Guest Columns & From The Editor

  1. Inside PDA’s Technical Report No. 81

    Parenteral Drug Association (PDA) recently released Technical Report No. 81, “Cell-Based Therapy Control Strategy,” written by PDA’s Cell and Gene Therapy Task Force. Michael Blackton, Global Head of Quality at adaptimmune and PDA’s Co-Chair of the Cell and Gene Therapy Interest Group co-authored the report. Blackton’s also a member of the Biopharmaceutical Advisory Board and International Board of Directors. Here, he breaks down Technical Report No. 81 and explains the report’s biggest takeaways.

  2. Spark’s Bartock On Streamlining The Supply Chain

    I caught up with Ryan Bartock, Head of Supply Chain and Network Strategy at Spark Therapeutics, to talk through some of the gene therapy sector’s heftiest supply chain challenges. In Part 1 of a 2 part series, hear what advice he has for pharma, bio executives, and CMOs to successfully manage and even streamline the supply chain.

  3. Overcoming The Unique Filling Challenges Of Autologous Therapies

    Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

  4. CAR T-Cell Therapies In The EU5: What Can We Expect From Payers?

    The difficulty of balancing paying for innovation with budgets has plagued Europe for years, and the emergence of cell and gene therapies has only exacerbated that conundrum. The launch of the first two CAR T-cell therapies will likely prove to be useful case studies for how payers and physicians will respond to this new reality.

  5. Sneak Peek: The Unique Challenges Of Cell And Gene Supply Chains

    Two of the field’s most valuable luminaries representing both academia and industry — Dr. Bruce Levine and Simon Ellison, ISCT Commercialization Committee — discuss determining how CMOs can and should successfully manage cell and gene therapy supply chains.

  6. Philadelphia: The Cell And Gene Therapy Sector’s New Normal

    Being a Greater Philadelphia Area resident affords me the opportunity to meet and collaborate with scientists, doctors, researchers, and other highly skilled professionals knee-deep in the cell and gene therapy sector. From the University of Pennsylvania to CHOP to Spark Therapeutics to Tmunity and many, many more, Philadelphia not only continues to shine as the geographical standout for innovation and continuous forward movement for cell and gene therapies but also as the smart economical choice for SMEs in the field.

  7. Who Will Win The Regenerative Medicine For Diabetes Race?

    Regenerative medicine could be a game-changing approach to meet the needs of insulin-dependent patients. Although the field is still in its infancy, the initial clinical data looks promising. This article takes a closer look at a few innovative companies that are racing to bring the first regenerative medicine for diabetes to the market.

  8. Critical Considerations For Packaging And Delivery Of Gene Therapy Products

    The temperature-sensitivity of cell and gene therapies, their personalized nature, and their circular (“vein-to-vein”) supply chain make maintaining a seamless supply chain critical; however, it is not easily achieved.

  9. Adaptimmune’s VP QA CMC Talks Quality Management

    One conversation with Michael Blackton, VP QA CMC at Adaptimmune, proves why he is known for being a passionate, results-oriented leader focused on QA, analytical development, and more. Validate for yourself as Blackton answers my questions about process development and quality management. And, he provides a fresh outlook on recruiting senior-level executives.  

  10. Nontraditional Design Concepts To Accelerate CAR T Processing

    The first round of CAR T therapies, now considered “legacy,” is largely being produced using biosafety cabinets and bench-top incubators with multiple open operational steps. The next generation of production processes will reduce or eliminate the open operations and automate cell-based manipulations.