INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• Bulletproof Your Supply Chain: Hope For The Best, Prepare For The Worst

  Explore how to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how to use a risk-based approach to determine where a contingency plan is needed.

• Solutions For Cold-Chain Handling: PTFE Containment Is A Viable Option For Temperature Sensitive Drug Substance Protection

  Drug manufacturers seeking a more robust solution for single-use cold-chain containers are looking to options made with polytetrafluoroethylene (PTFE) fluoropolymers, which may be less susceptible to failure and breakage at cold temperatures.

• Cold Chain Handling In Gene Therapy: Polymer Technology Takes Freeze Containers Beyond The Breaking Point

  There is no way around the extreme conditions bulk drug substances are subjected to when getting from point A to point B. Although logistics solutions like RFID tags and temperature sensors have become common to track and monitor products in-transit, the single-use storage containers that so many manufacturers rely on are often not up to the challenge of keeping product secure. In this article learn about new materials being considered for single-use cold chain storage containers, to reduce or eliminate issues with durability at cold temperatures.

• GORE® STA-PURE® Flexible Freeze Container 50-Ml Stability Container Assembly

  See how the 50-milliliter (ml) stability container assembly supports handling, transport and storage of biopharmaceutical intermediates, after freezing at -86°C (-123°F).

• Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances

  In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

• How Customer Forecasts Support The Integrity Of The Biopharma Supply Chain

  Receiving customer forecasts as early and as completely as possible is critical to the success of the supply chain continuum.

• Celsius® FFT: Safeguarding Your Drug Substances In Conventional Freeze & Thaw Manufacturing

  Implementing a reliable cold chain operation requires a robust container system for storage and transport of bulk drug substance. Celsius® FFT (Flexible Freeze and Thaw) is a unique bag-in-shell system that replaces traditional freezing and thawing methods. 

• Celsius® CFT: Safeguarding Your Drug Substances In Controlled-Rate Freeze & Thaw Manufacturing

  Celsius® CFT (Controlled Freeze and Thaw) is a complete system for proven freeze-thaw performance, providing a fully integrated, end-to-end solution designed to minimize manual handling of drug substances.

• Managing Frozen Transport Logistics In The Biopharmaceutical Cold Chain

  As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become more complex.  This paper provides a framework for making challenging decisions linked to cold chain management before outlining potential solutions that could solve many of the issues surrounding the frozen transfer of biopharmaceuticals.

• Improving The Supply Of Single-Use Technologies

  The use of single-use technologies has been growing steadily over the past decade, but there are challenges. Explore the potential solutions for single-use supply constraints.