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BioProcess Insider Interview: Greg Bleck, Catalent

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Greg Bleck, Vice President of Research and Development, Catalent. In July 2021, Catalent released its GPEx Lightning expression construct for Chinese hamster ovary (CHO) cell-line development (CLD). Bleck characterized it as a novel combination of the company’s original GPEx retrovector gene-insertion technology, a glutamine synthetase (GS) knockout sequence, and a recombinase gene-insertion system. A key advantage of the platform, Bleck explained, is that it can reduce CLD timelines by three months.…

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: Emmanuel Ligner, Cytiva

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Emmanuel Ligner, Chief Executive Officer, Cytiva. In 2021, Cytiva collaborated with London’s Financial Times survey group to establish an annual biopharmaceutical industry resilience index. Ligner explained that his company spearheaded the project to quantify life-science leaders’ confidence in the industry and to identify areas for improvement. The inaugural survey collected impressions from more than 1,000 executives about supply-chain resilience, talent recruitment, research and development activity, manufacturing agility, and regulation. The industry…

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,…

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…

Building a Comprehensive Toolbox for Oligonucleotide Drug Discovery

Dave Madge, vice president, WuXi AppTec. Dave Madge oversees a number of WuXi AppTec’s preclinical discovery services from his base in Cambridge, UK. He spoke about his company’s capabilities in building new modalities, in particular for oligonucleotide therapeutics. Following an introduction on new modalities and oligonucleotides, he presented a workflow for discovery, chemistry, and biology for siRNA therapeutics, focusing on synthetic DNA and RNA therapeutics. Two main factors contribute to the importance of alternative modalities. First, within the small-molecule and…