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. 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.

6. 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.

7. 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   The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides.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.

8. 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.

9. Strategies To Address FDA CMC Trends For mRNA Therapies 9/24/2024

   A CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications.

10. Araris Doubles Down With Dual-payload ADC 9/24/2024

    Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.