12-15 November, 2018
Marriott Marquis & Marina, San Diego, CA

Post-conference workshops

AM | Thursday November 15

 

Workshop G Workshop H:
Plunging into a World of
Developing Robust & Scalable Processes for Clinical Manufacturing
Modularity & Flexibility
for Aseptic Processing for ADCs. From Batches for Clinical Trials to Commercial Production
08.00 – 11.00 08.00 – 11.00am
The complexity of ADCs means developing robust and scalable manufacturing processes can be very challenging.
As antibody drug conjugates (ADCs) move through clinical development, from phase 1 to pivotal studies, supported by clinical efficacy and appropriate safety, the development of late stage and commercial-ready processes and methods becomes a priority.Workshop Leader: To be confirmed
Sterile fill finish for ADCs or other biological
pharmaceutical products are the final dose
for the treatment of the patient. This could be
during clinical trials or later for commercial
production. The workshop will explain how
sterile fill finish could be applied even for
small start up companies to produce their first
clinical batches by themselves and enlarge
the installation later with additional modules
to launch their product with the
VarioSys-Technology.Workshop Leaders:
Richard Denk, Head, Sales Containment, SKAN
Armin Storz, Sales Manager, Bausch&Stroebel

PM | Thursday November 15

Workshop K Workshop J:
Scale Up, Outsourcing &
Managing Complex Supply Chains
Improve Manufacturing
Quality Controls
12.00 – 15.00 pm 12.00 – 15.00 pm
In an environment of limited capacity for
manufacturing, decisions must be made
early on in consideration of how to source
different components of the ADC supply
chain. This workshop will explore the key
criteria for successful clinical and commercial manufacturing of ADCs. It will also touch upon developing reliable cold shipping lanes.Workshop Leader: Brian Clark, Principal Consultant, GMP Operations Consulting
ADCs are viewed by regulatory agencies as
both drug and biological molecules which
adds a layer of complexity for characterization, manufacturing process controls, comparability, release, and stability assays. Attend this workshop to improve your manufacturing quality controls and meet the appropriate
regulatory requirements for the entire ADC molecule.Workshop Leader: Ahmed Bassyouni, Independent Consultant