OP White Papers - random

  1. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

  2. 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.

  3. Pharmaceutical Spray Drying – Technology And Applications 1/21/2025

    Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.

  4. 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.

  5. Improving Safety And Efficacy With Charged Variant Characterization 5/14/2024

    Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

  6. AI Implementation To Enhance Quality 2/11/2025

    Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

  7. The Relevance Of Polymorph Screening In The Pharmaceutical Industry 3/31/2025

    Polymorph screening identifies different solid forms of active pharmaceutical ingredients, optimizing drug stability, solubility, and manufacturability. This process ensures quality, regulatory compliance, and intellectual property protection in pharmaceutical development.

  8. Streamlining ADC Development: Advantage Of An All-In-One Solution 6/2/2025

    Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

  9. Overcoming Challenges To High-Concentration Formulation Development 3/25/2025

    Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.

  10. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

    Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.