Our Expert Network

31. FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics 12/11/2024

    FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

32. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

    Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

33. RNase Control: An Overview With Market Trends 12/2/2024

    This article shares an overview of ribonuclease (RNase) control and some associated macro market research.

34. Developing Bespoke Antisense Oligonucleotides To Treat Rare Diseases 11/26/2024

    EveryONE Medicines CEO, Kent Rogers, explains the company’s mission to address a major unmet need in children with rare neurodegenerative diseases, one patient at a time.

35. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why 11/19/2024

    The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

36. CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides 11/18/2024

    Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

37. RNA Therapeutics: New Market Research 11/14/2024

    According to our new market research, the RNA therapeutics industry is predicted to exceed $31 billion by 2032. This article shares key findings and trends.

38. 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.

39. 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.

40. 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.