Wednesday, August 25, 2021 Daily Archives

Enabling High-Performing
Perfusion Cell Culture

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At least one report estimates that by 2025, 35% of biologics will be manufactured using enhanced processes, particularly perfusion-based bioprocessing. Results of two innovations that support this need for enhanced processes are examined below. The Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor (SUB), the latest advancement in SUB technology, offers better performance than other bioreactors and scalability up to 5,000 L. Gibco High-Intensity Perfusion CHO Medium is formulated to provide exceptional performance and ease of use, with capability of sustaining >1…

August 25, 2021

eBook: Cell and Gene Therapies —
A 2021 Industry Update

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The US Food and Drug Administration (FDA) reports that as of June 2021, 22 advanced therapy products have received regulatory approval in the United States. The first such product gained regulatory approval in 2010. Since then, hundreds of cell and gene therapies have advanced to clinical evaluation, but few products have reached commercial stages — and those that have done so have been hindered by manufacturing problems. In this eBook, writers from the BioProcess Insider and Project Farma analyze trends…

August 25, 2021

The iCapTag Protein Purification Platform: Bridging Research and Manufacturing

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Purification of recombinant proteins remains a critical challenge for applications ranging from basic biological research to the development and production of lifesaving biopharmaceuticals. At laboratory scales, the rapid purification of large numbers of new and uncharacterized protein targets effectively compels the use of affinity tags, which enable reliable purification using simple, established protocols with minimal optimization. Tags cannot be used for therapeutic applications, however, because of their potential for immunogenicity. Thus, for proteins other than monoclonal antibodies (which typically use…

August 25, 2021

Sartorius and McMaster University to ‘perfect’ antibody manufacturing process

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McMaster University and Sartorius have teamed up to improve the efficiency of chromatography in the large-scale manufacture of antibody and virus-based treatments. The collaboration sees Sartorius Stedim Biotech and McMaster University in Hamilton, Canada partner to advance manufacturing processes used for antibody and virus-based treatments such as COVID-19, genetic disorders, and cancer. “Through collaboration and partnerships with universities, Sartorius drives innovation for technological breakthroughs that lead to better health for more people,†a spokesman for Sartorius said. “The current state of art in downstream…

August 25, 2021

Pfizer to acquire Trillium in $2.3bn deal

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Pfizer bolsters its oncology capabilities through the acquisition of Trillium, which it says will add investigational immuno-therapeutics for cancer. Pfizer, which invested $25 million in Trillium Therapeutics in September 2020, will acquire all outstanding shares of the immune-oncology firm in a deal worth $2.26 billion. “Pfizer is strengthening its individual therapeutic areas with capabilities and breakthrough medicines to enhance leadership positions in priority areas,†a spokesperson for Pfizer told BioProcess Insider. “The acquisition of Trillium Therapeutics strengthens Pfizer’s leadership in…

August 25, 2021

EMA thumbs up to more CDMO sites supporting COVID vaccines

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The European Medicines Agency (EMA) has approved a Delpharm plant in France and a Catalent facility in the US to support supply of Pfizer and Moderna’s COVID-19 vaccines, respectively. The approvals from the EMA’s human medicines committee (CHMP) this week aim to increase manufacturing capacity and supply of the two COVID-19 vaccines in the EU. The first saw the Agency approve a fill-finish site in Saint Remy sur Avre, France operated by contract development and manufacturing organization (CDMO) Delpharm. The…

August 25, 2021