Author Archives: Alison R. Carter

In Search of a CMO for My Biotechnology Startup: How to Navigate a Journey Without Process Maps

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An innovative biopharmaceutical product can transform from an abstract idea at small scale into the basis of a burgeoning startup company. At that point, company leaders seek ways to ensure that a biologic will scale up in a quality-controlled, professional, and sustainable environment. That involves refining a research-stage prototype into a product that will be consistent and reproducible for research and development (R&D) and manufacturing and that will meet all relevant regulatory standards in specified target markets. Within the constraints…

February 4, 2022

A Multistep Research Protocol to Develop and Implement Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)

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Pursuant to the proposal for validated minimum standards for biopharmaceutical contract manufacturing organization (CMO) request-for-information (RFI) and request-for-proposal (RFP) processes (biopharmaceutical vendor evaluation and selection minimum standards, BioVesel) (1), we propose herein a multistep research protocol to develop and implement the BioVesel standards. This proposal is intended as a basis for discussion among mulitple stakeholders. Detailed research protocols for each proposed stage in the development and implementation of BioVesel will be drafted and published separately. The context of the proposed…

December 14, 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