OP White Papers - random

  1. 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.

  2. History Of Peptides In Medicine: From Early Chemistry To The GLP-1 Era 4/21/2026

    Peptide therapeutics from early chemical breakthroughs to today’s metabolic drugs, highlighting scientific, clinical, and manufacturing advances shaping modern drug development.

  3. Why Tailored CDMO Support Is A Non-Negotiable In Sterile Fill-Finish 4/13/2026

    Modern injectable programs require adaptable manufacturing strategies. Learn how flexibility, technical depth, and collaboration reduce complexity, manage change, and protect long‑term supply.

  4. Spray Dried Biologics For Injectable Dosage Forms 5/15/2026

    Spray drying enables scalable production of stable, high‑concentration biologics as sterile powders, improving delivery, reducing costs, and overcoming limitations of traditional freeze‑drying methods.

  5. SEDDS: Improving Oral Bioavailability Of Poorly Soluble Compounds 8/20/2026

    Nearly 90% of marketed drugs have poor water solubility. Learn how self-emulsifying drug delivery systems (SEDDS) resolve oral bioavailability failures across BCS Class II and IV compounds.

  6. 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.

  7. Spray Dry Biologics For Oral Dosage Forms 5/15/2026

    Spray drying enables stable oral delivery of biologics by creating protective dry powders, improving bioavailability, stability, and targeted release compared with traditional formulation methods.

  8. Science With Purpose: Advancing Sustainability In Biopharma Testing 6/9/2026

    Learn how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.

  9. Quality By Design: Understanding And Securing Virus Clearance 4/22/2026

    Data-driven virus clearance improves risk assessment, process insight, and study design. Learn how Quality by Design cuts late-stage risk while strengthening regulatory confidence and viral safety.

  10. FIH: Reach Milestones Sooner With A Technology-Driven Approach 2/12/2026

    Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.