Industry Insights

  1. The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. 

  2. 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.

  3. Keeping Up With Viral Safety Trends In Bioprocessing

    Understand the new technologies and methodologies that are emerging for both producing and testing biopharmaceuticals as the industry is entering a new era of viral safety assurance.

  4. 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.

  5. An Efficient Purification Platform For Recombinant Proteins

    Mixed-mode chromatography matrices are designed to present multiple interaction modes to resolve target proteins and impurities, entities that are themselves complex multimodal molecules. 

  6. Don't Be A Daredevil When Retrofitting Your Facility

    With mergers/acquisitions and cost-cutting initiatives, facilities are being shut down and product lines consolidated into existing facilities—risking sub-optimal layout and design.

  7. Implementing A Total Quality Strategy In Life Sciences

    According to over 200 life sciences companies surveyed, the number one challenge in speeding products from R&D to patients is quality management, which may surprise many executives that have spent the past decade focused on other issues like validation, regulatory, or supply chain.

  8. 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.

  9. The Future Is “Cloudy” For Data Integrity In Life Sciences

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.

  10. Streamlining Recombinant Protein Production

    Bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.