Industry Insights

  1. Pharma Liquid Filling Systems — Comparison And Selection Guide

    Having sold filling lines for all types of liquid pharmaceutical products (hundreds of lines in aggregate), Bosch Packaging Technology is in a unique position to advise on filling system selection.

  2. 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.

  3. Complex Molecule Development: Early Considerations To Avoid Failing Later?

    How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.

  4. Getting Ready For Phase 1 In Pharmaceutical Development

    At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.

  5. A Consultant's Guide To Flexible Biomanufacturing Solutions

    Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. 

  6. 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.

  7. The Importance of Proactive Clinical Returns Planning

    Help sponsors design a more holistic strategy to their managing the clinical supply returns process.

  8. The Changing Biopharma Risk Equation

    As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product—ranging from well-established large molecule drugs to truly novel therapies—poses major challenges because of their scientific complexity and sophisticated development requirements.

  9. Divergent Approaches To Stem Cell Regulation

    Cell-based therapies are a challenge to regulators as they involve withdrawing cells from a patient’s bone marrow, blood or tissue, growing cells in vitro, and administering the expanded cells into the patient.

  10. Finding Solid Ground In New Markets

    In the recent Economist Intelligence Unit survey on biopharma’s present and future, biopharma industry leaders expressed excitement and some uncertainty about the emerging markets of the Middle East and Africa. Respondents saw great opportunity in these regions, but also cited potential risks in relation to regulatory questions and stability issues. We spoke with Bert de Vet, Head of Commercial EMEA Process Solutions at MilliporeSigma, about his take on growth in the region and some of the ways companies entering these regions can mitigate risk.