Outsourced Pharma White Papers

  1. Continuous Manufacturing And Late-Phase Strategy: The Time Is Now 5/17/2022

    Explore recent progress in continuous manufacturing and guidance for answering key questions related to implementation of continuous processing for late-phase development.                             

  2. Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway 1/26/2022

    Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

  3. Comparator Local Sourcing Strategies: Avoiding Pitfalls For Clinical Trials 6/3/2022

    The growing demand for comparators is causing many supply chain managers to explore available sourcing options. Explore alternative local sourcing strategies, including advantages and disadvantages.

  4. Making The Right Decisions Upstream To Ensure Downstream Success 5/12/2022

    Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.

  5. FDA Designations for Rare Disease Products: A Complete Guide 8/27/2021

    This paper highlights the designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Explore the criteria, timeline and maintenance, and benefits of each designation.

  6. Assessing End-To-End Drug Development Partnerships 1/24/2022

    As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.

  7. Effects Of The Ongoing Pandemic On Bupivacaine HCI Supply 1/20/2022

    Throughout the pandemic, painkiller and sedative demands have spiked. Drug manufacturers and CDMOs have become critical in efforts to stabilize the supply of Bupivacaine HCl and other essential drugs.

  8. Why More Drugs Than Ever Are Approved Through 505(b)(2) 6/6/2022

    Discover how bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity.

  9. The Digitalization Of Biopharma Process Development, Manufacturing 8/30/2022

    The fourth industrial revolution is coming. Explore the three essentials of bioprocess development and manufacturing digitalization: digital literacy, digital trust, and prioritization.

  10. Considerations In Formulation Development Of Injectable Solutions 2/8/2022

    Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.