Expert Insights On Cold Chain

41. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay 10/4/2023

    On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.

42. What We Can Learn From The Cancer Drug Shortages 8/30/2023

    The dramatic shortage of essential cancer drugs, including cisplatin and carboplatin, has exposed gaps in the pharmaceutical supply chain. Here's what we can learn from it about building resilience and how alternatives like monoclonal antibodies can help reduce reliance on cornerstone therapies.

43. FDA Issues Second DSCSA Warning Letter — What Does This Mean? 8/16/2023

    In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.

44. How Serum Institute Delivered A 'Breath Of Relief' In 6 Months 8/16/2023

    Kedar Gokhale, an executive director at Serum Institute of India, explains how the world's largest vaccine manufacturer refocused a construction project and achieved commercial scale for the Covovax vaccine in just six months. The feat earned Serum two 2023 ISPE Facility of the Year Awards. This Q&A is part of a feature series on select FOYA winners.

45. A Practical Proposal For Standardizing Traceability Of Cell And Gene Therapies 7/21/2023

    For personalized therapies, it is imperative that patients are treated with the product meant specifically for them. Mistakes in products or on labels that lead to the wrong therapy being administered to the patient are likely to have fatal consequences. BioPhorum presents a practical vision for standardizing the traceability of cell and gene therapies across the value chain.

46. Practical — And Crucial — Actions To Take Now For DSCSA Compliance 6/29/2023

    Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now.

47. 4 Key Considerations For Onshoring Or Nearshoring Of Drug Production 6/28/2023

    Is reshoring or nearshoring right for your organization? It's important to undertake rigorous internal assessments to arrive at a decision. Here are four key considerations.

48. 3 Action Items For The US Bio/Pharma Industry To Mitigate Supply Vulnerabilities 6/12/2023

    The United States’ reliance on foreign manufacturers of API has been a known fact for several years. We can mitigate our supply vulnerabilities, but bio/pharma companies and the FDA both have roles to fill in this need.

49. Will POC Manufacturing Unlock The Value Of Autologous Cell Therapies? 6/5/2023

    To shorten the treatment journey for autologous cell therapy patients, a promising model that appears to be emerging is point-of-care (PoC) manufacturing in major cancer and academic medical centers and hospital networks. PoC  has the potential to address other ongoing concerns, such as the reduction of risks and costs.

50. 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.