RNA Outsourcing Resources

31. Avoiding The Pitfalls Of LNPs And Complex Formulations

    Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

32. 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.

33. Lessons In Scaling Lipids Production And Purification 12/13/2021

    The speed at which the pharmaceutical industry is now developing and manufacturing mRNA drug products at large scale is astounding, yet it has highlighted supply chain vulnerabilities to make the required pharmaceutical ingredients such as lipids.

34. Delivering The Promise Of Gene Therapy 1/22/2024

    Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.

35. 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.

36. Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics

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

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. 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.

39. Cell And Virus Banking In OV Development And Manufacturing 5/14/2024

    Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.

40. Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions 4/21/2021

    Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.