BPI Theater Archives - Page 4 of 27 - BioProcess InternationalBioProcess International

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

by BPI Staff

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

by Dan Stanton

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:…

Tailoring the Cell Line Development Process to the Specific Molecule and Program Goals

by BPI Staff

Presented by: Gregory Bleck, PhD, vice president, Catalent Biologics Speed and efficiency remain major drivers for developers bringing their protein-based biologics to first-in-human studies. The right cell-line development approach can help streamline a path to clinic for both standard monoclonal antibodies and more complex modalities such as bispecifics. Bleck shared recent data on how the GPEx suite of technologies provides for high titers, short timelines, and flexibility in cell-line development for mammalian-expressed proteins. He began by explaining that protein therapeutics can…

A Multifunctional Single-Use Purification System for Connected and Integrated Continuous Processing

by BPI Staff

Presented by: Charles Heise, PhD, senior staff scientist, bioprocessing and development, Fujifilm Diosynth Biotechnologies Heise focused his presentation on the SymphonX single-use purification system and its role in continuous bioprocessing for the downstream processing of monoclonal antibodies (MAbs). He described how the system enhances the company’s MaruX continuous purification platform. The company sought to meet the requirements of both batch and continuous processing, for which the single-use approach requires different flow paths, presents complex process integration across diverse vendor systems,…

Embrace Molecule Complexity with Optimized Expression Technologies

by BPI Staff

Presented by: Anil Sebastian, group leader, cell culture development; and Joachim Klein, head of microbial strain development and cell banking, Lonza Pharma & Biotech Although monoclonal antibodies (MAbs) remain the most popular modality in the biopharmaceutical industry, new molecular formats (NMFs) such as multitoxin antibody–drug conjugates and multichain antibodies are gaining ground quickly. Such molecules are imposing new demands on gene-expression technologies. Sebastian and Klein described how their company’s solutions support upstream development for therapies based on NMFs. Sebastian highlighted…

Don’t Let the Immune Response Blindside You: The Importance of Early Immunogenicity and Immunotoxicity Assessment

by BPI Staff

Presented by: Noel Smith, head of immunology, Lonza Pharma & Biotech Biopharmaceutical developers are keenly aware of high attrition during preclinical drug development stages. Immunogenicity and immunotoxicity concerns account for many program failures. Thus, developers strive to identify safety concerns as early as possible. By detecting problems early, companies can reengineer their molecules, investigate process-related solutions, or select alternative lead candidates. Smith reviewed methods that Lonza has developed to enhance early immunogenicity and immunotoxicity studies. Smith noted that several factors…

Key Challenges and Potential Solutions for Eliminating Bottlenecks and Optimizing Downstream Operations

by BPI Staff

Presented by: Willie Hesselink, technical application project manager, biopharmaceutical production, Europe, Avantor Investments in cell-culture technologies have increased monoclonal antibody (MAb) yields significantly over the past two decades. Downstream operations continue to lag in productivity, however. Hesselink explored how companies can align downstream productivity with upstream yields to mitigate production bottlenecks. He focused on intensifying chromatography steps, optimizing buffer preparation, and mitigating variations across raw materials. Chromatography resin selection is vital to downstream intensification, Hesselink explained. Capture and polishing steps…

A Behind-The-Scenes Look at Lykan Bioscience’s State-of-the-Art, Purpose-Built Cell Therapy Facility

by BPI Staff

Presented by: Patrick Lucy, president and chief executive officer, Lykan Bioscience Lykan Bioscience is a cell-therapy–focused contract development manufacturing organization (CDMO) based in Hopkinton, MA. Lucy’s presentation showcased his company’s new purpose-built manufacturing facility and described how its design can help to expedite manufacturing of cell therapy products. Emphasizing the highly individualized nature of autologous therapy production, Lucy also explained how the Lykan team integrates its logistical and manufacturing operations to maximize patient access to lifesaving treatments. Lykan’s 64,000-ft2 facility…

Comprehensive Target Discovery and Validation at HDB–WuXi AppTec

by BPI Staff

Presented by: Shelly (Fang) Zhang, director II, exploration biology team leader, HD Biosciences–WuXi AppTec Novel target discovery and validation are the most crucial steps in successful drug development. Zhang presented her company’s evolving advanced gene manipulation (AGM) program, which is propelled by application of clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated protein_9 (Cas9) technologies. The AGM platform supports target discovery and validation for conventional biologics and new modalities. She highlighted a number of technologies in development and their…