Insights On CONTRACT PHARMA MANUFACTURING

  1. How To Double Up With A CDMO To Reduce Risk 12/12/2025

    Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.

  2. Biologics CDMO: 3 Qualities Often Overlooked 12/12/2025

    A partnership can deliver more than process support. Transparency, regulatory expertise, and IP protection are critical benefits that safeguard your autonomy and innovation while enabling global success.

  3. Gaining A Competitive Edge Through Regulatory Compliance Confidence 12/10/2025

    Achieving regulatory compliance confidence is paramount for safety and competitive advantage. Adherence to standards and robust risk mitigation are essential to avoid delays and detrimental outcomes.

  4. Science To Success: CMC Strategies That Drive Market Readiness 12/10/2025

    Learn how a scientifically grounded framework for early-phase CMC development, integrating QbD and proactive risk management, helps de-risk drug development and accelerate the journey from molecule to market.

  5. Challenges And Solutions In Lyophilization Development For ADCs 12/10/2025

    Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

  6. Benefits Of Isolator Technology In Fill-Finish 12/10/2025

    Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.

  7. Building A Biomanufacturing Ecosystem For Supply Agility Starts Early 12/9/2025

    A unified, modular biomanufacturing ecosystem combining rapid CLD, flexible purification, and scalable global capacity can accelerate production and strengthen supply agility amid rising demand.

  8. Eliminate Risk From Your Viral Vector Tech Transfers 12/5/2025

    Explore strategies to simplify viral vector tech transfers, reduce risk, and maintain quality under tight timelines, as well as a case study that demonstrates how to streamline this critical process.

  9. Navigating Regulatory Expectations For Injectable Packaging 12/4/2025

    Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.

  10. OSD Early Stage: Getting Oral Products Into Clinic Early 12/2/2025

    Strategic formulation choices and early solubility screening are vital for overcoming poor solubility and limited supply to accelerate the path to first-in-human trials and stand up to the pressure.