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Pre-Filled Syringes - Chemical Compatibility and Design Strategies

ID: 1547166
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(businesspress24) - 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

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

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

More information:

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smi-group, pre, filled-syringes,

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published by: RealWire
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Date: 02/27/2019 - 17:18
Language: English
News-ID 1547166
Character count: 2794
Firma: RealWire
Ansprechpartner: Leah Wood Feedback to about Pressrelease-id:
Stadt: Lincoln
Telefon: 1522883640

Meldungsart: bitte
Versandart: Veröffentlichung
Freigabedatum: 27/02/2019

Number of hits: 474


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