AAV Gene Therapy — Optimizing Scale-Up to 2,000 L in Upstream Processing

Life Sciences, Pharma, Pharma Manufacturing & Supply Chain, Cell and Gene Therapy,
  • Friday, March 31, 2023

Join this webinar to examine scale-up optimizations of AAV gene therapy in upstream processing. The featured speaker will explore both process characterization and experimental approaches to better understand key process steps, such as mixing dynamics and transfection cocktail maturation kinetics. Optimization knowledge is introduced into the process to improve yield and recovery at the 2,000 L scale.

Viralgen specializes in the large-scale cGMP production of AAV gene therapy vectors using their proprietary suspension, triple transfection platform. This platform includes the Pro10™ animal origin free and suspension-adapted cell line, a scalable upstream and robust purification process, coupled with full support for fill and finish, QC testing and regulatory guidance from preclinical to commercial requirements.

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Speaker

Silvia Gomez, Viralgen

Silvia Gomez, PhD, MSAT Head, Viralgen

Silvia Gomez currently works at Viralgen Commercial Therapeutic Vector Core as MSAT Head, responsible for technology transfer, scale up to 2000L and handling deviation from GMP batches. Silvia has eight years of prior experience in molecular biology and virology for basic and translational research and six years of CDMO experience at 3P Biopharmaceuticals (being responsible for technology transfer, scale-up and fill and finish in the last three years). Dr. Gomez has a degree in biochemistry and PhD in biomedical research.

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Who Should Attend?

Therapeutic developers using AAV in the manufacture of cell and gene therapies

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Viralgen

Viralgen

Viralgen, an independently operated Contract Development and Manufacturing Organization (CDMO), was founded in 2017 as a joint venture between AskBio and Columbus Venture Partners (a venture capital firm based in Spain). As one of the world’s leading manufacturers of cGMP-certified AAV, Viralgen uses the Pro10™ based suspension manufacturing platform, a technology licensed from AskBio and developed by co-founder R. Jude Samulski, PhD, at University of North Carolina. Pro10™ increases scalability, performance and precision of AAV therapies. Located in Spain, in the Gipuzkoa Science and Technology Park, Viralgen produces AAV gene therapy treatments for pharmaceutical and biotech companies with the aim of accelerating the delivery of new treatments that can improve patients’ lives.

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The company’s clinical facilities have four cGMP manufacturing suites, with 250-liter and 500-liter bioreactors. In 2020, Viralgen expanded within the Scientific Park by constructing a new building for increased manufacturing capacity which recently received Current Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products, and sterile or biological active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), a part of the European Medicines Agency (EMA) network. The company now operates two facilities in San Sebastian, Spain, with seven state-of-the-art single-use suites that have up to 2,000 liters of manufacturing capacity, making it a world-leading contract development and manufacturing organization (CDMO).

Viralgen has more than 420 employees, with three quarters of these holding advanced degrees. This talented workforce supports a range of core capabilities in quality assurance, quality control, analytical development and process development, all of which are critical to shortening the time to market and supporting customers with the regulatory process.

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