skyland’s core team has worked together for over 20 years and has deep expertise in life science manufacturing, IT systems, data analytics, validation and product quality. Having developed the ‘first generation’ product-process data information solution, the team has applied this experience to deliver a ‘next generation’ platform that leverages cloud-based technology to deliver better, faster solutions with a much lower total cost of ownership.

skylandanalytics.net

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

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

Just - Evotec Biologics

Designing and applying innovative technologies to dramatically expand global access to biotherapeutics

Just – Evotec Biologics is an integrated design company focused on all aspects of biotherapeutic technology, from discovery to clinical and commercial manufacturing. We believe that technological innovation accelerates the development of high-quality biologics and significantly reduces their manufacturing cost.

With a flexible approach to partnering, our deeply experienced team offers fully integrated discovery to commercial manufacturing CDMO capabilities and services as well as strategic product partnership opportunities. Our core strengths are AI-driven antibody discovery, molecular design, process and product design and advanced cGMP biologics manufacturing at two facilities. Learn more at www.just-evotecbiologics.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

Operations & Quality Systems Improvement Experts (OQSIE)

Consulting company focused in life sciences with deep expertise in Manufacturing, Quality Assurance, Regulatory Compliance, Supply Chain, and Operational Excellence. We help leaders make significant and sustainable improvements through our four main business segments; Quality & Compliance, Performance Improvement, Technology Solutions, and Workforce Solutions. We’re the premier problem-solvers supporting the industry, offering the highest value at the lowest cost.

oqsie.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

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

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

Alcami Corporation

www.alcaminow.com

Aventior

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

GPB Scientific, Inc.

GPB Scientific is introducing a breakthrough for therapeutic cell production: the Curate® Cell Processing System, a modular, closed-system that replaces today’s inefficient cell separation, washing and concentration methods to deliver higher yields, higher consistency and quality.

The Curate® System promises benefits of faster vein-to-vein time, higher yields of T-central memory or other cells of interest directly from apheresis product, reduced cell population doublings for T- and other gene-modified cell therapies, and exceptional efficiency through a gentle, reagent- and label-free system. Its improved cell quality and yield of Tcm cells provide for the potential of lower T-cell dysfunction during and following therapeutic cell production.

GPB’s Curate® System yields >96% WBC recovery, >95% RBC and >95% platelet reduction. The same platform can be used for washing, concentration and media exchanges downstream. The enhanced yield and quality is projected to reduce the vein-to-vein production by 4-6 days.

gpbscientific.com

groninger

Top players in biomanufacturing trust groninger’s proven liquid fill and finish solutions, consisting of innovative hardware and unparalleled service. Since 1980, innovation and consistent performance made us a world leader with over 1300 employees. Groninger proudly designs and manufactures a comprehensive product range for the pharmaceutical, consumer healthcare, and cosmetics industries. Your groninger machine will deliver reliable quality that meets the latest cGMP and market performance demands.

www.groningerusa.com

Pharmatech Associates

Pharmatech Associates, a USP company, is a global consultancy that has effectively provided life science industry clients with expertise in product and process development, quality compliance, regulatory affairs, and facilities and capital projects including validation for more than 25 years. Headquartered in Northern California we advise clients that range in size from startups to multinational corporations to satisfy global regulatory requirements to bring products to market, scale up manufacturing, effectively manage quality control, and remediate quality problems in a rapidly changing environment.

pharmatechassociates.com

PQE US Inc.

PQE is a complete quality solutions provider (27 offices globally, 1000+ 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

QbDVision powered by CherryCircle

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

www.repligen.com

Wacker Biotech

Wacker Biotech is “THE MICROBIAL CDMO” – your partner of choice for process development and commercial manufacturing of biopharmaceuticals (proteins, vaccines, live microbial products, and plasmid DNA (pDNA)) using microbial hosts. Developed over decades, our plug-and-play platform for pDNA is suitable for manufacturing R&D supplies (non-GMP) up to scale-up to full GMP-compliant production. Wacker Biotech operates a 500 L stainless steel fermentation line and a 30 L single-use bioreactor for DNA production and purification.

Our integrated service portfolio covers molecular biology, process- and analytical development as well as GMP manufacturing of biologics for clinical and commercial supply. Wacker Biotech maintains four GMP-compliant production plants in Amsterdam (The Netherlands), San Diego (US) and in the German cities of Jena and Halle.

www.wacker.com/biologics

Yposkesi

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

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

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

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

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 ExPERT^TM 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

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