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Downstream AAV Production: A Targeted Approach to Optimization

This webinar will highlight our multifaceted approach to downstream purification including separation of genome containing (full) from genome-free (empty) AAV capsids and a selection of innovative purification solutions to improve yield, purity and throughput. 

View on demand. 

Key messages:

  • The key parameters to consider for optimizing AAV purification: Serotype, Upstream harvest yields, Empty:Full ratios, recovery and our approach to purification
  • Showcase our selection of DSP purification techniques in our toolbox 
  • Platform improvements to be aligned with the latest technological advancements and driven through both external collaborations and internal innovation
  • Use of BIA Separations’ monoliths as a solution to the challenge of separating full from empty AAV capsids
  • Use of BIA Separations’ new CIMasphere technology for the removal of host cell DNA related impurities

Agenda: 

  1. What is the current industry wide understanding on separating Empty:full capsids? 
    • The key parameters for consideration (including regulatory stance) and why they are so important
    • Difference in purification methods (based on serotype) and their scalability (UC, chromo)
    • Product specific impurity removal
  2. What is our current approach to DSP purification
    • Platform process and data to assess fit
    • High-throughput technology in combination with DoE to optimise key parameters and increase pace 
    • Impact of resin low resolution between empty and full capsids 
    • Introduce BIA and importance of collaboration
  3. What is BIA Separations monolith and CIMasphere technology and how to use them for purification of clinical-quality AAVs? 
    • Introduction to BIA Separations and their products
      • Use of monoliths in gene therapy commercial manufacturing 
      • Monolith architecture for preparative and analytical applications 
      • What makes monoliths suited to the challenging requirements of purifying large biomolecules such as AAVs? 
      • Chromatin’s effect on AAV purification and how the CIMasphere technology may help
    • Pharmaron's Feasibility study and optimisation data 
      • Optimization study to tune running conditions for cation and anion monolithic purification
      • CIMasphere feasibility study to benchmark BIA Separations’ cornerstone platform for purification of AAVs

View on demand. 

Moderated by: Linda Randall - Associate Vice President Biologics Development, Manufacturing and Control at Pharmaron Gene Therapy

Key Opinion Leader: Gary Potter - Senior VP, Global Operations at ASC Therapeutics

Gary Potter has recently joined ASC therapeutics as Senior Vice President, Global Operations and leads the teams responsible for drug substance and drug product process development, manufacturing, and supply chain for gene and cell therapies required for all phases of clinical development and commercialisation. He graduated from Hamline University, in St Paul, Minnesota with a degree in Biology and has a B.A. degree. Prior to joining ASC Therapeutics, he served at uniQure Inc. as Vice President of Operations, producing next-generation gene therapy factor IX for hemophilia B. With over 30 years of industry experience, including leadership roles at Newlink Genetics, Cell Genesys, Amgen, Abgenix and Baxter, he has expertise in cell culture manufacturing, gene therapy facility design, technology transfer, GMP facility operations, and commercial readiness.

Speakers: 

Spyridon GerontasSenior Technical Specialist, Process Sciences, Pharmaron Gene Therapy

Spyros is a Senior Technical Specialist in Process Sciences at Pharmaron Gene Therapy, Liverpool. In his role, he leads the bioprocessing development of gene therapy products in Pharmaron’s cutting-edge facilities. Furthermore, he promotes the implementation of innovative technologies in gene therapy downstream processing through strategic technology partnerships in order that Pharmaron gains/maintains a competitive edge. Moreover, he leads the scale-up and tech transfer of DSP platforms for viral vectors and recombinant proteins to Pharmaron’s strategic partners. Spyros holds a PhD in Biochemical Engineering from University College London (UCL) and an M.Sc. from the National Technical University of Athens. After completing his PhD studies, he continued his research as a postdoctoral Research Associate in the Department of Biochemical Engineering at UCL. Prior to joining Pharmaron, he worked as team leader for method development in downstream processing and analytics at an R&D company in Berlin, Germany.

Hana JugProject Manager in Process Development for Viral Vectors & Vaccines at BIA Separations

Hana Jug is a Project Manager in Process Development for Viral Vectors & Vaccines at BIA Separations, a Sartorius company. She studied molecular biology at the University of Ljubljana and graduated in 2012. The same year, she started working at BIA Separations as a Researcher. She has many years of experience in downstream purification and analytics of demanding biologics such as different viruses and plasmids. Hana has managed several projects for clients in clinical phases, mainly in the field of gene therapy using adeno-associated virus, as well as in the vaccines area, with Adenovirus platforms. She is responsible for biosafety at BIA Separations, which includes training of employees and preparation of risk assessments. Hana enjoys working with biological agents and finding optimal purification solutions for the customer while also ensuring a good level of biosafety among employees.

 

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