OP White Papers - random

  1. Optimizing Safety Measures For rAAV Therapies 10/11/2024

    Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

  2. Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes 4/8/2025

    The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

  3. Flow Chemistry Vs. Batch Processes 6/10/2025

    Explore how continuous flow chemistry can accelerate your chemical development with greater efficiency, safety, and sustainability compared to traditional batch processes.

  4. The Role Of The Technical Transfer Executive Sponsor 10/30/2023

    Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

  5. Mastering Technology Transfers: Our Blueprint For Success 4/16/2025

    Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

  6. SMB Technology: Optimizing API Purification 6/13/2025

    Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

  7. Analytical Techniques For Assessing Quality Of Therapeutic Proteins 6/5/2025

    Evaluating quality attributes of therapeutic proteins requires a strategic, regulation-compliant selection of analytical techniques that consider molecular characteristics and phase to ensure characterization.

  8. 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.

  9. 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.
  10. Is Sustainability The Key To Agile Biopharma Manufacturing? 3/18/2025

    In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.