Industry Insights

  1. What Water Treatment Advancements Mean For Pharma

    Pharmaceutical water is key to the production of pharmaceutical drug products, and there have been a number of technological advancements in high-purity pharmaceutical-grade water.

  2. 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.

  3. Keys To Successful Implementation Of Single-Use Technology

    How and why collaboration improves single-use products.

  4. Comprehensive Solutions For Aggregate Issues

    Aggregate molecules are mostly physically and chemically similar to monomers, their presence in the final purified product, especially a therapeutic mAb, is undesirable due to multiple reasons. 

  5. Speaking The Regulatory Language

    The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for MilliporeSigma, to explore the interplay of emerging markets and regulatory harmonization.

  6. Bacterial Endotoxins As Contaminants Of Therapeutic Proteins

    The impurities of a therapeutic protein might be similar molecules obtained as part of the protein biosynthesis, or might come from the cellular substrate used in its production or from the production process itself.

  7. How To Drive Down Laboratory Operating Costs With SaaS

    This white paper explores best practices in SaaS selection and incorporation into laboratory practices that enable organizations to focus on their core competencies while utilizing best-of-breed software.

  8. Perfusion – Do’s And Don’ts To Cut Production Costs, Increase Efficiency

    Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach.  Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.

  9. Biosimilars Producer, Alvotech, Finds Opportunities In Iceland

    Alvotech's facility features a high-yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes,and end-to-end upstream/downstream automation. 

  10. Changes To The Opioid Labeling Regulation

    FDA is revising warnings and safety information for immediate-release (IR) opioid labeling. The goal is to inform doctors better about the risks of opioids and how to prescribe these drugs safely.