RNA Outsourcing Resources

31. Phase IIb Trial: Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer 12/5/2024

    This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.

32. Exploring The Spatial Distribution Of mRNA-Lipid Nanoparticles Using MALDI MSI 4/23/2025

    Learn how leveraging high-resolution MALDI-MSI can advance the development of lipid nanoparticle-based therapies, uncovering spatial biodistribution, pharmacokinetics, and organ-specific variability.

33. Selection And Evaluation Of Hybridization Capture Probes For LC/MS Analysis Of Oligonucleotides 4/23/2025

    To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.

34. Advancing Cell And Gene Therapy Clinical Development In 2023 7/19/2023

    Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.

35. Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies To Clinic 11/20/2024

    In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.

36. Addressing And Adapting To Evolving mRNA Market Trends 7/6/2022

    Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.

37. Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation 4/30/2024

    In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.

38. Step-By-Step Guide To Tech Transfer Preparation And Execution 10/31/2024

    How does a sponsor accurately transfer detailed knowledge about its product composition, development, and current manufacturing processes to its CDMO?

39. Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics

    What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?

40. Expertise In RNA Therapies: Client Success Stories 2/17/2023

    Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.