Industry Insights

  1. 5 Questions To Answer Before Starting Your CMO Search

    Without careful consideration of what are the most important features you need from a CMO and preparing for what the CMO needs from you, the result can be a mismatch.

  2. The LAL Test: Precautions When Conducting Pharmaceuticals Research

    For many decades, it has been found that the most effective method for determining pyrogens in pharmaceutical samples, regardless of the form of the active substance, is the LAL test. 

  3. Important Considerations For Lab Scale Protein Purification

    Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. At the larger end of the scale, advances in upstream processing such as improved fermentation capacities have led to increased amounts of crude sample available for input. Despite this meaning higher potential yields of target proteins, it also poses an enormous challenge for timely and cost effective sample processing further downstream. This challenge is made even more difficult as scale increases due to higher amounts of impurities — a result of prolonged fermentation times and higher cell densities in large-scale cell cultures.

  4. Process Simulation And Its Benefits

    Philip Lyman, PhD – Director of Process Simulation at CRB – discusses how a process model, at the right detail level and properly validated, can be an invaluable tool to compare alternatives and justify cost for manufacturing and manufacturing-related processes.

  5. Pharmaceutical Primary Packaging Strategies

    When a clinical trial progresses, the formulation itself and the dosage form may change. As a result, sponsors may also want to consider the desirable commercial format in later stage clinical studies.

  6. Tips For Performing Preparative Chromatography And Protein Purification

    This articles provides some fundamental tips and tricks to preparative chromatography that will yield a pure sample preparation that will advance protein characterization studies.

  7. Phase II And Phase III Studies Standard Protocol A Template For Success?

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.

  8. How Do You Inspect Packaging Of Bottles, Cans And Cylinders?

    To ensure the package is error free, progressive companies now use automated proofreading solutions throughout the design and printing of the package and label.

  9. Bacterial Endotoxins As Contaminants Of Therapeutic Proteins

    The impurities of a therapeutic protein might be similar molecules obtained as part of the protein biosynthesis, or might come from the cellular substrate used in its production or from the production process itself.

  10. Is Your Complex Formulation Process Set Up For Success?

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.