Key highlights include:
Cyclo Olefin Polymer (COP) technical data update
– Key properties of COP
– Case study. Biologics formulation for COP syringe optimized to eliminating
use of surfactant
– Case study. Study on protein adsorption/aggregation COP vs glass
– Case study. Study on delamination with glass syringe vs COP syringe
– Leachable data on COP syringes with various chemicals
Keynote Address
Control strategy and design transfer for pharmaceutical delivery device combination products
– Establish control strategy (CS) for PFS manufacturing including device constituent parts
– Develop CS for delivery device during design transfers to identify critical quality attributes (CQAs) for device constituent parts
– Generate a set of controls, e.g. incoming, in-process, release and/or stability specifications for delivery device manufacturing
– Promote communication between device and drug development groups, development and manufacturing groups, pharma company and device component suppliers
– Recognize the difference between delivery device and drug: drug focused more on process parameter (e.g. CPP) and device focused more on material attributes (e.g. CMA)
The best plastic syringe for biologics
– Multilayer plastic vial & syringe
– Excellent oxygen and UV barrier contribute to stability of drugs
– Very low extractables contribute to stability of drugs
– Minimized silicone-oil contributes to preventing protein aggregation
PFS / autoinjector compatibility impacts to manufacturing and drug delivery performance
– What is the PFS/Autoinjector compatibility?
– Challenges to manufacturing and drug delivery performance
– Proposed solutions
Speakers include:
Toshiro Katayama, Product Manager, Zeon
Ling Lu, Sr. Principal Scientist, Pfizer
Shota Arakawa, Business Development Researcher, Mitsubishi Gas Chemical Company
Joyce Y Zhao, Device Lead, Combination Product Development, Takeda
More details are available at the website http://www.pfsamericas.com/pr5
Sponsored by:
3P Innovation | Aptar Pharma | CSS (Connecticut Spring & Stamping) | Harro Höfliger | Lonstroff | Mitsubishi Gas Chemical | Owen Mumford | Polyplastics | RheoSense| Schott | Steri-Tek | Sumitomo Rubber Industries | West Pharmaceutical Services | Zeon
Contacts:
Sponsorship, exhibition and branding packages: Alia Malick +44 (0)20 7827 6168 / amalick@smi-online.co.uk
Delegate enquiries: Kieran Ronaldson on +44 (0) 20 7827 6744 / kronadlson@smi-online.co.uk
Media enquiries contact Neill Howard +44 (0) 207 827 6164 nhoward@smi-online.co.uk
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