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

• 5 Steps To Design A Microbiological Performance Qualification For Facilities

  Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.

• Expansion Of Human Umbilical Cord-Derived MSCs

  Discover how high-quality, multipotent stromal cells are efficiently produced for regenerative medicine. Learn about their impressive viability and critical marker expression for therapeutic uses.

• 5 Must-Haves For Electronic Batch Records In Life Sciences

  Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.

• Collaborative Variability Reduction In Cell Culture Media

  Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

• Single-Use Assembly Capabilities To Keep Pace With Biopharma Dynamics

  Discover how a vendor-independent partner assists global life science companies and CDMOs with innovative single-use technologies to mitigate risks and ensure uninterrupted manufacturing.

• Strengthening cIEF Method Validation With cIEF-MS

  Preparing for method validation, a biopharma company needed to characterize cIEF charge variants and confirm peak identities for regulatory readiness.

• End-To-End Process Scalability Of HEK 293 Media For High Titer AAV Production

  Explore how controlled bioreactor environments enable optimization of critical process parameters and support robust, scalable AAV production from development through manufacturing.

• Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators

  Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

• NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission

  A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

• Ensuring Product Safety And Purity With Mycoplasma And Sterility Testing

  Discover how the Applied Biosystems™ MycoSEQ™ Plus system and Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System can help accelerate your cell therapy manufacturing process.