Friday, September 20, 2019 Daily Archives

A Faster Solution to Hybridoma Screening

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Monoclonal antibodies are a rapidly growing class of therapeutics and are used in multiple clinical indications. This highly competitive landscape necessitates the need for rapidly developing next generation antibodies against new challenging targets with improved mechanism of action and pharmacokinetics. Current antibody screening tools such as ELISA, only report on binding to one antigen target at a time; hence these assays are time consuming and require large amounts of target protein. This case study highlights how the Intellicyt® iQue3 system…

September 20, 2019

Sarepta looks to PD optimization to progress DMD gene therapy

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With Brammer and Paragon contracts, Sarepta Therapeutics has ample gene therapy manufacturing capacity but says it is now working on analytical and process development yield optimization. In 2018, Sarepta announced it was adopting a “hybrid manufacturing†approach to its gene therapy pipeline meaning it would build internal expertise in adeno-associated virus (AAV)-based manufacturing while partnering with contract manufacturers. As such, the firm entered into a long-term partnership with Brammer Bio – now part of Thermo Fisher – and Paragon Bioservices…

September 20, 2019

Pfizer adds $19m plant in NC clinical gene therapy shake-up

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Pfizer will relocate clinical manufacturing activities from its Chapel Hill site to a newly acquired facility nearby in the latest ramp up of its North Carolina gene therapy capabilities. This week, big biopharma firm Pfizer acquired a piece of land and newly constructed building at 1219 Shiloh Glenn Drive, North Carolina – about 2 miles west of Raleigh-Durham International airport – set to become a center of clinical manufacturing for its gene therapy programs. Pfizer confirmed the news first broken…

September 20, 2019

China laws settle CDMO status but leave regulator lacking capacity for oversight

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New GMP and licensing laws will reshape biopharma contracting in China. But exactly what the sector will look like will depend on how they are implemented and enforced by the country’s regulator, says an expert. The Chinese National People’s Congress passed final amendments to the country’s Drug Administration Law (DAL) on August 26. The law introduces a suite of measures, including a marketing authorisation holder (MAH) system similar to those in place in the US and EU. It also reforms…

September 20, 2019