BPI Theater

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…

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…

The Changing CDMO Landscape

Contract development and manufacturing organizations (CDMOs) have evolved from simple service providers to full partners. Such companies now offer development and end-to-end services for highly complex biologics in a transition from contract manufacturing organizations (CMOs) and contract research organizations (CROs) to CDMOs. Before 2000, some drug companies (e.g., Merck, Novarits, Boehringer Ingelheim, and others) offered their excess manufacturing capacity to other drug makers. Chemical companies provided fill–finish and related services. Between 2000 and 2008, a number of dedicated CMOs emerged:…