Wednesday, June 14, 2023 Daily Archives

Regulatory role of Biophysics in Biologics CMC

by

Biophysics-driven understanding of higher order structures (HOS) and corresponding critical quality attributes (CQA) are imperative for drug regulation. HOS modulates the functional repertoire of biologics which mainly comprises proteins. On the other hand, critical quality attributes (CQAs) are the physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to achieve the intended product quality (Source: ICH Q8 R2). CQAs typically relate to the drug component’s excipients, intermediates (materials in the process),…

June 14, 2023

Flexibility key to keeping up with CGT’s changing tech needs, CBM

by

The Center for Breakthrough Medicine (CBM) says flexibility, space, and trained staff are necessary to keep up with technological progess in the advanced therapy space. With the science of advanced therapies proven and industry bracing for another year of cutting-edge approvals, it is no surprise the technology in the space is also evolving. Thus, with a rapidly changing landscape, there is a need for adaptability. “There is not one definition of what advanced therapies are,” said Avi Nandi, chief technology officer…

June 14, 2023

Mentorship key to embedding DE&I into company culture, CGT expert

by

“We want to see women ascending leadership positions and that will be our metric of success,” says Lara Silverman, principal consultant at LIS BioConsulting on the latest Voices of Biotech podcast. In the latest Voices of Biotech podcast, brought to you by the BioProcess Insider Expression Platform, Lara Silverman sheds some light on career paths, mentorship, and taking ownership of your own development. Silverman discusses DE&I in the cell and gene therapy space, emphasising the goal is to get to…

June 14, 2023

Ferring gets FDA approval of scale-up process for bladder cancer gene therapy

by

The US FDA has granted Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS)  to scale-up the manufacturing process for gene therapy Adstiladrin (nadofaragene firadenovec) in Finland. In December 2022, the US Food and Drug Administration (FDA) approved Ferring’s adenovirus vector-based gene therapy Adstiladrin, an intravesical therapy administered to the patient at three-month intervals. The therapy is used to treat adults with high-risk Bascillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) that works by targeting the individuals’ bladder wall cells to boost the body’s…

June 14, 2023

CGT CDMO roundup: News from CRL, NorthX, and Avirmax

by

Charles River signs two gene therapy deals, NorthX inks cell therapy manufacturing deal with Mendus, and Avirmax has opened a gene therapy facility in California. Welcome to our CGT focused CDMO roundup. First up in our contract development and manufacturing organization (CDMO) roundup is Charles River Laboratories (CRL). The firm has signed a deal with Korean biotechnology company Curigin to manufacture adenoviral vectors. Curigin, a firm focused on developing oncolytic ribonucleic acid interference (RNAi) gene therapies, will use CRL’s CDMO…

June 14, 2023

Catalent lays out plan to bring biologics biz back to brilliance

by

Catalent attributed a 32% year-on-year drop in biologics sales in its postponed third quarter to the COVID-cliff and productivity issues but remains confident it can bring the division “back where it needs to be.” Catalent had twice postponed its fiscal year third quarter results before this week’s financials were finally published, with the contract development and manufacturing organization (CDMO) citing forecasting issues and “productivity issues and higher-than-expected costs.” But despite the company’s woes, the financials were better than expected, causing…

June 14, 2023