RNA Outsourcing Resources

51. The Sponsor's Clinical Development Handbook For Gene Therapy Trials 6/21/2024

    Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

52. From LAL To rFC: The Evolution Of Endotoxin Testing 6/26/2026

    Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.

53. Getting CMC Right For Emerging Technologies 12/20/2023

    Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

54. How To Build Effective Clinical Trial Oversight And Leadership 7/14/2025

    In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

55. 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.

56. Improving Toxicology Testing For Inhalation Products 1/22/2024

    By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.

57. Accelerated Development: Gene Therapy Vs. Small Molecule 12/26/2023

    Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

58. Why Risk Analysis And Lane Qualification Matter 5/28/2026

    Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.

59. Complexing RNPs: Have You Established Your Clinical Acceptance Criteria? 5/13/2025

    Ensuring consistency and quality at every manufacturing stage is critical for CRISPR-Cas gene editing. To achieve this, the FDA recommends establishing well-defined acceptance criteria for RNP formation.

60. Contract Design And Development Vs. In-House: Finding The Best Fit 11/18/2024

    Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.