OP White Papers - random

  1. Setting The Standard For Plasmid DNA Production 10/16/2024

    Discover how Boehringer Ingelheim’s expertise in plasmid DNA manufacturing can propel your innovative therapies forward and transform patient care.

  2. CHO Cell Lines For Recombinant Protein Production 6/2/2025

    Discover how new strategies in CHO cell line development are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.

  3. Analytical Techniques For Characterization, Release, And Stability Testing 4/28/2025

    Review the analytical considerations for subunit vaccines, vaccines that contain only the antigenic component(s) of a pathogen, and more specifically the assays needed.

  4. White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges 10/16/2024

    Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.

  5. 5 Steps To Design A Microbiological Performance Qualification For Facilities 4/21/2025
    Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
  6. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

  7. Extractables And Leachables Testing 4/9/2024

    Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.

  8. Phase-Appropriate Approaches To Manufacturing And Testing 3/14/2025

    Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

  9. Mitigating Nitrosamine Risks In Pharmaceuticals 6/25/2024

    Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.

  10. Antibody-Drug Conjugates – Catalysts For Chemistry 5/16/2024

    Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.