Tuesday, November 16, 2021 Daily Archives

eBook: Vaccines Revisited — The Past, Present, and Future of Nucleic-Acid Vaccine Production

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The quarterly BioProcess Insider eBook series launched in 2021 to investigate specific modalities and business strategies driving the biopharmaceutical sector based upon trends and discussion points presented in the Insider’s pages. Two of the four quarterly publications — this one included — have focused on the vaccine industry. If the series had launched in 2019, cell and gene therapies might have warranted a double edition, or perhaps investments in antibodies and antibody fragments would have driven a bispecific focus. Five…

November 16, 2021

A Practical Approach to Clinical Trial Diversity

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A 2021 study in the Journal of the American Medical Association found that minority groups were underrepresented in US-based vaccine clinical trials, with white people accounting for ~80% of participants (1). Although researchers broadly acknowledge that trial representation should mirror the many different populations who could benefit from a drug, lack of diversity continues to hamper clinical-trial effectiveness. To address this problem, the pharmaceutical industry must increase awareness about clinical trials and reduce barriers to participation in them. Benefits of…

November 16, 2021

Scale-Down Optimization to Scale Up Success

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As immune cell therapy advances to address new indications, the need for rapid development of robust manufacturing processes becomes increasingly important. Early process optimization sets the stage for clinical and commercial manufacturing and plays a foundational role in decreasing time to market and lowering COGS. This application note describes the streamlining of T-cell expansion optimization using a DOE-based approach in a semi-automated, controlled multi-parallel setup of the Sartorius T-Cell Exploration and Characterization Solution. Download to learn about: Rapidly screening media…

November 16, 2021

Baxter injects $100m to expand German fill-finish plant

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Baxter Biopharma Solutions will invest $100 million to expand its fill-finish capabilities at a plant in Halle/Westfalen, Germany. The German facility is operated by Baxter Biopharma Solutions (BPS), the contract development manufacturing organization (CDMO) arm of Baxter International. The $100 million expansion will add a syringe filling line and additional lyophilized and liquid vial capacity. According to the firm, the addition of an aseptic syringe filling line will enable BPS to meet the increased demand for fill-finish services in Europe…

November 16, 2021

CGT Catapult partners to overcome barriers in ATMP industry

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CGT Catapult has partnered with Deep Science Ventures to tackle issues and create companies that address needs in the advanced therapy sector. Together, the Cell and Gene Therapy Catapult (CGT Catapult) and London , UK-based venture creator Deep Science Ventures (DSV) aim to drive innovation and employment opportunities in the advanced therapy industry by addressing challenges in the sector and creating companies to support better patient outcomes. “The CGT Catapult will leverage its world-class technical and regulatory expertise in ATMPs alongside…

November 16, 2021

COVID hit cell and gene therapy trials and suppliers but experts see signs of recovery

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COVID-19 disrupted cell and gene therapy trials as well as the contractors and suppliers that support them, according to experts. SARS-CoV-2, the virus that causes COVID-19, impacted all parts of biopharma. For example, the focus on vaccines highlighted manufacturing capacity limitations while increased demand for consumables and raw materials put pressure on suppliers. The pandemic also disrupted R&D to the extent that some developers put projects on hold according to Amelie Boulais, head of market entry strategy at Sartorius, who…

November 16, 2021