Industry Insights

  1. Prepare For An FDA Bioburden Inspection

    A former FDA Biologics License Application reviewer and inspector focusing on microbiology, shares expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.

  2. There’s No Such Thing As A “Perfect Blend” – Uniformity Factors In Pharmaceutical Mixed Powders

    Identifying the many factors that factor in when trying to obtain the perfect blend for your powder formulation.

  3. What You Need To Know About Continuous Processing

    There is a lot of interest around continuous biomanufacturing, but could a hybrid of batch and continuous unit operations be the best solution for your process train?

  4. Expand Capacity In Buffer Management

    Biomanufacturing requires large volumes of buffers, and preparation of these liquids can quickly become a bottleneck. Here, two options that can help intensify your large-scale buffer management are presented.

  5. Using Flow Sensors As Diagnostic Tools In Pharmaceutical Manufacturing

    Investigating the source of this consumption increase early on and correcting the problem will improve the performance and uptime of all automated plant equipment.

  6. Tablet Compression Tooling Maintenance 101

    “How long should a set of tools last?” is one of the most common questions asked of tooling vendors. The answer is dependent on many factors.

  7. A Call To Action: Industry Innovators Seek New Technologies To Advance Personalized Medicine

    Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing. 

  8. The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing

    How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?

  9. Translating Biopharma Knowledge To Cell And Gene Therapies

    Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

  10. Build Efficiency Through Continuous Characterization

    Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.