Outsourced Pharma App Notes & Case Studies

  1. Zydis® ODT - Improved Therapeutic Profile

    Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.

  2. Medium Preparation For Single-Use Fermentation

    To overcome many of the challenges associated with stainless steel vessels, single‑use fermentors offer an increasingly viable alternative. 

  3. Advancing Vaccine Development
    With extensive experience in vaccines development, as well as market access and commercialization strategy, Quintiles is uniquely qualified to be your ally in vaccines.
  4. Thermoinducible Expression Of DNA Polymerase I

    Thermo Scientific HyPerforma Single-Use Fermentor is a unique, robust, and purpose-built solution for microbial fermentation applications, offering flexibility, and efficiency found in single-use systems. 

  5. A Global Forum For Outsourcing (With Simple Objectives)

    Perhaps the best advice I’ve heard regarding industry conferences is twofold: first, make sure you attend, and second, keep your objectives for attending simple.

  6. Does Your Pharma CMO Deliver On Its Promises After Being Acquired?

    I first met Mark Bamforth, the president and CEO of Gallus BioPharmaceuticals, at a conference shortly after he had acquired/founded his CMO in St. Louis. The company was so new many of the employees at the event didn’t even have business cards.

  7. The Critical Importance Of Comparator Temperature Excursion Management

    Today, comparator procurement is one of the most expensive components of clinical trials. This cost can take on further meaning as the risk of a temperature excursion or a loss of drug due to time out of environment can result in additional charges and even delays in the trial.

  8. Planning The Execution Of A Viral Clearance Study

    Viral clearance studies are done to evaluate a purification process’s capability, or to remove/neutralize viruses that can contaminate a starting material in regulatory submissions in clinical trials. The complexity of these studies means that they typically require significant financial and scientific expertise to perform. Because of this, if a viral clearance study isn’t done right the first time, costly delays are all but inevitable.

  9. Six API Challenges And How To Avoid Them

    Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.

  10. Cost Savings And Speed: The Untapped Value Of A Single-Source Solution

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