The determination of total capsid titer is one of the critical quality attributes for AAVs used in gene therapy. This application note presents quantitation of AAV serotype 2, 5, 8 and 9 using GatorPrime™ system and Gator™ AAVX probes, and compares the performance with Progen Xpress ELISA assay for the same serotypes. The Progen ELISA kit is commonly used for AAV quantitation and while it performs well, it has several drawbacks for routine operation, viz, need to dilute the samples…
This webcast features: Kathleen Kenney, Associate Director, Viral Clearance, WuXi Advanced Therapies, R. Christopher Manzari, Manager, Viral Clearance – DSP/Virus Production, WuXi Advanced Therapies. Join us for a discussion on the risk-based approach in the development of Viral Validation studies, a key testing requirement for regulatory submissions of viral vector-based therapeutics, at WuXi Advanced Therapies. In this webinar, members of the Viral Clearance Management team will cover the basics of viral clearance, study development and the general timeline. Collaboration between…
The partnership will see Code Bio’s 3DNA platform used to design and develop gene therapies for rare disease indications. Under the terms of the deal, Takeda will use Code Biotherapeutics’ (Code Bio’s) non-viral 3DNA platform to target a liver-directed rare disease program and central nervous system conditions across a total of four programs. “3DNA is a synthetically made DNA that can be used as a targeted vehicle to deliver therapies. We have a proprietary process to attach therapeutic payloads and…
BioProcess Insider had the pleasure of figuratively sitting down with Catalent’s chief operating officer Alessandro Maselli who is set to succeed John Chiminski as CEO effective July 1, 2022. If you know anything about the contract development manufacturing organization (CDMO) space, you know about John Chiminski. He joined Catalent in 2009 and has since led the firm through a period of evolution – taking it from a traditional softgel and small molecule service provider to a strategic partner working across…
Carsgen Therapeutics’ new facility in North Carolina is poised to begin making candidate CAR-T cell therapies for trials after passed an inspection. The facility in Research Triangle Park (RTP) – which official opened this week – was issued with a certificate of compliance after being visited from inspectors from Durham city council. Company president Richard Daly welcomed the decision as an important expansion of Carsgen’s manufacturing network. “RTP manufacturing facility plus two Carsgen existing GMP facilities in Shanghai, China will enhance our…