october, 2015

05octallday06allday2nd Technology Transfer for Biologics

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Event Details

Once you have established biologic efficacy and safety in early clinical material, your company’s real challenges are only beginning. Replicating the synthesis and bioanalysis of your biologic at different settings and among licensing or manufacturing partners introduces the risk of facility-based errors. And in order to commercialize your biologic, production volumes must be upscaled so intensely that new problems not encountered at smaller clinical volumes may severely hinder your timelines.

ExL Events’ 2nd annual Technology Transfer for Biologics conference recognizes that every instance of technology transfer succeeds or fails based on transparency of communications and the skill of the project manager. Exclusive case studies from industry leaders can help you guarantee biologic quality and accelerate to commercial stages after method transfer. No other event focuses so specifically on the essential skill sets required for team-based biologics quality assurance during and after method transfer!

“Strong content on technical requirements and challenges for method transfer, from obvious subject matter experts.” –Associate Director, External Manufacturing, SHIRE


Featured Speakers

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Top Five Reasons to Attend

  1. In-depth examination of the proper tech transfer methods for antibody-drug conjugates, biosimilars, and other new molecules
  2. Case studies illustrating how to maintain product purity during upscaling
  3. Analysis of the best approaches for rapid technology transfer acceleration
  4. Review of the ideal skill sets and leadership styles of tech transfer project managers
  5. Detailed discussion of the equipment standardization exercises and process models that safeguard biologics quality

Who Should Attend

Pharmaceutical, biotech and medical device professionals responsible for:

  • Technology Transfers
  • Method Development/Method Transfers
  • Technical Operations
  • Technical Science
  • Bioprocessing
  • Manufacturing/Biomanufacturing
  • Process Development
  • Quality Control/Quality Assurance
  • Upscaling
  • Facilities
  • CMC
  • Biologics Outsourcing
  • Biologics Strategy
  • Process Sciences
  • Upstream
  • Vendor Management/Supply Chain

This event may also be of interest to:

  • CROs
  • CMOs
  • Aseptic Fill-Finish Vendors
  • Quality Control Specialists
  • Cell Culture Suppliers/Managers
  • Central Labs
  • Regulatory Consultants
  • Supply Chain Facilitators
  • Lab Hardware Designers
  • Facility Designers

Time

october 5 (Monday) - 6 (Tuesday)

Location

Merck Research Building

33 Avenue Louis Pasteur Boston MA

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