Featured Articles

81. A Glass Package Designed Specifically for Pharmaceutical Use

    A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.

82. Extractables And Leachables – Assessing Risk In A Complex Landscape

    It is not surprising that there is still confusion on the extractable and leachable topic. Guidances, where available, do not give step by step instructions on testing.

83. Mitigating Particulate Risk In Injectables

    What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?

84. Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

    Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

85. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

86. Is It Ever Too Soon To Start Your Performance Testing Assessment?

    Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

87. Orphan Drugs – Small Batches That Demand Attention

    Orphan drugs, or the drugs made in small batches for immediate medical attention, have the ability to be both life changing and lifesaving for patients suffering from a rare disease.

88. Can Drug Device Manufacturers Achieve Operational Excellence Through A Digital Facility?

    Information gathered in a manufacturing environment equips a facility with the tools to react to issues in real time and respond more quickly to customer requests.

89. Reduce Costs And Improve Adherence For Self-Administration Of Biologics

    There is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy. 

90. Parenteral Packaging And Delivery Systems: Container Closure Integrity

    Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.