Monday, June 13, 2022 Daily Archives

Understand viral titer and quality

The cell and gene therapy field has burgeoned in the last decade with drug candidate treatments for many different diseases. Determining the correct patient dosage has become more important than ever to extend the reach of the multi-million-dollar manufacturing runs required to generate these viral therapies. Genome copies (GC), capsids, GC/capsid ratios, percent full, functional titering… What does it all mean? As of today, there is no single perfect method for capturing the qualities of viral therapies. Thus, manufacturers often…

Multisite manufacturing may not be ideal for cell therapy trials, study says

Cell therapy developers must think carefully before adopting a decentralized manufacturing model say researchers, who suggest the benefits of bedside production are outweighed by technical challenges. The advice, presented in a study in the Journal of Translational Medicine, is based on an assessment of current cell therapy production models which found that the decentralized, multi-production site approach is gaining in popularity, particularly in trials. “For cellular therapy clinical trials involving multiple sites some people are advocating a decentralized model of…

Sandoz roadmap aims to up biosimilar use 30% by 2030

The 12 goals within Sandoz’ Act4Biosimilars initiative hope to increase the global adoption of biosimilars by at least 30% in over 30 countries by 2030. Novartis’s Sandoz division is a pioneer in the biosimilars space, being the first company to receive approval of a biosimilar in the US through Zarxio, a version of Amgen’s Neupogen(filgrastim), in 2015. It has also been an advocate of these medicines, which have the potential to reduce the cost of medicine for patients and payors.…

Cambridge Pharma opens UK fill-finish facility

Cambridge Pharma has opened a plant in the Cambridge Research Park, UK, which includes a 20,000 square-foot fill-finish facility. The facility, of which financial details have not been disclosed, also includes a process development laboratory an analytical laboratory and will deliver process development, sterile fill-finish for clinical trials, stability testing and release of clinical trial materials. Cambridge Pharma is a part of SMC, a contract manufacturer of single use and disposable medical devices. The firm claims that its fill-finish facility…

BPI Europe: three minutes, three Danaher tech platforms

Physical events are back with a bang and BioProcess Insider took to the exhibition floor to speak to Cytiva and Pall about their newest technologies. Technology launches have mostly been virtual over the past two years because of the COVID-19 pandemic. But as we return to standard procedure, Sushma Nayak Teichert, global product manager at Cytiva, Ignatius Gyepi-Garbrah, global product manager at Pall, and Edina Payer technical application scientist at Pall took us through what their technology does and the problems it aims…

Curia and Replicate partner to create srRNA platform

Curia will collaborate on a development platform for Replicate Bioscience’s self-replicating RNA (srRNA) therapeutics. The collaboration sees contract development manufacturing organization (CDMO) Curia, formerly known as AMRI, and Replicate, a firm that focuses on developing ways to prevent drug resistance in cancer and to treat inflammatory and autoimmune disorders using srRNA unite to co-develop a platform. Under the terms of the collaboration, Curia’s process development team will support the production of Replicate’s srRNA vectors up to 8 L, which can…