october, 2015
05octallday06allday2nd Technology Transfer for Biologics
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
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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
Top Five Reasons to Attend
- In-depth examination of the proper tech transfer methods for antibody-drug conjugates, biosimilars, and other new molecules
- Case studies illustrating how to maintain product purity during upscaling
- Analysis of the best approaches for rapid technology transfer acceleration
- Review of the ideal skill sets and leadership styles of tech transfer project managers
- 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:
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This event may also be of interest to:
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Time
october 5 (Monday) - 6 (Tuesday)
Location
Merck Research Building
33 Avenue Louis Pasteur Boston MA