2021

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

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…

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

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…

Cell-Free Expression: A Technology with Truly Disruptive Potential

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…

Technologies and Innovations: A Discussion with Selexis SA

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…

eBook: ADCs — Evolving Links in the Biopharmaceutical Pipeline

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 2021: From the Editor

No matter what topic you delve into these days in the biopharmaceutical industry — e.g., process development, market projections, equipment scaling, quality control, regulatory harmonization — you’ll find a tangled web. Development of vaccines and therapeutics for prevention and treatment of COVID-19 continues to play out against the backdrop of unrelated products in development and others already on the market as short-term manufacturing needs and diversions of contract capacity shift the industry’s focus. This issue provides only a snapshot of…

Risk Considerations for Aging Pharmaceutical Facility Cleanrooms

Pharmaceutical facility cleanrooms are designed to reduce and control particle contamination and to minimize the ingress and retention of microorganisms. Such risks typically are easy to control in well-designed, modern facilities. But risk mitigation is more difficult in older facilities. There is no exact definition of what constitutes an aging facility (or what are sometimes euphemistically called legacy facilities). For example, a facility established 100 years ago to manufacture a simple tablet can continue to operate perfectly well with careful…

Total Global Capacity Finally Shows Improved Productivity

Since 2018, global bioprocessing capacity has grown from 16.5 million liters (1) to 17.4 million liters. Although output has continued to expand at around 12% overall, that rate represents a significant slowing in capacity growth as the industry moves toward greater productivity and efficiency. Trends that we have tracked in the BioPlan Associates annual report of biopharmaceutical manufacturing capacity and production (2) for over 17 years correlate with that finding. Titers are increasing; single-use technologies have reduced the need for…

Facilities Roundup: What’s Behind the Expansions?

In the early 2000s, the trade press was abuzz about an imminent “capacity crunch” in mammalian cell culture. Dire predictions of shortages were based on biopharmaceutical successes to that point, on bursting development pipelines, and on the lengthy timelines and high costs of assembling tens of thousands of liters of stainless-steel bioreactors and supporting infrastructure. Those predictions failed to anticipate several positive developments that would render doom-and-gloom scenarios moot. Notably, yearly improvements in protein titers for MAb processes already were…

Rapid Deployment of Manufacturing Options: An Analysis of Risks and Benefits

Biomanufacturers seeking the best approach to rapid implementation of flexible manufacturing capacity take into account the benefits presented by different modular construction options. We analyzed different approaches to building manufacturing capacity and assessed the economic benefits of each approach. Our evaluation was based on biopharmaceutical products for which there is an immediate unmet need, such as treatments or vaccinations for COVID-19. Such products also might entail a sudden increase in demand (e.g., expansion of a product indication or sales ramp…