Our Expert Network

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   The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides.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

2. 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.

3. 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.

4. Where Are They Now? Carisma Therapeutics 9/24/2024

   In three years, Carisma Therapeutics has gone public, entered a broad collaboration with Moderna, and ceased development of its original CAR-Macrophage candidate, in favor of CAR-Monocyte therapies. Carisma expects to release CT-0525 Phase 1 data by the end of 2024.

5. Wish SUS Cost Less? Survey Says Your Peers Do, Too 9/6/2024

   BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.

6. Great siRNA Science Or Savvy Business Acumen? You Need Both 8/28/2024

   Silence Therapeutics has two wholly owned siRNA therapies now in clinical trials and one partnered program with AstraZeneca. Silence's CEO discusses the need for good science, making smart business decisions, and cultivating partnerships.

7. Developing & Manufacturing Oligonucleotides: An Overview 8/22/2024

   An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.

8. A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services 8/15/2024

   These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

9. Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise 8/12/2024

   BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.

10. Scaling RNA Production From The Lab To The Clinic 8/9/2024

    Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.