Business

Building a Bridge Across the “Valley of Deathâ€: Strategies to Help Support Technology Development

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On Thursday 6 September 2018 at the annual BioProcess International Conference in Boston, the first “Technology Round Robin Featuring Six Innovative Bioprocess Technologies†was presented in an interactive session with attendees as active participants, asking questions and engaging in conversation with the six featured entrepreneurs. Detailed below, this session was a culmination of several steps in an overall strategy for some of the companies participating. To fully appreciate the launch of new technologies into the bioprocess arena, you first must…

December 14, 2018

Elucidation: Changes in VA Healthcare Pose New Implications for Drug Companies

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Veterans of the US military still struggle to access healthcare despite the 2014 congressional passing of the Veteran’s Choice Program (VCP), a US$10 billion-dollar “fix†that allows qualifying veterans to see community physicians who have contracted with the Department of Veterans Affairs (VA) to provide care. Veterans who enrolled in VCP to avoid long wait times at department medical facilities still have faced month-long delays before seeing a doctor, according to a 2018 GAO report. Investigators have found that the…

December 14, 2018

The Complete e-Book of Biosafety Testing

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Expect the expected. But plan for the unexpected. If your Biosafety Development takes a nose dive, Eurofins Lancaster Laboratories’ team of regulatory experts and experienced scientists will help you land safely on two feet. Download The Complete e-Book of Biosafety Testing to learn more about our expertise in biologics raw materials, cell bank preparation, adventitious virus testing, viral clearance studies, next-generation sequencing, genetic stability testing, and more. This e-Book contains the following chapters: Mitigating Risk and Reducing Regulatory Scrutiny of…

December 12, 2018

Partnerships in Immunotherapy: Working Together to Take Cancer Treatment to the Next Level

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Biopharmaceuticals are a particularly complex expression of medicine — and immunotherapies perhaps even more so. As treatments, these products themselves often also need “partners†of a kind: e.g., radiation/radiotherapies, traditional MAbs, and chemotherapies. Just as this field of endeavor requires the input and expertise of many different disciplines — from medical researchers to process engineers, clinicians to business leaders, and market experts to policy makers — this discussion of the topic of partnerships in immunotherapy brings together different experts in…

November 27, 2018

Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant

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Triton X-100 detergent makes an interesting case study in bioprocess sustainability strategy. Also known as octylphenol ethoxylate (OPE), this nonionic surfactant has many uses in biopharmaceutical research and development. Among other laboratory applications, it is used to lyse cells and DNA in research, to solubilize membrane proteins and decellularize animal-derived tissues, to reduce the surface tension of aqueous solutions during immunostaining, and to remove sodium dodecyl sulfate (SDS) from polyacrylamide gel electrophoresis (PAGE) gels for analysis. It also serves as…

November 9, 2018

Viral Risk Mitigation: A Global Regulatory Perspective

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The production of biologics will always have the risk of viral contamination. Manufacturers have developed a multitiered approach — tailored to individual processes — to prevent adventitious viruses from entering production processes, detect contamination in raw materials and process intermediates, and remove viruses in downstream purification. This article provides an overview of the global regulatory framework to ensure the viral safety of biologics. Past Contamination Events Past contamination events have resulted in corrective and preventative actions to reduce the risk…

October 30, 2018

BioProcess International Conference and Exhibition 2018 Postevent Report: Key Insights, Highlights, and Take-Away Messages

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From the global shift in demographics to increased efficiencies in chromatography media, change is constant within the bioprocessing industry and a major reason delegates flock to the annual BPI Conference and Exhibition. As a place to get an overview of the hot topics affecting this industry, the meeting brings together key aspects of bioprocessing — therapeutic modalities, cells, expression systems, upstream production, downstream processing, development, and manufacturing — with digital integration and the increasing importance of analytics. Add in macrobusiness…

October 22, 2018

Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)

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Three major concerns predominate biotechnology executive management in organizations of all sizes and above all other risks: finance (or its absence at critical moments), technological performance, and failures in coordination. Some business functions, such as human resources (HR), are effectively siloed horizontally and therein are more likely to be susceptible to only one of those risks (1). Few functions are subject to this trinity of risks simultaneously; all functions may be exposed to failures in internal coordination, and a smaller…

October 15, 2018

Cell Culture Media: An Active Pharmaceutical Ingredient or Ancillary Material?

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Cell-based therapies are used to treat diseases that require the replacement of diseased, dysfunctional, and injured cells (1). To produce these therapies, a wide range of reagents and materials such as antibodies, growth factors, and enzymes are used in their manufacturing processes. Such necessary materials are administered through a cell culture medium. Active pharmaceutical ingredients (APIs) are the main ingredients that make products therapeutic. Ancillary materials (AMs) and raw materials (RMs) are essential components used during production but are not…

September 27, 2018

Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities

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New technologies bring new regulatory challenges. The biopharmaceutical industry must be cautious in its implementation of new scientific ideas and technology platforms — no matter how promising those might be. Regulators will look skeptically on any claim that isn’t backed up by good data, and with no solid history of successful use to build on, a company must have all the answers itself. How do compliance professionals anticipate what kinds of questions reviewers will ask when the time comes —…

September 25, 2018