Conference Day One

Wednesday 30th August 2023

7:45 am
Registration & Welcome Coffee

8:45 am
Chair’s Opening Remarks

Enhancing the Stability of Viral Vectors via Next Gen Cell Line Engineering & Formulation

9:00 am Development of Capsid Engineering

Synopsis

  • Advancing capsid engineering to reduce immunogenicity
  • Maximisation of stability via engineering
  • Discussing the specifics of enhancing capsid design for AAV vectors

9:30 am Characterisation of AAVs & Other Gene Therapy Vectors Using TEM to Assess Critical Quality Attributes

  • Kara Poon Senior Scientist, Vironova BioAnalytics

Synopsis

  • Gain business-critical insights into CQAs such as morphology, purity, integrity, aggregation, size and circularity distribution, and transgene incorporation and characterisation
  • Wholistic GMP-certified TEM services for imaging and analysis of gene therapy vectors using cryoTEM and nsTEM
  • Supporting the development of novel therapies with reliable and traceable data from ultra-low sample volumes

10:00 am
Speed Networking & Morning Coffee

11:00 am Solving The Deep-Frozen Challenge: Development of a Formulation to Stabilise Oncolytic Viruses

  • Julia Sacherl Drug Product Scientist at the ‘Viral Therapeutics Center’, Boehringer Ingelheim

Synopsis

  • Development of a formulation to stabilise lypholised oncolytic viruses
  • Challenges and optimisation of the lypholisation process
  • Stability data of lypholised oncolytic virus at 2-8°C

11:30 am Ensuring Compliance through Particle Analytics & Formulation

  • Ondrej Preto Sr. Specialist - Formulation Development, Hookipa Pharma Inc.

Synopsis

  • Regulatory requirements for ATMPs
  • Increasing process robustness by control of particle formation
  • Particle analytics from bench to clinic

12:00 pm
Networking Lunch Break

Increasing Upstream Process Development Efficiency

1:00 pm The Applicability of Different Viral Vector Production Techniques

  • Pranav Puri Senior Scientist - BioProcess Development, VectorY

Synopsis

  • Comparison of the different viral vector production techniques to decide the most appropriate
  • Introduction to baculovirus system to improve scalability and cost efficiency of AAV production
  • Presenting some of VectorY’s results of increased production using the baculovirus method

1:30 pm Increasing AAV Titre via Transfection Improvement to Reduce Costs

Synopsis

  • Selecting the correct critical raw materials
  • Defining the key parameters for transient transfection productions at small scale to ensure a scalable process
  • Data presentation on the scale-up of production using a stirred tank bioreactor

2:00 pm Novel Vector Design for Enhanced Expression & Genetic Payload Capacity

Synopsis

  • Adopting advanced sequencing techniques to design your novel plasmid to maximise expression
  • Evaluate how this can impact on your viral vector performance and quality
  • Streamlining your upstream process via tightened control of plasmid and vector to regain speed

2:30 pm Developing a Future Proof Commercially Viable Lentiviral Vector Manufacturing Process

  • Sammie Whaler Senior Scientist - Manufacturing, Science & Technologies & Vector Pharmacokinetic Cell & Gene Therapy, Orchard Therapeutics

Synopsis

  • Development of a transient suspension process for commercialism
  • Downstream process strategy for large scale LVV production
  • Characterisation of the process platform

3:00 pm
Afternoon Refreshments & Poster Session

Yield Matters: Creating Robustness through Downstream Processing of Your Viral Vectors

3:45 pm Downstream Process Development & Manufacturing of Recombinant AAV

  • Marie Clincke Gene Therapy Process Sciences Innovation & Partnership Leader, UCB S.A.

Synopsis

  • Advancements in the downstream process development of UCB’s AAV candidate
  • Developments in the manufacturability of this vector to promote scalability
  • The challenges of creating a scalable rAAV product

4:15 pm Roundtable Discussion: Improvement of Downstream Efficiency to Maximize Yield

Synopsis

  •  Optimising purification recovery to maximise yield
  • Implementation of equipment to automate the purification process to increase reproducibility and yield
  • Large scale chromatography to overcome diffusion-limited beads for efficient purification

4:45 pm
Chair’s Closing Remarks

4:50 pm
Poster Session & End of Day One