The systems are designed for the manufacture of oncology products and to research new biotech products.
The Technology Centre for Barrier Isolation Systems of Telstar, based in the UK, has developed two high-containment barrier systems for Komipharm Pharmaceuticals, a Korean producer of oncology products and veterinary medicines supplying the Asian market. Komipharm will use these systems, one for API sampling and the other for QC sample handling in its new facility in Cheongwon, Chungcheongbuk-do, South Korea.
The systems have been designed to provide a high level of containment to protect operators working with hazardous products during the manufacturing process of highly potent APIs. These systems will also be used in the development of vaccines by genetic technology. The containment systems run at negative pressure to the surrounding room and provide operator and environmental protection according to the standard ISO 7 classification inside the isolator.
Source: Telstar
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.