Outsourced Pharma White Papers

  1. Analyzing Product Formulation Using Raman Microscopy 10/26/2020

    Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.

  2. Top 8 Obstacles In Pharma & Biologics Products Registration & Submission Management 8/24/2021

    Life science organizations can’t afford any delays in product registrations and overall time to market. As with many industries, time is money. There are a variety of obstacles that result in delays to registrations, many of which can be avoided using sound business processes and leveraging technology to automate processes. Here we identify some of the most common problems below and share some insights on how best to address them.

  3. Making The Medicine Go Down: Specialized Delivery Technologies 10/7/2020

    While most oral solid formulations are designed to release the drug immediately after swallowing, some products have been developed to provide a “controlled-release” of the drug products.

  4. Placing Drug Strategies On A Solid Foundation For Success 4/21/2022

    Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

  5. Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing 6/1/2022

    Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.

  6. 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.

  7. Accelerating Cell Line And Process Development 8/27/2020

    This paper describes rapid identification of high-producing cell lines, media feed optimization, and a bioreactor scale-up approach for consistent, reliable upstream bioprocess development.

  8. Assessing The Financial Impact Of Translational Pharmaceutics® 3/3/2022

    Examine an innovative approach to accelerating drug development, and learn the savings to drug developers from applying the approach across the industry portfolio of investigational drugs.

  9. Leveraging Innovations In Plasmid Manufacturing 5/17/2022

    Explore the market trends influencing the manufacture and supply of pDNA for advanced therapies and the key challenges associated with transitioning from GMP-like to full cGMP quality.

  10. The Advantages And Challenges Of Fixed-Dose Combination Products 1/20/2022

    Understanding the significant competitive advantages of FDC products and the difficulties and potential pitfalls associated with their development and manufacturing in oral solid dosage forms is critical.