Industry Insights

  1. Reducing Upstream Processing Scale-Up Risks Using QbD

    Upstream process must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance.

  2. The Relationship Between The Chemical Nature Of Bacterial Endotoxins And Their Toxicity And Immunogenicity

    The diseases related to Gram-negative bacteria affect humans and animals and, in many cases, are difficult to treat, which is why is important to have effective and bacteria-specific antibiotics.

  3. Site Selection And Development Utilizing A Colored Stop/Go Rated Matrix

    How to incorporate a new process into an existing facility is a basic question that begins every project. The client usually has a preconceived idea of where a new process will go and how much space is available, but if we stop here and do what we are told, preconceived notions may drive us to a point where we find that project needs haven’t been met.

  4. 12 Ways To Reduce Data Integrity Risk

    It is important to understand what data integrity really means in order to be compliant. Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle.

  5. Critical Opportunity For Pharmaceutical And Process Understanding

    Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.

  6. Reducing Analytical Method Steps For Accelerated Product

    With an increasing number of products being considered for accelerated development, both the industry and regulators are looking for ways to safely hasten product development and approval times to ensure availability of innovative and low-cost drugs for patients.

  7. Why The Shift From Batch To Continuous For Pharmaceutical Oral Solid Manufacturing Is Now Upon Us

    There has been intense interest and emphasis being given to the continuous OSD manufacturing process as an alternative or addition to the traditional batch manufacturing process. 

  8. 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?

  9. 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.

  10. Solutions To Today’s Biomanufacturing Challenges

    With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to today’s challenges.