Manufacturing

eBook: MSC-Derived Extracellular Vesicles Challenges in Production, Scale-Up, and Characterization

The discovery of extracellular vesicles (EVs) as an intercellular communication medium has led to explorations of their therapeutic potential. EVs constitute a heterogeneous mixture of several different vesicle populations that may be similar in size but different in content, or vice versa. The vesicles can contain RNAs and proteins as well as DNAs and lipids as biological cargoes. Those cargoes can exist either intraluminally within EVs or on their surface, adding complexity to analytical considerations. EVs are classified into subpopulations…

How Our Partnerships Move Your Life-Changing Biologics to Market: Two Case Studies

Muctarr Sesay, chief scientific officer, Goodwin Biotechnology. Goodwin Biotechnology’s mission is to minimize manufacturing risks associated with complex biopharmaceuticals, including antibody–drug conjugates (ADCs), bioconjugated vaccines, and multispecific antibodies. Sesay described his company’s capabilities, which span from preclinical process development through commercial supply. Currently, the Goodwin site in Fort Lauderdale, FL, is equipped for 200-L and 500-L bioreactors in both stainless-steel and single-use formats. The company can perform drug substance and drug product manufacturing as well as fill–finish steps, all according…

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: Dave Backer, Oxford Biomedica

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: David Backer, Chief Commercial Officer, Oxford Biomedica. Early in 2022, Oxford Biomedica (OXB) purchased a majority stake in Homology Medicines. The companies have taken similar journeys, the primary difference being that they have worked with lentivirus (LV) and adenoassociated virus (AAV) vectors, respectively. Both companies started as drug developers and established manufacturing capacity to support internal products. Because of program attrition, OXB began offering its capabilities as a service. OXB now…

BioProcess Insider Interview: Brian Finrow, Lumen Biosciences

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Brian Finrow, Co-founder & CEO, Lumen Biosciences. Although Chinese hamster ovary (CHO) cells remain the biopharmaceutical industry’s preferred expression system for antibody production, companies such as Lumen Biosciences are seeking out alternative hosts. Finrow cautioned that CHO cells sometimes complicate efforts to develop scalable and cost-effective manufacturing processes. For gastrointestinal (GI) indications such as Clostridium difficile infection and Crohn’s disease, spirulina, a biomass composed of cyanobacteria and their cellular by-products, could…

BioProcess Insider Interview: Jon Gunther, Just-Evotec Biologics

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Jon Gunther, Head of Business Development, Just–Evotec Biologics. Evotec’s presence in the biopharmaceutical industry grew significantly with its May 2019 acquisition of Just Biotherapeutics. The combined company now provides integrated research and development (R&D) services and good manufacturing practice (GMP)-grade production processes for antibody (Ab) therapeutics. Just–Evotec already has established a manufacturing facility in Redmond, WA, and has initiated construction of a sister site in Toulouse, France, which should come online…

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…

BioProcess Insider Interview: James Park, Samsung Biologics

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: James Park, Executive Vice President, Samsung Biologics. Samsung Biologics has established itself among the world’s largest CDMOs. It currently provides 364,000 L of bioreactor capacity, primarily in stainless-steel format, across three sites in Songdo, South Korea. Park reported that construction continues on a fourth facility. In October 2022, the plant will bring six 10,000-L bioreactors online for GMP production of recombinant proteins. A second construction phase is scheduled to add 12…

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,…