Pre-Filled Syringes - Chemical Compatibility and Design Strategies

At SMi’s 2019 Pre-Filled Syringes East Coast USA Conference, industry leaders will meet in Boston to share their insights on best design practice, drug compatibility within the whole supplier chain and challenges with manufacturing and drug delivery.

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

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