Author Archives: BPI Staff

Hot off the Press: Quality by Design for AAV manufacture

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Chemistry Manufacturing and Controls (CMC) for gene therapies is one of the biggest obstacles when moving towards regulatory approval and presents a significant risk to the success of new gene therapy drug candidates today. A key aspect to the CMC documentation of such complex biological products is the application of the Quality by Design (QbD) principle: A rationale of quality being achieved by process design rather than relying on final quality testing alone. The work presented here provides a framework…

November 12, 2021

BioProcess Insider State of the Industry — September 2021 Panel Discussion

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Our BioProcess Insider editorial team sits down with Joshua Speidel, PhD Partner, Latham Biopharm Group, Patrick Lucy, President and CEO, Lykan Biosciences, and Amélie Boulais, Head of Market Entry Strategy, Virus Based Therapeutics at Sartorius, to reflect on how the quarterly movements of the wider pharma industry are affecting the biomanufacturing space. Through the analysis of global events, recent deal making, and regulatory and technological advancements, we look to determine the factors driving or squeezing production and pre-empt upcoming trends…

September 29, 2021

Advanced Instruments buying cell line dev tech firm Solentim

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Advanced Instruments will add antibody and cell-based therapy workflow tech through the acquisition of Solentim. “The coming together of Advanced Instruments’ and Solentim’s core technologies, will be a powerful combination in support of clonal cell line development,†Byron Selman, CEO of Advanced Instruments, said. “With Solentim, we are acquiring innovative technologies that will enhance our ability to support customers in these workflows. We are also adding to our technical capabilities with the addition of imaging, advanced AI capabilities and automation…

August 9, 2021

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

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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…

August 4, 2021

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

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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,…

August 4, 2021

Embrace Molecule Complexity with Optimized Expression Technologies

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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…

August 4, 2021

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

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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…

August 4, 2021

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

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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…

August 4, 2021

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

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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…

August 4, 2021

Comprehensive Target Discovery and Validation at HDB–WuXi AppTec

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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…

August 4, 2021