Featured Articles

31. West Expands NovaGuard™ Platform of Products for Safe and Effective Injectable Drug Delivery 7/2/2013

    West Pharmaceutical Services, Inc., a leading global developer and manufacturer of components and systems for injectable drug delivery, today announced the expansion of the NovaGuard portfolio of needle safety products.

32. West And Janssen Biotech Agreement To Develop A New Self-injection Technology 9/5/2012

    West Pharmaceutical Services announced an agreement with Janssen Biotech, Inc. to collaborate on the development and manufacturing of an innovative self-injection product. 

33. Holistic QbD: A Key To Improved Profitability And Sustained Competitive Advantage With Sterile Pharmaceutical Products 8/9/2012

    Pharmaceutical companies are faced with assuring that new quality and compliance paradigms can be met while facilitating profitability to continue adequate business reinvestment. By Fran DeGrazio, Vice President, Global Research and Development, Pharmaceutical Packaging Systems West Pharmaceutical Services, Inc.

34. Sterilization Of Ready-To-Use Components 12/2/2011

    Inadequate aseptic processing operations, human error, high endotoxin levels, microbial contamination and insufficient sterility testing have all generated FDA warning letters.

35. The Importance Of A Human Centered Approach To Product Development

    To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.

36. The Importance Of Strategic Alliance Partners

    Complex drug delivery systems require teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms for patient use. These alliance partners must ensure self-administered therapies are safe, easy to use, and effective. 

37. De-Risking Visible Particles Through Component Selection

    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

38. Gene Therapy: Maintaining Sterility At Low Temperature Storage

    A gene therapy for pediatric Spinal Muscular Atrophy required a leak and break-resistant container which maintains sterility over product shelf life, through freeze and defrost cycles.

39. Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers

    Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.

40. FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III

    The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.