Monday, May 24, 2021 Daily Archives

Avenues for Innovation: The Latest in Cell-Line Engineering and Development

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Plato wrote in ancient Greece that “our need will be the real creator,†which transformed over time into the English proverb, “Necessity is the mother of invention.†Advancements in medicine and biomanufacturing technology in 2020 have epitomized that idea. Even as technologies such as mRNA vaccines have rocketed into the public’s awareness, biomanufacturing experts have worked behind the scenes with renewed vigor spurred on by hard lessons from the pandemic. Cell-line development and engineering are no exception. Already undergoing a…

May 24, 2021

Increasing Expression Titers: New Technologies Could Help Other Cell Lines Catch Up to CHO

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Fang Tian is a lead scientist and head of cell biology research and development at the American Type Culture Collection (ATCC) in Manassas, VA. She is a member of both the International Cell Line Authentication Committee (ICLAC) and the US technical advisory group for the ISO/TC276 technical committee. At ATCC, she oversees preparation, authentication, characterization, quality control, and cryopreservation of more than 3,400 accessioned animal cell lines and hybridomas in the cell biology general collection. She holds a PhD in…

May 24, 2021

Engineering Alternatives: Modern Technology Enables Expression System Developers to Think Beyond CHO Cells

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Major biopharmaceutical companies are teaming up with academics and the Bill & Melinda Gates Foundation to develop new biomanufacturing cell lines and methods. The project — known as the AltHost Consortium — is exploring innovative ways to produce biologics and vaccines for clinical usage in diseases from diabetes to cancer. Lead researcher J. Christopher Love at the Massachusetts Institute of Technology (MIT) likens this precompetitive, open-access collaboration to the early days of the biopharmaceutical industry. “When biomanufacturing first emerged as…

May 24, 2021

Cell-Free Expression: A Technology with Truly Disruptive Potential

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Bioprocess engineer Beatrice Melinek is a postdoctoral research fellow at University College London’s Future Targeted Healthcare Manufacturing (FTHM) Hub, where she focuses on the use of cell-free protein synthesis (CFPS) as a platform for distributed production of stratified biotherapeutics. Previously Melinek specialized in purification of viral vectors and vaccines, with an engineering doctorate (EngD) in biochemical engineering and postdoctoral experience in UCL’s hematology department developing a new chromatography-based analytical method for measuring empty and full adenoassociated virus (AAV) capsids. She…

May 24, 2021

Technologies and Innovations: A Discussion with Selexis SA

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Pierre-Alain Girod is chief scientific officer (CSO) for Selexis SA. He holds a PhD in plant biochemistry from the University of Lausanne in Switzerland and completed a postdoctoral fellowship at the University of Wisconsin in Madison, WI, on the degradation of proteins by the ubiquitin pathway. Girod returned to Switzerland in 1993, where he discovered a family of sequences that are involved in the epigenetic regulation of genes. That discovery subsequently has been used to express therapeutic proteins in the…

May 24, 2021

eBook: ADCs — Evolving Links in the Biopharmaceutical Pipeline

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Antibody–drug conjugate (ADC) developers both old and new are talking about the next generation of drug candidates coming through their pipelines. In April 2021, Zynlonta (loncastuximab tesirine, from ADC Therapeutics) became the eleventh such product to receive approval from the US Food and Drug Administration (FDA). But with dozens of ADC candidates currently in clinical trials, those 11 products represent the tip of the ADC iceberg. In this eBook, Dan Stanton (founding editor of BioProcess Insider) explores ADC production history,…

May 24, 2021

Ins & outs: Resignations as Voyager Therapeutics tweaks strategy

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Voyager Therapeutics CEO and CMO resign. Meanwhile, there are changes at Appia Bio and Acepodia. Get the kettle on, put your feet up, and enjoy BioProcess Insider’s Ins & outs. First up in this week’s Ins & Outs feature is Voyager Therapeutics, a firm focused on developing treatments for neurological diseases. The firm’s search for a new CEO is underway as Andre Turenne announced he will leave the firm in June to pursue undisclosed opportunities. To help with the transition,…

May 24, 2021

Biogen Swiss site GMP ready for aducanumab launch

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Biogen has received GMP certification at its Solothurn, Switzerland facility ahead of a regulatory decision for potential Alzheimer’s drug aducanumab. Biogen commissioned the CHF 1 billion ($1 billion) monoclonal antibody production facility in Luterbach, Solothurn, in 2015, stating at the time it would offer 144,000 L of stainless-steel capacity, comprising of eight 18,000 L bioreactors with an output of 10 metric tons. Last week, Swiss Agency for Therapeutic Products (SWISSMEDIC) granted the facility a Good Manufacturing Practice (GMP) multi-product license,…

May 24, 2021

Bluebird welcomes CHMP nod for CALD gene therapy

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Bluebird Bio says Skysona – a treatment for the neurological disease CALD – is a step closer after a thumbs-up from EMA reviewers. The European Medecines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the therapy and issued an approval recommendation last week. The CHMP said the advice was based on a study in which Skysona (elivaldogene autotemcel, formerly Lenti-D) preserved motor function and communication ability and improved survival in 90% of patients…

May 24, 2021