spacer
home > white papers > The Impact of Components on Drug Quality and Risk Mitigation - West Pharmaceutical Services, Inc.
WHITE PAPERS
logo_West_Pharm6.jpg

West Pharmaceutical Services, Inc.

phone America +1 610 594 2900
web http://www.westpharma.com
email 530 Herman O. West Drive Exton, PA 19341

The Impact of Components on Drug Quality and Risk Mitigation

Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

PPMA Group Industry Awards 2018 Call for Entries – Deadline 31st July

The PPMA Group Industry Awards, which recognise manufacturing excellence, technical innovation, entrepreneurship as well as outstanding achievement and contribution to the industry, will this year take place at a new venue – the Hilton Birmingham Metropole Hotel at the NEC - on the 25th September 2018.
More info >>


White Papers

Delivering Fit For Purpose Biomanufacturing CHO Cell Lines

Fujifilm Diosynth Biotechnologies

The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
More info >>


Industry Events

SCOPE Europe: Summit for Clinical Ops Executives

16-17 October 2018, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clin ops execs, functional heads, category managers and those responsible for the planning and management of clinical trials in Europe and the Rest of the World.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement