Insights On Facility Design

  1. Lessons From FDA 483s And Warning Letters: Cleanroom Compliance 12/8/2025

    Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

  2. Optimizing Monitoring: The Science Of Particle Loss 11/26/2025

    Explore how tubing configuration impacts particle recovery and compliance under Annex 1, using evidence-based guidance, risk assessment tools, and practical strategies to strengthen contamination control.

  3. Streamlining pDNA: Capacity, Complexity, And Cutting-Edge Solutions 11/20/2025

    Learn how flexible facility design and process innovation are accelerating pDNA manufacturing, as well as key strategies to avoid scale-up pitfalls and meet growing therapeutic demand.

  4. Lessons In Scaling Regenerative Medicine Manufacturing With Organogenesis's Patrick Bilbo 11/18/2025

    In this episode of "Better Biopharma," Tyler Menichiello is joined by Patrick Bilbo, chief operating officer at Organogenesis, a regenerative medicine company developing and manufacturing advanced wound care products.

  5. Key Considerations When Selecting A Laboratory Incubator 11/17/2025

    Choosing the right incubator requires more than reading specs. Learn how to evaluate performance metrics, contamination control, and real-world functionality to make confident equipment decisions.

  6. Automated Bioburden Testing Solution 11/7/2025

    Automation is transforming microbial quality control labs, boosting productivity, minimizing errors, and ensuring data integrity. Discover how digitalization is driving Pharma 4.0 and reshaping lab workflows.

  7. A Universal Workflow Approach For Single Cell Mass Spectrometry Based Proteomics 11/7/2025

    Learn about a streamlined workflow that improves reproducibility, reduces contamination, and simplifies single-cell proteomics with comparable results to FACS.

  8. Build An AAV8 Platform: Lessons From A Collaborative Development Journey 11/5/2025

    Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

  9. Cell Culture Media Manufacturing, Paisley, Scotland 11/4/2025

    Learn more about our cell culture media manufacturing global network, including details of the Paisley, Scotland site's capacity expansion supporting the bioprocessing industry's rapidly growing needs.

  10. Cell Culture Media Manufacturing, Grand Island, NY 11/4/2025

    Learn more about our cell culture media manufacturing global network, including details of the Grand Island, New York sites capacity expansion supporting the bioprocessing industrys rapidly growing needs.