OP White Papers - random

  1. Support Of Scale-Up And Technical Transfer Through Understanding Equipment 10/16/2024

    See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

  2. Insights And Effective Strategies For A Successful Technology Transfer 11/1/2024

    Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.

  3. Bioconjugates – An Increasing Diversity, A Blossoming Of Therapeutic Applications 10/24/2024

    Harness the power of bioconjugation to revolutionize targeted therapies, enhance drug efficacy, and reduce side effects, paving the way for more precise and effective treatments across a range of diseases.

  4. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

    Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

  5. Why An Integrated Approach Ensures Smooth Entry Into The European Market 3/25/2025

    Simplify your EU launch and boost returns. Learn how to manage regulatory hurdles, access a huge patient population, and gain end-to-end commercial support.

  6. Achieve Higher Targeted Concentrations 9/30/2025

    Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

  7. Small Molecule API Production: Unveiling The Impact Of Fermentation 5/16/2024

    Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practice.

  8. Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities 6/12/2025

    Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

  9. AAV-Based Gene Editing For Huntington's Disease 10/28/2025

    LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

  10. Developing Effective Procedures 10/21/2024

    Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.