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Featured Reports

15-3-FR-CoverPublished as 24-page limited sponsored special reports within select scientific issues, then electronically delivered to BPI’s readers, BPI’s 2017 featured report series provides high level analysis of the most important applications supporting biopharmaceutical development. The combination print and electronic delivery platforms ensures maximum distribution
and highly qualified lead generation.

January 2017: Downstream Developments in Single-Use Technology Although the earliest disposables for bioprocessing were filter cartridges, the upstream/production single-use applications surpassed downstream technologies along the way. But separation and purification technologies are catching up, and now even drug-product filling operations have single-use options.

February 2017: Current Developments in Processing Cell, Gene, and Tissue Therapies Phase-appropriate development strategies are needed in regenerative medicine. Cell therapy manufacturers are developing 2D and 3D platforms. Gene therapy companies are developing scalable solutions for adenoassociated viral vector purification, and tissue therapy organizations are showing promise engineering 3D bioprinting as well as “body on a chip” platforms as development strategies.

March 2017: Trends in Outsourcing: Who, What, When, Where, and How Contract service providers are by necessity eager adopters of new manufacturing technologies. Contract services are available now in geographic regions new to industrial biopharmaceutical development, and many providers are focusing their business on emerging therapies.

April 2017: Technical Challenges in Biosimilar Development Biosimilar product development seeks to make biopharmaceuticals affordable for a broader market. But although regulatory pathways allow developers to bypass certain expensive testing steps, biosimilars are not generic drugs.

May 2017: Single-Use Technologies Enable Continuous Bioprocessing Perhaps the “hottest” buzzwords in biomanufacturing are continuous processing and single-use technologies. Perfusion and other approaches are blurring the line between upstream and downstream processing, and suppliers are offering solutions to continuous drug-substance purification.

July/August 2017: BPI Theater BPI readers can enjoy reading summaries from talks presented at our BioProcess Theaters, held annually at the Interphex and BIO conferences. Those summaries, derived from transcripts, lead readers to the full recordings (with slides) appearing on the magazine’s web site. Topics include outsourcing/contract services, single-use technologies, continuous processing, and biopharmaceutical training programs.

September 2017: Emerging Therapies: Advancing Next Gen Recombinant Proteins Nontraditional biotherapies such as antibody-drug conjugates (ADCs), recombinant vaccines, antibody fragments, bispecific antibodies, and fusion proteins require different processing approaches than traditional, well-established biologics. Challenges with the production of these therapies, including their characterization, clinical and assay development, setting process specifications, and site-specific conjugation must be addressed to ensure financial viability.

October 2017: Training the Next Generation of Bioprocess Experts Training budgets at biopharmaceutical companies are often strained past the ability to offer more than “read and understand” approaches. And college/university graduates are often unprepared for GMP-level compliance and modern equipment operation. Therefore, more universities and community colleges are developing training programs in collaboration with industrial partners and nonprofit groups devoted to developing curricula.

November 2017: Process Monitoring and Control Solutions for Modern Facilities With the emphasis on quality by design (QbD), biomanufacturers are using a risk-based approach to bioprocessing. Such strategies generate huge amounts of data, which must be linked to process efficiency and product quality. Solutions to help optimize process systems include single-use sensors, data tracking, process modeling and simulation, enterprise-resource planning systems, assay monitoring for aggregation, and control systems for batch and continuous production systems.