Industry Insights

  1. How To Use QbD Software To Improve An Existing Identification Method

    What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.

  2. Key Considerations When Sourcing Reference Products For Biosimilar Studies

    In order to ensure a smooth development and clinical process, companies must carefully plan their activities with regard to the innovator biopharmaceutical. 

  3. Who You Should Involve When Purchasing A Biosafety Cabinet

    While purchasing decisions necessarily involve management, servicing, and engineering teams, it is advisable to include the people who will use the technology in the selection process.

  4. Why Early Investment In A Scalable Manufacturing Process Is Critical

    The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.

  5. Streamlining Recombinant Protein Production

    Bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.

  6. The Multivariate World Is Expanding For Research And Industrial Data Analysis

    While the multivariate research toolbox is well established and ever increasing, its industrial counterpart - chemometrics - is only beginning to see widespread use in the last decade.

  7. Humidity Definitions

    Relative humidity is the ratio of two pressures: %RH = 100 x p/ps where p is the actual partial pressure of the water vapor present in the ambient and ps the saturation pressure of water at the temperature of the ambient.

  8. Overcoming The Problems Of Transferring Tablets And Capsules

    Key factors that must be taken into consideration to achieve efficient material handling without damage to the finished product.

  9. Is Selecting A CDMO Based On Contract Price Really Saving You Money In The Long Run?

    Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

  10. Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off

    Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.