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A promotional graphic for a CGT webinar series by Pharmaron, titled "Downstream AAV Production: A Targeted Approach to Optimization." Featured speakers include Gary Potter, Spyridon Gerontas, and Hana Jug, each with their titles and affiliations listed. Discover insights into preclinical ADME studies.

Capabilities

Product Characterization and QC Analytics

Recorded: March 2022

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

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Key messages on Downstream AAV Production:

The key parameters to consider for optimizing downstream AAV production and 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:

What is the current industry-wide understanding of separating Empty and full capsids?
- The key parameters for consideration (including regulatory stance) and why they are so important
- Differences in purification methods (based on serotype) and their scalability (UC, chromo)
- Product-specific impurity removal
What is our current approach to DSP purification?
- Platform process and data to assess fit
- High-throughput technology in combination with DoE to optimize key parameters and increase pace
- Impact of resin low resolution between empty and full capsids
- Introduce BIA and the importance of collaboration
What are BIA Separations monolith and CIMasphere technology, and how can we purify 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 optimization 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

Meet our Speakers

Key Opinion Leader:

Gary Potter – Senior VP, Global Operations at ASC Therapeutics

Gary Potter has recently joined ASC Therapeutics as Senior Vice President of 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 commercialization. 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 Gerontas – Senior 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 for Pharmaron to gain/maintain 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 Jug – Project 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.

Downstream AAV Production: A Targeted Approach to Optimization