Industry Insights

  1. Optimizing Titer and Use of a Specific Enzyme for Generating a Fully Processed Antibody

    An outline of the cell development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.

  2. Tips On Downstream Purification Processes

    Once protein purification work surpasses a certain scale in terms of volume, a measured and step-wise development of the bioseparation process is vital.

  3. Why Early Investment In A Scalable Manufacturing Process Is Critical

    The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.

  4. Future-Proofing Your Single-Use Biomanufacturing Capacity

    The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But you need to consider your long-term needs.

  5. The Key To Unlocking Foreign Pharmaceutical Markets

    The opportunities in developing global markets appear limitless, but the obstacles surrounding them can be daunting. With issues ranging from language barriers to protecting intellectual property rights, each solution must be as unique as the country the work is developed in. Download this eBook to learn key strategies to unlock foreign pharma markets.

  6. Driving Change of Implementing In-Line Conditioning

    The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.

  7. How Global Pharma Orgs Can Achieve Process Validation Success

    There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary.

  8. Single-Use Technology: The Next 5 Challenges to Conquer

    While single-use processing has limitations with scale of operations when compared to stainless steel setups, several trends are mitigating the impact of these limitations significantly.

  9. Important Considerations For Lab Scale Protein Purification

    Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. 

  10. 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.