Speakers

Excellos

Bronze Sponsor

Excellos is a unique full-service CDMO that pairs the collection of critical human cells and tissues with manufacturing and development services to drive innovation in the cell and gene therapy industry. Built on the foundation of the San Diego Blood Bank, with over 70 years of experience in blood and tissue collection and handling, Excellos is focused on supplying cGMP cellular products and services, together with process development and manufacturing expertise to scientists and clinicians working with cell and gene therapies.

Speakers

Andelyn Biosciences

Silver Sponsor

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 

Speakers

Project Farma

Silver Sponsor & Exhibitor

Project Farma is an industry leader in technical operations strategy and manufacturing execution to cell and gene therapy companies. Our strategy services include due diligence; GMP infrastructure startup & support; make vs. buy analysis; and program management.  Our execution services include large capital projects, facility builds & tech transfers; quality, regulatory & compliance; engineering & automation; validation; and reliability and maintenance. 

 We have led the manufacturing strategy and execution of GMP compliant, advanced therapy facilities from 5,000 to over 500,000 sq. ft. and have built the largest cell and gene therapy manufacturing footprint in the world. 

Speakers

AGC Biologics

Silver Sponsor & Exhibitor

AGC Biologics is a global CDMO providing pharmaceutical process development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, we have the resources and the available capacity you need to accelerate your race to GMP. From development to clinical trials to full-scale commercialization, we can help you reach your goals at any stage in the drug development and manufacturing process. We specialize in the following modalities and substances: mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA, viral vectors, Messenger RNA (mRNA), and genetically engineered cells. Our services range from Process Development, Analytical Development, cGMP Manufacturing (both clinical and commercial), Quality Control, and Quality Assurance and Process Validation.

Speakers

Genezen

Exhibitor

Founded in Indianapolis in 2014, Genezen is focused on supporting the demands of the current and future gene and cell therapy manufacturing market worldwide— making viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen offers the following capabilities, building on the company’s expansive knowledge and experience in the industry and working with the nation’s leading institutions:

  • Process Development
  • Analytical Development
  • cGMP Lentiviral and Retroviral Vector Manufacturing
  • Patient Sample Testing
  • Cell Therapy Manufacturing
  • Master Cell Bank Production and Expansion

We leverage our state-of-the-art facility to allow for flexible manufacturing capacity and scale-up supported for both adherent and suspension platforms using producer cell lines, cell factories, and fixed-bed bioreactors. With our goal to lead with science, Genezen’s core mission is to deliver life-changing therapies through flexible support for cell and gene therapies, from early-stage through to the clinic.

Speakers

Gamma Bio

Silver Sponsor & Exhibitor

Gamma Biosciences is a leading life sciences company providing products and services to support the development and manufacturing of advanced biologic therapies. Our operating companies are committed to advancing the science and art of bioprocessing by delivering market-ready innovation and expertise that helps our customers. Gamma Biosciences encompass biopharmaceutical companies, contract developers and manufacturing companies. Our goal is to safely bring therapies to patients quickly and efficiently. Gamma is a global company with offices and major manufacturing facilities in North America, the U.K. and Belgium.

Speakers

IQVIA

Associate Sponsor

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 67,000 employees worldwide. Learn more at www.iqvia.com. 

Speakers

Asimov

Silver Sponsor & Exhibitor

Asimov builds tools to program living cells. Our mammalian cell engineering platform advances the design and manufacture of biologics and gene therapies. The Asimov lentiviral producer cell line service delivers monoclonal suspension HEK293T-based inducible cell lines containing all necessary elements for VSV-G pseudotyped lentivirus production. The cell line development process takes 3-4 months from DNA synthesis to research cell bank. This process eliminates the need for multiple costly and time-consuming GMP-grade plasmid batches throughout the clinical and commercial stages. 

Speakers

Autolomous

Silver Sponsor & Exhibitor

Autolomous LTD is the market leading developer of critical manufacturing management systems for cell and gene therapies. Autolomous internationally deploys fully integrated, digitized and automated supply chain software solutions. These solutions utilize emerging technologies such as Distributed Ledger Technology (DLT) and Internet of Things (IoT) to ensure compliance with current and future regulatory requirements. As a result, Autolomous enables manufacturers to reduce costs and deliver cell and gene therapies to more patients.

Autolomous’ platform, AutoloMATETM is a business-critical robust digital solution increasing efficiency, scalability and process streamlining of the GMP manufacturing and product release of cell and gene therapies.

Autolomous LTD is headquartered in London.

Speakers

Forge Biologics

Silver Sponsor & Exhibitor

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge has a 200,000+ square foot facility in Columbus, Ohio, The Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV vector manufacturing and will 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.  To learn more, visit www.forgebiologics.com