Press release
Pre-Filled Syringes - Chemical Compatibility and Design Strategies
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
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
Event organiser
1 Westminster Bridge Road, London, UK
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
Event organiser
1 Westminster Bridge Road, London, UK
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