Outsourced Pharma App Notes & Case Studies

  1. Process Economy Of Using Cytodex Gamma Microcarriers
    8/3/2018

    Microcarriers are commonly used in bioreactor cultures to provide a large growth surface for anchorage-dependent cells, and are typically provided either untreated or gamma-irradiated and ready for use.

  2. Managing Risks To Time Critical Product Imports At Clinical Supply Depots
    6/11/2019

    Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.

  3. Improved Method for Determination of Adenovirus Concentration Using Surface Plasmon Resonance
    9/10/2018

    The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.

  4. Comparing Continuous And Batch Processing In Downstream Purification
    6/10/2019

    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. Accelerated Manufacturing Of Subunit Vaccines For A Rapid Pandemic Response
    8/3/2018

    This application note describes a process for rapid production of recombinant anthrax protective antigen (rPA) in short process time for the manufacture of an anthrax subunit vaccine.

  6. How To Integrate Automation In Your Biomanufacturing Environment
    8/24/2018

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

  7. An Innovative Solution To Flexibly Meet Unique Primary Packaging Requirements
    1/4/2018

    A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase III study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided that would accommodate the customer’s growing demands for clinical supplies.

  8. Model Extraction Studies Examined For Monoclonal Antibody In Prefilled Syringe
    1/22/2019

    It’s been more than 30 years since monoclonal antibodies (mAbs) were first licensed for clinical use. But product developers are still inventing novel ways to improve their safety and efficacy.

  9. Don’t Let Insufficient Data Undermine Your CMO & CRO Selection Processes
    2/2/2018

    Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision. 

  10. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis
    5/23/2019

    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.