Injectable Drug Delivery Articles

  1. Navigating The Pros And Cons In Annex 1's PUPSIT Requirements 7/12/2023

    Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.

  2. Combination Product QMS Requirements For The EU Market 6/30/2023

    Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

  3. Container Closure Integrity Testing Strategies For Gene Therapies 6/7/2023

    Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield. This article provides perspectives on CCIT strategies to minimize the impact on gene therapy drug product batch yield by examining recent industry survey results as well as best practices.

  4. Let's Explore Packaging For Aseptic Manufacturing 5/19/2023

    When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.

  5. 5 Hot-Button Issues In Parenteral Packaging 5/16/2023

    Five key issues related to parenteral drug packaging came to the forefront of the PDA Parenteral Packaging Conference held in Venice, Italy, in April.

  6. The Global Market For Generic Sterile Injectables To Double In Value By 2032 5/15/2023

    According to new analysis at insightSLICE, the global generic sterile injectable market size was estimated to be $79.95 billion in 2022 and is expected to grow to reach $159 billion by 2032. What are the key factors and trends driving this growth? This author shares the key data-led insights.

  7. All You Need To Know About Contamination Control Strategies, Part 1 5/12/2023

    In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.

  8. Addressing 3 Challenges Of Developing Or Using A New Excipient 5/8/2023

    As the world discovers new molecular entities, new solutions for and innovation of excipients are more critical than ever. However, they are often overlooked. Let’s look at how to address three key challenges: risk aversion, an inconsistent feedback loop between pharma companies and excipient suppliers, and the current lack of regulatory body-backed innovation programs.

  9. Topical Biologics In Ophthalmology? 3/21/2023

    A recent clinical study of an eyedrop formulated with Grifols’ Immunoglobulin-based Flebogamma DIF offers cause for optimism among multiple stakeholders. It could become the first-approved topically administered biologic therapy for dry eye disease. 

  10. Examining Protein Domains For Targeted Biologic Drug Delivery 2/10/2023

    The use of individual protein domains that have been well characterized to create hybrid proteins with desired combinations of biochemical properties is a promising new approach to biologic pharmaceutical agents. I share recent work with regard to the parathyroid hormone, which has important roles in regulation of calcium and bone.