Bioreactor titers for monoclonal antibody (MAb) processes have increased significantly since the dawn of the biopharmaceutical industry, yet such gains have instigated bottlenecks for critical high-volume raw materials used in downstream processing, such as buffer solutions. As downstream purification is required for most, if not all, biopharmaceutical products, buffers and their preparation are topics that concern nearly every drug company. But those topics rarely receive direct attention. This BPI eBook explores what factors prompted the current buffer bottleneck and what options drug sponsors might consider to negotiate such hurdles to operational efficiency. First, a BPI editorial advisor and executive director of the Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) contextualizes the buffer bottleneck, then lays out scientific, operational, logistical factors that end users should consider when deciding whether to in- or outsource buffer production. Following that discussion, biopharmaceutical-industry consultants from Alira Health share their interviews of a buffer-chemical supplier and end user. The interviews explore strategies for mitigating shortages of chemicals used in raw materials. Read this eBook to learn more about the complex precision, validation, and supply-chain considerations that undergird what merely seem to be simple bioprocess solutions.
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