CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• When To Consider Material And Personnel Airlocks For Downflow Booths

  Strategic use of airlocks in downflow booth design enhances pressure stability and containment. A risk-based approach ensures facility integration meets rigorous safety and compliance standards.

• Manufacturing ADCs: Extractables In Single-Use Systems

  Antibody-drug conjugates offer targeted cancer treatment with reduced toxicity. Discover how single-use technologies simplify ADC manufacturing to ensure safety, flexibility, and efficiency.

• Enabling MSC Harvest, Wash, And Concentration

  A study demonstrates how a low-shear, closed-system centrifuge achieved over 90% MSC recovery and minimized viability loss, supporting scalable cell therapy manufacturing.

• Navigating CMC Regulation For Plasmid DNA In Gene Therapy

  Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

• Yeast Extracts: Improving Expression

  Yeast extract improves E. coli protein production by over 50%, boosts desired protein attributes 4X, and offers a secure animal-free nutrient source.

• The Proven, Practical Gateway To Upstream Process Intensification

  N-1 perfusion enables higher inoculum densities, faster production, and reduced costs without altering fed-batch processes. Explore a practical path to intensification for biologics manufacturers.

• AAV Viral Titering Using Nanoplate-Based Digital PCR

  Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

• Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ

  The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

• Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?

  Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.

• Transforming PSP Enrollment To Enhance User Experiences And Optimize Workflows

  Lengthy enrollment calls burden patients and PSP teams alike. See how a digital-first intake approach cut onboarding time and improved outcomes for everyone involved.