Outsourced Pharma App Notes & Case Studies

  1. Are You Prepared For The Complexity Of Pediatric Drug Development?
    11/22/2017

    Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

  2. Cost Savings And Speed: The Untapped Value Of A Single-Source Solution
    9/7/2017

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success.

  3. 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.

  4. Top 5 Events That Can Impact Your Clinical Supply Chain
    4/10/2018

    Review practical solutions for “small changes” in the clinical supply chain that can wreak havoc if not planned for in advance.

  5. Extractables And Leachables Studies Support Single-Use Systems
    1/22/2019

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

  6. End-To-End Process For Oncolytic Adenovirus Production
    3/20/2019

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

  7. Use Of Sodium Hydroxide For Cleaning And Sanitization Of Chromatography Resins And Systems
    10/2/2018

    This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.

  8. Advanced Therapies: Reimbursement And The Impact Of Hidden Supply Chain Costs
    6/10/2019

    While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated.  In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.

  9. Are You Ready For The Future of Biomanufacturing?
    1/19/2018

    As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way. 

  10. Improved Bioavailability Of Trio Medicines In 12 Weeks
    2/26/2018

    Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.