Tuesday, April 4, 2023 Daily Archives

Advances in Bioanalytical Tools for the Characterization of In-Process Viral Samples

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This webcast features: Sofia B. Carvalho, PhD, Senior Research Associate, iBET. The expanding landscape of viruses and virus-like particles (VLPs) holds great promise for the development of safe and effective vaccines for a wide range of diseases. To keep up with the bioprocess progress requirements and growing regulatory constraints, it is critical to improve high-throughput in-process product quality control and vaccine manufacturing monitoring. There is a current need for novel and robust analytical tools in this area. iBET has a…

April 4, 2023

Thermo Fisher closing NJ cell therapy site, 113 jobs to go

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Less than three years after Thermo Fisher launched cell therapy services, the CDMO is closing its Princeton, New Jersey facility citing changing manufacturing demands. In 2020, Thermo Fisher expanded into the cell therapy space through the creation of a collaboration center in Princeton, New Jersey as part of a wider $475 million investment in its contract development and manufacturing organization (CDMO) capacity. However, the site is set to close its doors in the coming months, the company has confirmed. “Thermo…

April 4, 2023

BioNTech steps into ADC space with $170m payout to DualityBio

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BioNTech will receive the licenses from Duality Biologics for two investigational antibody-drug conjugate (ADC) assets, which aim to treat various cancers. BioNTech became a household name through its second collaboration with Pfizer after the success of BNT162b2 (Comirnaty), which was the first messenger RNA (mRNA) COVID-19 vaccine to receive emergency use approval in December 2020. However, the Germany-based firm his looked beyond mRNA as its dominant modality and has invested in cell therapies, and various antibodies, but BioNTech has not tapped…

April 4, 2023

Bioprocesses at risk from proposed ‘forever chemicals’ regulations

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Experts are calling on industry to respond to proposed rules restricting perfluoropolymers – commonly considered ‘forever chemicals’ – which are used in virtually all biomanufacturing processes. The European Chemicals Agency (ECHA) is looking to implement a series of restrictions on the manufacture, placing on the market, and use of per- and polyfluoroalkyl substances (PFAS). Multiple other jurisdictions are also proposing similar restrictions. “Virtually all bioprocesses for biotherapeutics and vaccine manufacturing depend somewhere in the process on these materials, which include…

April 4, 2023

UK Gov sets up £10m CGT manufacturing center

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The National Health Service has opened a £10 ($12.5) million cell and gene therapy manufacturing plant in Bristol that will increase UK capacity for plasmids and vectors. The Government-funded Clinical Biotechnology Centre (CBC) is designed to expand the UK’s ability to make the clinical grade products required for the research and development of new cell and gene therapies. The center will manufacture both plasmids and viral vectors. It will support early phase clinical trials and pre-clinical work. In time, the…

April 4, 2023