Industry Insights

  1. Avoid The Fallout From Incompatibility Between Your API And Its Formulation

    It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.

  2. Operational Excellence In a Flexible Manufacturing Environment

    By thinking outside of the box, CDMOs can create a flexible and scalable business model that offers a level of assurance in the face of forecast variability.

  3. Early CMC Work Sets Groundwork For Regulatory Success

    Understand how the more support and guidance small biopharmaceutical companies receive in terms of CMC expertise, the better groundwork it will lay for a successful IND filing.

  4. 5 ADC Manufacturing Challenges You Need To Know

    Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.

  5. Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?

    A company has to be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.

  6. Powerful Tools For Downstream Process Development: Mixed-Mode Resins/Multimodal Chromatography

    With their unique separation behaviors and tolerance for relatively high salt concentrations, mixed-mode resins have become important tools in the process developer’s toolbox.

  7. Strategies for Efficient Clinical Supply Management and Forecasting

    Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.

  8. Cold-Chain Fully Automated Assembly And Labeling Of Pre-Filled Syringes

    Cold is undeniably the new normal for the biopharmaceutical industry. By 2020, greater than half of bestselling drugs will be cold-chain products, most of which are injectable.

  9. Clinical Supply Chain Transformation Through Innovation

    Even with forecasting and building out a sizeable buffer inventory, clinical sites may still not always have the appropriate kits on hand to dispense to patients. Why?

  10. Introduction to Chromatography for Protein Purification

    Whether these proteins are produced by recombinant DNA technology or extracted from sources such as plasma, they need to be highly purified — and the purification process must satisfy a variety of regulations.