Featured Articles

41. 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.

42. Functional Performance Of Stoppers To Support Multipuncture Use

    Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.

43. A Step Change In Pharmaceutical Glass Packaging Innovation

    Valor Glass represents a significant, and much needed, step forward for glass innovation. Review the findings and learn how an aluminosilicate formulation can lower your glass vials' extractables profile.

44. Addressing Glass Particulates In Injectable Drug Formulations

    Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

45. 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.

46. 4031 Ready Methods Reduce E&L Timelines

    An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

47. 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.

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    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

49. A Proactive Approach To Reducing Particulate Risk

    A biotech that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines.

50. Your Approach To USP <382> For Your Drug Product Packaging

    The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.