Outsourced Pharma App Notes & Case Studies

  1. How To Integrate Automation In Your Biomanufacturing Environment

    Through proper planning of your automation integration, you can eliminate costly errors and missteps and focus on developing efficient, future-proof automation strategies.

  2. The Transparent CDMO: Maintain Autonomy In Biomanufacturing Partnership

    Complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

  3. Complex Molecule Development: Early Considerations To Avoid Failing Later

    How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time to market.

  4. Comparing Continuous And Batch Processing In Downstream Purification

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

  5. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis

    Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how surface plasmon resonance has been applied for protein characterization of antibody effector function.

  6. Embracing Biosimilars, They Are Here To Stay

    The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.

  7. Does Selecting A CDMO Based On Contract Price Really Save You Money?

    Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

  8. Multidimensional Scale-Up Of A mAb Capture Step Contributes To Shortened Time To Market

    This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.

  9. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  10. Extractables And Leachables Studies Support Single-Use Systems

    Concerns about leachables were expected to restrict adoption of single-use systems. This case study shows how far they’ve come.