End-To-End Manufacturing and Downstream Bioprocessing
Upstream Bioprocessing Optimisation and Support for Early Development
Reducing Timelines with Innovative Scale Up and Scale Out Technologies
Achieving Operational Excellence in Cell and Gene Therapy Manufacturing
Key Considerations in Cell and Gene Therapy Manufacturing – CMC, Process and Regulatory

End-To-End Manufacturing and Downstream Bioprocessing

27 Jan 2022
Wacker Chemie
Comecer S.p.A

15:30 Chairperson’s Opening
Robert Speziale, Managing Director Speziale Consulting Services

 15:35 How to Develop and Leverage an Integrated Manufacturing Process and Platform to Increase Speed to Clinic

  • At Homology Medicines, we have increased our speed to the clinic by implementing a “plug and play” internal commercial GMP manufacturing process and platform designed to deliver transformative genetic medicines in vivo through multiple modalities, including different approaches to gene therapy and nuclease-free gene editing, across a broad range of genetic disorders
  • Formation of the platform was accomplished by early investment in internal Process Development and Manufacturing with methodical Research collaboration on construct design.   The platform can deliver a high degree of product quality on a consistent basis
  • Using the platform process allowed for robust manufacturing up to 2,000L bioreactor scale by limiting differences in process step execution and associated analytics across pipeline candidates; we now have 3,500L of active capacity

Michael Mercaldi, Senior Director, Downstream Process Development, Homology Medicines

15:50 The Microbial CDMO for Advanced Therapeutics

  • Wacker Biotech is the microbial CDMO – your all-in-one partner of choice for GMP contract manufacturing of therapeutic proteins, vaccines, live microbial products and plasmid DNA
  • For each of these products Wacker offers outstanding microbial technologies enabling the production at highest quality standards, with boosted yields and reduced cost of goods

Peter Danforth, Business Development Manager, Wacker Biotech GmbH

16:05 Closing The Gaps Between Preclinical Vector Supply, Process Development and GMP Manufacturing

  • In house manufacturing of gene therapy vectors for preclinical studies
  • Process development and analytical development for AAV vectors
  • Building GMP capabilities

Eduard Ayuso, Chief Technology Officer, DINAQOR

16:20 Filing Options For Shorter Time to Market of C&G Applications

  • Time to market is an essential requirement for quick commercialization of C&G processes
  • Flexibility and modularity help to adapt manufacturing to different processing needs in all process phases
  • A successful combination of processing and filling is a key step for being ready for market approval

Ken Rando, Business Development Manager, Cell and Gene Therapy (ATMPs), Comecer

16:35 Speaker Q&A and Panel Discussion


Robert Speziale
Managing Director, Speziale Consulting Services
Michael Mercaldi
Senior Director, Downstream Process Development
Homology Medicines
Peter Danforth
Business Development Manager
Wacker Chemie
Eduard Ayuso
Chief Technology Officer
Ken Rando
Business Development Manager
Comecer S.p.A