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. Focus On Your Core Business Strategy 7/10/2025

    Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.

  3. Re-Engineering A Complex Process For FDA Compliance 8/21/2024

    Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

  4. Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges 8/21/2024

    Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

  5. Expanding The OSD Toolbox: An Industry Approach To Adsorb Lipids Onto Powder Substrates 12/11/2024

    Explore innovative solutions for improving the solubility and bioavailability of poorly soluble compounds in solid oral dosage forms to enhance drug delivery and therapeutic effectiveness.

  6. Overcoming Excipient Risks And Challenges For Parenteral Formulations 8/27/2025

    Excipients are essential to parenteral formulations, which help protect APIs, enhance stability, and ensure safety. Learn how strategic excipient selection can optimize drug performance and patient outcomes.

  7. Streamlining Analytical Release Testing With Faster, Smaller Workflows 10/28/2025

    Reducing turnaround times and sample volumes in release testing can accelerate cell therapy manufacturing, preserve product yield, and improve patient outcomes.

  8. Formulation Through Manufacturing Under One Roof 2/18/2025

    Partner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.

  9. Mild pH Protein A Purification Step With A Mild Elution Resin 5/22/2026

    As antibody formats diversify, low-pH protein A elution can drive aggregation and yield loss. Learn how milder elution conditions during capture can help protect sensitive molecules and ease challenges.

  10. Overcoming API Constraints And Tight Timelines With On-Demand Manufacturing 3/20/2026

    Use innovative lipid-based formulations and on-demand manufacturing to accelerate Phase 1 trials, enable flexible dose escalation, and maximize limited API for poorly soluble compounds.