2017 BioProcess International Industry Yearbook

The biopharmaceutical industry must find a way to reduce overall development costs and time to market. Technology is the key and industry suppliers are the main source of technology — they are critical partners and the key to your success. For this reason, BioProcess International dedicates one issue each year, the Industry Yearbook, to showcase the technologies, products, and equipment that can help you improve your processes and ultimately, reduce your cost and time to market.

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FEATURED REPORT: The BPI Theater @ BIO 2017

The 2017 BPI Theater @ BIO took place June 20-22 in San Diego CA and focused on two main themes: emerging therapies and emerging technologies. The BPI Theater provides convention attendees working and interested in biopharmaceutical research, development and manufacturing with a dedicated destination to meet, network, and experience the latest science and technology trends impacting bioprocessing. Summaries of the presentations were included in the July-August Featured Report, and full video presentations are available for on-demand viewing.

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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…