Our Expert Network

31. Were We (Are We) Correct About Oligonucleotides? 11/12/2024

    In 2023, Chief Editor Louis Garguilo proclaimed it was "the year of oligonucleotides," and 2024 would be an incredible growth year for oligos. How are those proclamations panning out? He takes a detailed look, including the important role in the expected growth played by CDMOs.

32. Emerging Partnership Trends In Oligo-Based Medicines 11/6/2024

    The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.

33. Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards 10/28/2024

    A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

34. Tune Therapeutics On Clinical Readiness, Technology Adoption 10/18/2024

    Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

35. How Platform Technologies Are Shaping The Gene Therapy Landscape 10/18/2024

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

36. 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. 

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    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides.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

38. 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.

39. 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.

40. 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.