Outsourced Pharma White Papers

  1. Navigating The Adoption Of Continuous Pharma Manufacturing 3/1/2021

    Driving a path forward for continuous manufacturing calls for a closer look at current global challenges, any existing barriers, and the ideas and initiatives necessary to fulfill its potential.

  2. 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.

  3. Remote Access And Monitoring Of Bioprocess Unit Operations 5/26/2022

    Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.

  4. 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.

  5. Components Of An Effective Disinfectant Prequalification Strategy 1/24/2022

    Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

  6. How Dwell Volume And Extra-Column Volume Impact Method Transfer 9/22/2022

    Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.

  7. Navigating The Regulatory Maze: Fundamentals For Drug Development 7/15/2022

    Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey. 

  8. Accelerating The Development Of Orphan Drugs For Rare Diseases 4/18/2022

    Explore four principal CMC challenges for the developers of orphan drugs and the potential emerging solutions.

  9. Rational Design & Development Of Lipid- Filled Hard Capsules 1/26/2022

    With the increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based drug delivery systems have become an important tool for formulation development.

  10. Steps To Successfully Complete An FDA Inspection 6/20/2022

    We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.