Outsourced Pharma App Notes & Case Studies

  1. Aseptic Expertise And Delivery Of Services 8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

  2. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

  3. Benchmarking Filtration Performance Of TFF Cassettes 5/30/2025

    Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

  4. Developing A Project Management Office (PMO) At A Small Manufacturing Site 8/11/2025

    Discover how implementing a Project Management Office transformed a small manufacturing site into a high-performing, strategic asset within a global network.

  5. Facility-Fit-Driven Process Development For A Monoclonal Antibody 11/19/2025

    See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

  6. Seamless Onshoring From China-Based CDMO 11/19/2025

    Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

  7. Mitigating Powder Flow And Static Issues Using SYLOID® Mesoporous Silica 10/7/2025

    See how incorporating small amounts of mesoporous silica during micronization can significantly enhance powder flow, thereby making subsequent blending and formulation more efficient and consistent.

  8. Lyophilization To Enable Drug Products Containing Labile Molecules 6/6/2025

    Develop lyophilized formulations to overcome stability challenges and significantly extend the shelf life of sensitive therapeutic products.

  9. CDMO Accelerates Contract Manufacturing With Electronic Batch Records 9/18/2024

    A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

  10. Optimizing Bispecific Antibody Expression Via Multi-Omics Analysis And Vector Redesign 12/17/2025

    Discover how diagnosing ribosome pausing sites and optimizing codon usage dramatically improves bispecific antibody titers, turning difficult-to-express candidates into viable therapeutics.