BIO From The Editor and Guest Columns

  1. Comparing In-house Vs. Outsourced Manufacturing Strategies For CGTs 10/7/2024

    Each approach has its advantages and drawbacks. This guide should help you decide which one, or perhaps a hybrid strategy, is best for your company.

  2. Expert Voices: Why Aren't QC Labs Fully Automated Yet? 10/4/2024

    Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

  3. A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies 10/2/2024

    This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

  4. What To Do When Your Regulatory Findings Need Quality Risk Management Action 10/2/2024

    More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

  5. How Platform Technologies Are Shaping The Gene Therapy Landscape 9/30/2024

    Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.

  6. Advanced, Cost-Saving Techniques Improving Cell Therapy Production 9/30/2024

    Low throughput and intense resource demand limit patient access to cell therapies. Automation and in vivo manufacturing are poised to lower those barriers.

  7. Gene Therapy CMC Experts On Late-Stage Process Changes 9/27/2024

    At the 2024 Bioprocessing Summit, a panel of CMC experts spoke about the challenges commercializing gene therapies, specifically focusing on considerations for late-stage process changes.

  8. Team Topologies For Outsourced CMC Development 9/27/2024

    When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.

  9. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

  10. This Digital Twin Approach Aims To Optimize ATMP Production 9/25/2024

    Manufacturing therapeutic cells includes labor-intensive processes. These researchers are developing a way to increase yields through cost-effective expansion protocols.