Cell/Gene Therapies

BioProcess Insider Interview: Tom VanCott, Catalent

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Tom VanCott, PhD, Global Head of Product Development, Catalent. Contract development and manufacturing organization (CDMO) Catalent has expanded significantly over the past decade through strategic acquisitions and investments in cell and gene therapy (CGT) capabilities. VanCott reflected on how his company has supported such growth while manufacturing SARS-CoV-2 vaccines and therapeutics. Catalent was able to accommodate the sudden and extraordinary demand for COVID-19 products because it already had been increasing capacity…

BioProcess Insider Interview: Claudia Melara, Gamma Biosciences

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Claudia Melara, Vice President of Key Accounts, Gamma Biosciences. Since its launch in 2020, Gamma Biosciences has acquired or purchased controlling stakes in several solutions providers, the capabilities of which now span the entire biomanufacturing spectrum. Gamma Bio helps drug developers move their products from preclinical research through good manufacturing practice (GMP) production. To spur on commercialization of advanced therapies, Gamma Bio now has established a key accounts program. Drug developers…

Cell and Gene Therapy Modalities: Business and Manufacturing Strategies Influencing the Decision to Develop One Therapy Type Instead of Another

Moderator Patricia Seymour opened the panel by asking each presenter to introduce himself and his company’s technology. Caribou Biosciences: Cell Therapies Panelist Justin Skoble (vice president of technical operations with Caribou Biosciences) is responsible for developing the company’s next-generation CRISPR genome-edited cell therapies. Before joining Caribou in 2019, he was chief development officer at Acton Therapeutics and served in positions of increasing responsibility in immuno-oncology and vaccine development at Aduro Biotech, Anza Therapeutics, and Syros. His experience encompasses development of…

Cell and Gene Therapy: Introducing New Technologies to Compress Timelines, Increase Capacity, and Reduce Risk

Moderator Nicholas Vrolijk (managing director, BPTG, BDO USA) opened the second panel on therapeutic cell and gene therapy by introducing the participants. David Chang (CEO, WuXi Advanced Therapies) has 30 years in the industry with prior experience at Celgene, Roche Genentech, Biogene, and BASF. He has worked in cell and gene therapy and biopharmaceutical technical development, manufacturing operations, engineering, and strategy. Chang: WuXi Advanced Therapies is a globally integrated CTDMO providing front-end research and discovery all the way through development,…

Platform Processes Accelerating AAV Vector Production from Gene to Clinic

Tom VanCott, PhD, global head of product development, Catalent Biologics. VanCott emphasized the difficulty of manufacturing cell and gene therapies, noting the large demands for such products from both companies and patients. Manufacturing complexities include the need for raw materials — plasmids, DNA, viral vectors, and cells. Not only is scale-up difficult, but current supply-chain interruptions are slowing access to reagents, media, and disposable bags and resins. VanCott described Catalent’s approach to accelerating delivery of cell and gene therapy treatments…

The Future of AAV Gene Therapy Is Scalable

Ryan Cawood, chief scientific officer, WuXi Advanced Therapies. Cawood began by noting that WuXi Advanced Therapies supports clients throughout their journeys toward developing cell and gene therapies. With the acquisition of the UK-based contract research organization (CRO) Oxgene and its adenoassociated virus (AAV) and lentivirus platforms (known as the TESSA and LentiVEX platforms/technologies, respectively), WuXi Advanced Therapies now can scale processes up to good manufacturing practice (GMP) manufacturing through to commercial supply. After describing the work that takes place in…

Innovation as the Key to Gene Therapy Manufacturing

David Backer, chief commercial officer, Oxford Biomedica. Backer described the business models of Oxford Biomedica and Oxford Biomedica Solutions. The public company, OXB, licenses its technology. It historically has focused on lentiviruses but has moved into AAV. End-to-end capabilities are offered at both the Boston and Oxford sites. The company has grown rapidly because even though it specializes in lentivirus production, it was asked to increase its capabilities to manufacture an adenovirus-vectored COVID-19 vaccine for AstraZeneca as part of a…

Accelerating Industrialization of Genomic Medicine

Clive Glover, general manager, gene therapy, Pall Corporation. Glover observed that demand continues to grow for genomic medicines such as virally delivered gene therapies and RNA-based vaccines and treatments. With several such products approaching regulatory approval and many more in the clinical pipeline, manufacturing delays are inevitable. One strategy for reducing bottlenecks involves standardizing production processes for viral vectors and lipid nanoparticles (LNPs) that are used to deliver genomic therapies. Glover described the work of his company and other Danaher…

Roundtable Discussion — Recombinant Protein Manufacturing: Lessons to Be Taken from the Emerging Cell and Gene Therapy Space

Dan Stanton (cofounder and editor of the BioProcess Insider) opened the BPI Theater at BIO with the first panel discussion of the week. He noted that current news focuses on overcoming manufacturing issues that impede bringing cell and gene therapies to market and, crucially, producing them in the most cost-effective ways possible. By comparison, the first monoclonal antibody (MAb) product was launched in 1986, so after 35 years, much progress has been made in the traditional biologic space toward making…

Increasing the Efficacy and Impact of Cell and Gene Therapies

Decades of research into cell biology, gene editing, and biomanufacturing have culminated in the commercialization of more than a score of cell and gene therapy (CGT) products. In the United States, most of those are hematopoietic progenitor cells (HPCs) isolated from human umbilical cord blood. As of July 2022, the US Food and Drug Administration has approved five products based on chimeric antigen receptor (CAR) T cells, all since 2017, and two viral-vector gene therapies, beginning with the 2019 authorization…