Author Archives: BPI Staff

Comprehensive Cell and Gene Therapy Testing Capabilities

With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, Advanced Therapy Medicinal Products (ATMP), such as gene and cell therapy products, are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional biopharmaceutical products, especially when it comes to the use of these products for personalized medicine. The complexities span the development pipeline,…

Testing times: WuXi ATU investments ready to support CGT cascade

WuXi Advanced Therapies has highlighted its expanded cell and gene therapy testing capabilities in preparation for as many as 200 products reaching the market in the next seven years. “Just 18 months ago there was a little over 1,100 compounds in development. Now there are over 2,000,” Michael Stump, executive director of Testing Operations at WuXi Advanced Therapies said at Biotech Week Boston. “Even a 5-10% success rate, we’re looking at 200 modalities coming into the market in the next…

CDMOs: ‘Invest in bio capacity now to meet surging demand over next 5 years’

With new targets coming from smaller biotech, there are huge opportunities for contract manufacturers that can invest today in anticipation of the demand tomorrow, says GlobalData. Ahead of his presentation at Connect to Frankfurt (opening September 28th) – a new digital platform accompanying CPHI Worldwide in Frankfurt, Germany – BioProcess Insider spoke with Quentin Horgan, associate director, Pharmaceutical Data & Analytics at analytics and consultancy firm GlobalData.   He looks ahead to what are likely to be the biggest selling…

#ATE22: The European CGT landscape in Tweets

Advanced Therapies Europe (#ATE22) took place in London, UK, last week. BioProcess Insider was there, as were biopharma’s social media army. We present the best from the Twittersphere.   Before we consider and celebrate #CGT in a #EuropeanMarket at out #AdvancedTherapiesEurope event next month, take a look at this handy infographic with 5 Disruptive Strategies for Market & Patient Access in Europe. Do you agree with them? Take a look 👇https://t.co/EvBfHAFRvs — Phacilitate (@Phacilitate) July 13, 2022 Honoured to be…

How Our Partnerships Move Your Life-Changing Biologics to Market: Two Case Studies

Muctarr Sesay, chief scientific officer, Goodwin Biotechnology. Goodwin Biotechnology’s mission is to minimize manufacturing risks associated with complex biopharmaceuticals, including antibody–drug conjugates (ADCs), bioconjugated vaccines, and multispecific antibodies. Sesay described his company’s capabilities, which span from preclinical process development through commercial supply. Currently, the Goodwin site in Fort Lauderdale, FL, is equipped for 200-L and 500-L bioreactors in both stainless-steel and single-use formats. The company can perform drug substance and drug product manufacturing as well as fill–finish steps, all according…

Crossing the Finish Line: Preparing for and Passing a Preapproval Inspection

Ray Marzouk, vice president of quality, Avid Bioservices. Since Avid’s first commercial approval in 2005, the company has been inspected multiple times by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Brazilian Health Regulatory Agency, and Health Canada. Avid makes drug substance for products that are approved and marketed in more than 90 countries. The company has succeeded in eight preapproval inspections (PAIs), the most recent five of which had no 483 observations. PAIs differ…

Solvias boosts CGT testing with Cergentis acquisition

Contract development firm Solvias has bought gene sequencing firm Cergentis to feed the expected growth in cell and gene therapy testing demand. The deal, financials of which have not been divulged, will see Swiss pharmaceutical testing and manufacturing firm Solvias absorb Utrecht, Netherlands-based Cergentis, bolstering its biologics and cell and gene therapy (CGT) testing solutions. Cergentis uses its genomic analysis platform for the characterization and QC of genetically engineered models, biopharmaceutical cell line development, and cell and gene therapy products.…

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…

Bristol-Myers forks out $4.1bn to acquire Turning Point Therapeutics

Bristol-Myers Squibb will acquire oncology firm Turning Point Therapeutics for 4.1 billion and gains its lead asset, repotrectinib aiming to treat lung cancer and solid tumors. The merger agreement will see Bristol-Myers Squibb (BMS) pay $76.00 per share to acquire Turning Point Therapeutics (TPT) and the deal is expected to close during the third quarter of this year. As part of the deal, BMS will take on TPTs lead asset, repotrectinib, a next generation tyrosine kinase inhibitor (TKI) targeting ROS1…

Aseptic closed small-volume processing: Today’s options

Small-volume biopharmaceutical processes continue to grow as more biopharmaceutical, cell therapy and gene therapy companies develop products. A 2021 Association for Regenerative Medicine (ARM) report states that there are 1,085 cell, gene and tissue-based therapy developers worldwide. These companies are engaged in many small-volume (<10L) processes including early-stage drug development and autologous therapies. The increase in small-volume processes coincides with the ongoing need to create fast, reliable aseptic closed systems. Historically, few convenient options have existed to facilitate sterile processing.…