Expert Insights On Cold Chain

61. 6 Strategies To Protect Your Biologics Supply Chain In 2023 1/25/2023

    Instead of automating everything — which costs a lot and doesn't solve every problem — drug makers should focus on building scalable, need-specific supply chain operations. This article discusses supply chain resilience strategies biotech companies can reasonably control.

62. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

63. New Approaches For Drug Substance Freezing And Storage 1/12/2023

    The latest in drug substance-refrigeration technology gives the biopharmaceutical industry options for freezing and storing liquid DS. Here are some insights for optimizing setups based on application, facility, and budget.

64. 1 Year Out, Where Do We Stand On DSCSA Implementation? 11/21/2022

    This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.

65. Digital Twins & The CGT Value Chain: A Universe Of Possibilities 10/21/2022

    The cell and gene therapy revolution is coinciding with advanced digital technologies. At the forefront are digital twins, which combine at-scale computing, modeling methods, and IoT connectivity to create full-scale digital replicas of physical assets or real-world processes, such as factories, value chains, and even humans.

66. Autonomous Supply Chain Planning Is Within Reach 10/19/2022

    In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.

67. Attributable Data Integrity in Modern Biopharma Using ALCOA Principles 8/29/2022

    This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.

68. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

69. 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.

70. 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.