INSIGHTS ON CELL & GENE MANUFACTURING AND LOGISTICS

• At The Forefront Of Pharma 4.0

  There is no full Pharma 4.0 manufacturing in place yet, but there are first innovations to build on.

• Aiming To Solve The 3 Key Challenges Of CAR T-Cell Manufacturing

  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.

• Solving Logistic Complexities In The Era Of Personalized Medicine

  Examine how the next generation of therapies is disrupting supply chain logistics and explores solutions for the complexities within cell and gene therapies.

• Solving Logistic Complexities In The Cell And Gene Supply Chain

  Due to their fragile nature and complex development pathways, cell and gene therapies place extreme demands on clinical and commercial supply chains. Explore the heightened attention to chain of custody, environmental conditions, packaging, regulatory, technology and customs requirements for successful supply chain strategies.

• Single-Source Supply Chain Solutions For Today’s Clinical Trial Ecosystem

  Marken provides a best-in-class Quality Management System, a global GMP Depot Network, Direct-to/From-Patient, Home Healthcare nursing services and industry-leading expertise all under one single-source provider.

• Achieving Cell And Gene Manufacturing Scalability: A Conversation With AVROBIO’s Geoff MacKay

  Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

• Secure The Cell Therapy Supply Chain From Bench To Bedside

  While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks. 

• 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.