OP White Papers - random

  1. EMA Support For Rare Disease Therapies 6/10/2025

    Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.

  2. Considerations For Developing The Recirculation/Perfusion Process 6/6/2024

    Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.

  3. Overload Setting – Tricks And Techniques 9/23/2024

    Learn how a partner company that is committed to assisting manufacturers with calibration and optimal set-point establishment can serve as a valuable resource in achieving optimal tablet production.

  4. 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.

  5. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

    Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

  6. Preclinical Immuno-Oncology Models For CAR T-Cell Therapy Development 5/21/2025

    The following preclinical IND-enabling oncology studies conducted by scientists at Aragen over the past 10 years highlight the role of robust preclinical models in advancing the fight against cancer.

  7. Cell Line Development For Bispecific Antibodies 8/18/2025

    See how the recently described cell line development paradigm shift, enabled by the Leap-In transposon platform, can extend to the development of bispecific monoclonal antibody-producing cell substrates.

  8. Leak Rate Testing for Freeze Dryers: A Scientific Approach 10/16/2024

    Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.

  9. Enhancing Safety And Efficacy Of mRNA-Based Therapeutics 2/11/2025

    Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.

  10. 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.