Friday, June 22, 2018 Daily Archives

Accelerating Vaccine Production Using a Nonviral Enabling Technology for Cell Engineering

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At the recent World Vaccine Conference, Victor Ayala, PhD, an early stage investigator with Advanced BioScience Laboratories, Inc. (ABL), discussed how to accelerate vaccine production using a nonviral enabling technology for cell engineering. ABL is a contract research/manufacturing organization (CRO/CMO) providing manufacturing and laboratory research services to advance leading vaccines and therapies from clinical development to the commercial market. The company has been conducting R&D research for over 55 years and performing CMO manufacturing for over 25 years. With more…

June 22, 2018

eBook: Quality By Design for Monoclonal Antibodies — Establishing the Foundations for Process Development, Design Space, and Process Control Strategies

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The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate as well as improve manufacturing processes within defined ranges without obtaining regulatory approval first. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials affects a final product (1). Historically, product quality has been assured either with end-product testing…

June 22, 2018

CAR-T Firm Autolus Raises $150m in IPO

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Autolus Therapeutics has gone public and says it is looking to build its own T cell therapy manufacturing capabilities. Autolus launched its initial public offering (IPO) in May, and today the firm said it has raised approximately US$150 million ( €129 million) and has begun trading on the Nasdaq Global Select Market under the ticker symbol “AUTL.†The London, UK-based firm is a gene therapy developer working on personalized Chimeric Antigen Receptor (CAR) T cell therapies for cancer using its…

June 22, 2018

Pfenex: Bacterial System Overcomes Protein Challenges, Inhouse and Out

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“The more you engineer a protein, the less natural it becomes,†says Pfenex executive Patrick Lucy. The firm is using its clinically validated microbial expression platform to overcome these challenges for both its own product pipeline and its partners. In May, Pfenex announced positive Phase III data showing its lead candidate PF708 is comparable with Eli Lilly’s osteoporosis drug Forteo (teriparatide). The candidate – classed as a biosimilar in Europe but being filed in the US as a therapeutic equivalent…

June 22, 2018