BPI Lab: Essential Technologies for Development, Characterization, and QA/QC

BioProcess International and BioTechniques partnered to create this special eBook, highlighting and detailing fourteen analytical technologies that provide laboratory technicians and scientists with vital information to help project managers and engineers make educated decisions that ultimately affect every companies bottom line.

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Continuous Processes: Disposables Integrate Upstream and Downstream Processes

Perhaps the “hottest” buzzwords in biomanufacturing today are continuous processing and single-use technologies. They are closely related — as one is increasingly enabled by the other. Alongside a review of these advancements by BPI’s senior technical editor, contributed articles will expand on continuous upstream/production methods and continuous downstream processing technologies.

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Analytical

Opportunities and Challenges in Biosimilar Development

A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product. Unlike generic small molecules, it is difficult to standardize such inherently complex products based on complicated manufacturing processes. Table 1 describes the main differences between biosimilar and generic drug molecules. The global biosimilar market is growing rapidly as patents on blockbuster biologic drugs expire (Table 2) and other healthcare sectors focus on reduction of costs. Biologics are among…

Business

An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems

Current practices for change notification in the biopharmaceutical industry are neither efficient nor conducive to accelerating the adoption of single-use systems (1, 2). Drug manufacturers (end users) often observe that supplier change data packages lack technical content or detail and that the time allowed for change implementation is too short. Occasionally, customers (end users or next tier in supply chain) learn of changes after the fact, possibly even by happenstance. Suppliers, however, can find the potential affect of a change…

Manufacturing

Difficult-to-Express Proteins: Resolving Bioprocessing Challenges with a Scalable Perfusion Bioreactor

Recent advances in protein engineering have identified new classes of complex biotherapeutics that challenge existing manufacturing platforms. These products have unique cell culture requirements that make them difficult to manufacture cost effectively. Industry standard bioprocessing platforms include large-scale (1,000–5,000 L) batch and fed-batch stirred-tank bioreactors. Historically, the powerhouse molecule of the biologics industry has been human IgG, which necessitates those large-scale platforms. Difficult-to-express proteins and other new modalities (including precision medicine and orphan drugs) have increased pressure on manufacturers to…