Author Archives: BPI Staff

Yposkesi launches LentiSure™, LV vector production platform optimized for higher yields

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New lentiviral (LV) platform provides CAR-T developers with more robust capacity to drive clinical development and commercial cell and gene therapy pipelines. Evry-Courcouronnes (near Paris), France, April 2023 – Yposkesi, SK pharmteco’s clinical and commercial viral vector manufacturing arm for cell and gene therapies, today announces the launch of LentiSure™, an optimized Lentiviral (LV) Vector manufacturing platform for increasing lentivirus production efficiency and robustness. Lentivirus or LV vectors are used to produce cell-based immuno-oncology therapies. Their robustness as a gene…

May 11, 2023

IDT Biologika on the major role of oncolytic viruses in CGT development

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IDT Biologika is a globally operating biopharmaceutical CDMO that specializes in the Contract Development and Manufacturing of cell & gene therapeutics including oncolytic viruses and viral vectors, and innovative vaccines. Through the utilization of our innovative technologies, we help our clients to advance their prophylactic and therapeutic products to treat serious diseases that impact human health worldwide. Learn more how IDT Biologika can advance your Cell & Gene Therapy projects by the following two articles: Bringing vector-based products to market…

March 31, 2023

Comprehensive Cell and Gene Therapy Testing Capabilities

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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,…

December 6, 2022

Testing times: WuXi ATU investments ready to support CGT cascade

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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…

October 4, 2022

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

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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…

September 26, 2022

#ATE22: The European CGT landscape in Tweets

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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…

September 6, 2022

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

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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…

August 26, 2022

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

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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…

August 24, 2022

Solvias boosts CGT testing with Cergentis acquisition

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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.…

July 14, 2022

Understand viral titer and quality

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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…

June 13, 2022