Wednesday, August 24, 2022 Daily Archives

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…

Advancing Biomanufacturing Capabilities with a Next-Generation Single-Use Solution

Charles Heise, senior staff scientist in bioprocessing strategy and development group, Fujifilm Diosynth Biotechnologies. Heise presented work Fujifilm Diosynth Biotechnologies has done to debottleneck downstream processes for continuous operations and high-titer product batches. He highlighted the benefits of automation and data management, closed processing, and advanced buffer management — all together in the SymphonX system. A disposable flow path provides buffer-management capability through standard software for “multifunctional” operations. The company wanted one “rig” to perform all the necessary downstream functions,…

Using Innovation and Investments to Advance Nanoparticle Formulations

Tara Lorenz, director of commercial development, Emergent BioSolutions. Lorenz presented two case studies: one demonstrating technology transfer of a liposomal immunotherapy using extrusion technology and the other describing process performance qualification (PPQ) of a lipid nanoparticle (LNP) formulation for mRNA delivery. The first example product is a self-assembling, protein-based nanoparticle vaccine that’s now in phase 1 clinical testing. The second project involves peptide–mRNA nanoparticle therapeutics against specific cancer targets. Emergent operates three centers of excellence for nanoparticle-based formulations, each with…

Crossing the Finish Line: Preparing for and Passing a Preapproval Inspection

Ray Marzouk, vice president of quality, Avid Bioservices. Since Avid’s first commercial approval in 2005, the company has been inspected multiple times by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Brazilian Health Regulatory Agency, and Health Canada. Avid makes drug substance for products that are approved and marketed in more than 90 countries. The company has succeeded in eight preapproval inspections (PAIs), the most recent five of which had no 483 observations. PAIs differ…

Thermo Fisher: $180m MA viral vector plant opens doors

Thermo Fisher adds 300,000 square feet of gene therapy manufacturing capabilities through the opening of the Plainville, Massachusetts plant. In the same week a Thermo Fisher facility capital expenditure came to fruition in its single-use materials business, the life sciences services firm has announced a viral vector plant expansion is complete. The Plainville plant was commissioned in May 2020 at a cost of $180 million and, now open, effectively doubles the firm’s commercial viral vector capacity in supporting increased demand…

Cellipont upping cell therapy offering with Texas plant

The first phase of the expansion project will add up to seven cleanroom suites for large-scale autologous and allogeneic cell therapy production, says Cellipont. Cellipont Bioservices, previously known as Performance Cell Manufacturing, has expanded rapidly since its acquisition by private equity firm Great Point Partners earlier this year. In May, the San Diego-based contract development and manufacturing organization (CDMO) announced plans to expand cell therapy development and manufacturing capabilities at its Poway, California facility, and now Cellipont is planning a…