INSIGHTS ON CELL & GENE MANUFACTURING AND LOGISTICS

• New Container Protects Bulk Frozen Biopharmaceuticals

  The growing trend of biologic drugs, which by nature require cold-chain handling to maintain stability and efficacy and the market trend to centralized production of active ingredients, which often means shipping them in bulk to a separate location for manufacturing the final drug has led to the need for a performance pouch that addresses these challenges. Learn more about a flexible freeze container that maintains package integrity after freezing at −86 °C. (−123 °F) and minimizes product loss due to package failure due to its durable design.

• What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?

  When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

• Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins

  Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.

• Trends In Cold Chain Storage For Biologics

  Packaging is critical, as biotechnology products become more valuable and require colder storage.

• Vendor Partnering In A Bioprocess Manufacturing And Supply Chain Ecosystem

  As novel therapies produced and stored under extreme conditions become more common, containers that were adopted decades ago are increasingly unable to meet project needs and regulatory standards. New single-layer assemblies, made with more robust materials and without the curing agents, antioxidants, plasticizers, or adhesives that represent potential contamination sources, may offer companies a safer, more efficient choice.

• How To Build A Robust Packaging Strategy For Rapid Commercialization

  Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

• 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.

• 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).

• 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.

• Single-Use End-To-End Solutions – Flexible, Scalable And Reliable

  In an extremely complex, competitive and constantly evolving sector such as the biopharmaceutical industry, flexibility is key, not least since it is an immensely varied and compliance-driven field. This is one of the reasons why more and more logistics solutions – covering all steps from filling to freezing, thawing and distribution – are primarily based on single-use technologies. Read more on you can optimize performance and efficiency with single-use technologies.