Expert Insights On Cold Chain

81. FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance 5/24/2022

    The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market launch based on anticipated approval of a pending NDA, ANDA, BLA, or combination product assigned to CDER.

82. FDA Proposes Updated Guidance On Verification Systems Under DSCSA 4/19/2022

    The FDA is soliciting comments on its proposed update to its "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs" guidance. When a trading partner suspects counterfeit or fraudulent products, or receives a request for verification from the FDA, partners are required to quarantine the product and to investigate its legitimacy. 

83. mRNA Vaccines: Key Considerations For Development & Manufacturing 4/4/2022

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

84. Data Management: 5 Best Practices For Emerging Biotechs 2/14/2022

    Whether your ambitious upcoming pharma startup or biotech has its sights set on being the world’s first in your field, or a lucrative exit through a strategic company sale, starting out with good data management practices will set you up for success for the future you envision.

85. Failed Process Performance Qualification: Lessons Learned 1/24/2022

    Recently, Immunovant was working on a low demand fc fusion protein that was produced in a small number of lots with a very small clinical history. The process performance qualification (PPQ) didn’t go as planned; quality attributes dropped to unacceptable levels and the cell health declined. This is the story of how the team identified the problem and then fixed it.

86. Aiming To Solve The 3 Key Challenges Of CAR T-Cell Manufacturing 1/18/2022

    These authors share their best practices for solving the three key challenges of CAR T-cell manufacturing (supply constraints, scalability issues, and storage and logistics challenges) using their experiences with Epstein Barr Virus (EBV) T cells.

87. AI & Intelligent Technologies: Finding The Right Fit For Your Pharma Or Medtech Company 1/14/2022

    This article takes a closer look at AI and intelligent technologies in biotech, medical devices, and pharma, and what we can expect to tackle in 2022 and beyond. The article also identifies some of the new concerns and challenges with disruptive technologies and risk management, and discusses a technology and generation timeline.

88. Merck's 2 Lessons Learned: Overcoming Single-Use Supply Challenges 1/12/2022

    The COVID-19 pandemic has caused severe disruption to supply chains, making it difficult to get material. At Merck, a situation occurred recently wherein they were unable to get the filter assembly they needed, and their supplier was struggling to meet demand. This article shares Merck's two lessons learned from the experience.

89. EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance 12/28/2021

    With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.

90. The Data Integrity Body of Knowledge Expands with New & Pending Guidances 12/20/2021

    Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.