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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…

How a Robust, Fully Integrated, and Highly Vetted Cell-Line Development Platform Accelerates IND Timelines

Sherry Gu, senior vice president of CMC management, WuXi Biologics. Since 2020, WuXi Biologics has supported process development and manufacturing for more than 30 biopharmaceuticals associated with COVID-19. Those include three authorized/marketed products and multiple advanced clinical candidates representing modalities such as monoclonal antibodies (MAbs) and vaccines. Gu explained how her company’s integrated platform for cell-line development (CLD) has enabled customers to advance their programs rapidly. The company’s custom protein-generation services support research and development (R&D) activities, culminating in developability…

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…

Partnering with a CDMO: Past the Service Offering

Elie Hanania, PhD, vice president of process development for viral vector technologies, Avid Bioservices. Speaking as a representative of a global biopharmaceutical manufacturer, Hanania explored several considerations for identifying a suitable third-party manufacturer. Developers approach contract development/manufacturing organizations (CDMOs/CMOs) for different reasons. Biotechnology start-ups often lack internal capabilities for producing clinical-trial drug substance; thus, many such companies leverage CDMOs’ capacity and process-development expertise. Large, established pharmaceutical companies might work with contract partners to free up internal capacity for other products,…

Overcome Costly Hit-Finding Challenges Using an Integrated Platform

Thomas Meins, global head of protein production, HitS Unit, WuXi AppTec. Meins reflected that WuXi AppTec established the HitS Unit 15 years ago to facilitate drug discovery for protein biologics. Today, the unit provides a rapid and cost-effective platform for protein generation, screening, biophysical and biochemical analysis, structural determination, and “hit” confirmation. As of July 2022, the unit has produced assays for more than 1,500 recombinant proteins, including multisubunit complexes, DNA- and RNA-modifying proteins, and membrane proteins. Around 1,200 have…

How a Premier, Single-Source Platform Accelerates Biologic Drug Discovery and Innovation

Jijie Gu, chief scientific officer, WuXi Biologics. WuXi Biologics has established itself as a contract research, development, and manufacturing organization (CRDMO) with comprehensive capabilities for multiple biopharmaceutical modalities. Gu presented on advances that his company has made in contract research for drug discovery. WuXi Biologics provides services for target evaluation, antibody generation, lead identification and optimization (LI and LO), developability study, and regulatory submission. The company leverages multiple platforms to accelerate LI, including an improved murine hybridoma technology with optimized…

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…

Shortening Clinical Development Timelines Using Novel Technology for Generating Stable, High-Producing Cell Pools and Cell Lines

Greg Bleck, vice president of research and development, Catalent. Bleck described Catalent’s work in creating the GPEx Lightning cell-line development platform, which combines three key technologies to accelerate work to produce high-expressing cell lines. The platform combines a GPEx retrovector for gene insertion with a glutamine synthetase (GS) knockout cell line and a recombinase- or transposase-like system that “flips” genes into place. Catalent scientists insert the genes for dedicator-of-cytokinesis (DOCK) proteins — which are involved in intracellular signaling — at…

Rapid Screening of Bioavailability: Enhancing Technologies to Accelerate Time to Clinic

Jesus Rosales, senior scientist in oral formulation development, Catalent. Rosales highlighted efforts to accelerate small-molecule products into clinical development. His company uses rapid formulation prototyping and both in silico and in vitro tools for technology selection. Early phase development is a tortuous path for every drug type, from identifying and validating targets and leads to optimization of drug products. Many options are available for oral solid-dose products: basic powder forms that are reconstituted in a clinic, capsules containing only the…

Improvements and Innovations in Lentiviral Manufacture

Ryan Cawood, chief scientific officer, WuXi Advanced Therapies. In this presentation, Cawood focused on transient lentiviral manufacturing, plasmid creation and analysis, and stable cell-line development for continuous lentiviral production. The work is performed at WuXi Advanced Therapies facilities in Philadelphia, PA, based on methods developed at the company’s research institute in Oxford, UK. The latter site was Oxgene, a company that Cawood founded and that was acquired by WuXi Advanced Therapies in 2021. The WuXi Advanced Therapies transient lentiviral manufacturing…