Industry Insights

  1. Implications Of Inaccurate Forecasting On Biologics Manufacturing

    Inaccurate demand forecasts can have significant implications for companies developing biologics. And, it is increasingly difficult to locate capacity to respond to demand changes.

  2. Meeting The Challenges With Complex Biomolecules In Modern Vaccinology

    Vaccine development and manufacture is one of the most challenging tasks within biopharmaceuticals today.

  3. Can Assumption-Free Batch Modeling Eliminate Processing Uncertainties?

    Monitoring batch processes to ensure the highest level of quality is imperative. While periodic batch process control is the traditional approach to managing consistency end quality, it is recipe-driven. 

  4. Critical Factors Of Fill/Finish Manufacturing For Biologics

    Unlike small molecule drugs, biologics are extremely sensitive, and therefore require specific handling procedures throughout the manufacturing process.

  5. 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.

  6. Cost Savings And Speed: The Untapped Value Of A Single-Source Solution

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.

  7. Comparing Culture Methods In Monoclonal Antibody Production

    Recombinant protein manufacturing with Chinese hamster ovary (CHO) cells represents over 70% of the entire biopharmaceutical industry.  In fact, human monoclonal antibodies (hMAbs) produced by CHO cells have played a major role in both the diagnostic and therapeutic markets for decades.

  8. Expanding Single-Use Biomanufacturing Into New Locations

    If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.

  9. 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.

  10. Which Test Is Appropriate For Container Closure Integrity?

    Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.