EDITOR'S DESK

3 Things You Didn’t Hear Coming Out Of JPM

You’ve heard San Francisco was buzzing with cautious optimism last month. You’ve seen the M&A activity that’s buoying spirits and you know inflation and interest rates are stabilizing, if not improving. You may not have considered these three trendlines, offered by a guy who spent his time at JPM doing more listening than anything. 

2023 ADC Roundup: A Year Of Collaboration And Licensing Deals

Despite the continuation of a poor funding climate in biotech, 2023 was a big year for antibody-drug conjugates (ADCs). 

RNA Vaccines: Just Scratching The Surface

RNA vaccines have shown promise in preventing infectious diseases and treating cancer, but clinical development varies markedly between the two. HDT Bio’s Dr. Berglund discusses this and how they can be improved.

How Creative Licensing Can Improve Patient Access

Members of Caring Cross and UC Berkeley's Innovative Genomics Institute and Office of IP And Industry Research Alliances discuss the important role technology transfer offices (TTOs) play in improving ATMP accessibility. TTOs can accomplish this by designing "strings-attached" research and licensing deals upstream in product development.

GUEST COLUMNISTS

  • Risk And Supply Chain Continuity Management: Biologics Industry Perspectives

    We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.

  • Understanding And Navigating Diverse Regulatory Environments

    Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.

  • A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies

    Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.

  • Developing & Implementing A Continuous Bioprocess Control Strategy

    A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.

  • Huh? Where Did That Environmental Monitoring Hit Come From?

    After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.

  • A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

    The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.

  • FDA’s CBER Issues Final Guidance For CAR T Cell Products

    The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.

  • New DSCSA Guidance Details Layers Of Verification System Requirements

    A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.

BIOPROCESSING WHITE PAPERS

BIOPROCESS ONLINE CONTENT COLLECTIONS

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This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.

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