OP White Papers - random

  1. Operational Success By Strategic Investment 1/22/2026

    Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

  2. Selecting A CDMO For Custom Activated PEGs 1/27/2026

    Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.

  3. Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies 5/5/2025

    Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.

  4. 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.

  5. Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up 1/22/2026

    In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

  6. 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.

  7. Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies 12/29/2025

    Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.

  8. Revolutionizing Drug Discovery From "Undruggables" To AI 6/10/2024

    Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.

  9. Engineering Reliability In Cell Therapy Manufacturing 2/3/2026

    A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.

  10. 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.