Industry Insights

  1. The Impact Of Waste On The Cost Of Quality In The Pharma Industry

    Waste has a significant impact on the cost of quality (COQ) — or more exactly, the cost of poor quality — in the pharmaceutical industry.

  2. Useful Tips For Fab Protein Purification

    While protein purification is a well-established, conventional and highly trusted discipline, the approaches it employs can be as diverse as its targets.

  3. 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?

  4. 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.

  5. Prepare For An FDA Bioburden Inspection

    Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.

  6. Selecting The Optimal Resins For Adenovirus Process Purification

    The number of gene therapy–based treatments has grown significantly since they first appeared nearly three decades ago. This has created profound optimism about our potential to develop a cure for diseases such as cancer and AIDS.

  7. Freezing Down Time In Bioprocessing

    Can high density cryopreservation allow biopharma manufacturers to buy back time? The answer is “yes” – and specialized media (both catalogue and customized) for perfusion processes are being designed for this purpose.

  8. From Outsourcing To Partnership

    A recent survey by the Economist Intelligence Unit questioned biopharma industry leaders about their plans and concerns for the future. Along with excitement over expanding into novel therapies and emerging markets, they expressed serious concerns about risk mitigation. To combat risk, they raised the potentially contradictory options of building internal capacity and using outside experts. We spoke with Sebastien Ribault – Director of the MilliporeSigma BioDevelopment Center – to get his take on this duality and how it’s changing the nature of partnership.

  9. Different Environments Where Bacterial Endotoxins Can Be Found

    They are many environments that may be contaminated with bacterial endotoxins or lipopolysaccharides as they are also known, since Gram-negative bacteria are characterized by their great level of ubiquity.

  10. Digitally Transforming Laboratory Operations

    “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.