Small biotechs in early development of cell therapies are often surprised by the strictness of commercial manufacturing standards. That’s the view of Luděk Sojka, PhD, CEO of contract developer and ...

Exogenus Therapeutics and Lonza agreed to collaborate on the development of Exo-101, Exogenus’ exosome-based lead candidate. The company specializes in the development of therapeutics based on ...

Discover proven strategies and innovative technologies to streamline microbial development, from early studies to GMP readiness. Learn from industry experts how to boost productivity, overcome ...

Main opportunities include integrating process validation with modern, science-based approaches, utilizing risk-based strategies like QbD, DOE, and PAT, and adhering to global regulatory standards to ...

This white paper explains the benefits and challenges of microbial-based fermentation for biologics, highlighting why processes often need to be custom-built for each molecule. Outlining a streamlined ...

Vaccizone has selected Exothera S.A. to fast-track process development of its SARS CoV 2 vaccine for European clinical trials. Vaccizone has developed and patented a novel method for delivering ...

The rise in novel, more potent compounds, alongside EU Annex 1, are mounting pressure on biopharma, CDMOs and equipment providers to evolve their industrial hygiene, process engineering and ...

LineaRx will present its Linea™ IVT platform - a combination of an enzymatically produced DNA template (Linea™ DNA IVT template) coupled with a next-generation RNA polymerase (Linea™ RNAP) - as a ...