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

• What FDA CRLs Reveal About Method Validation

  FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

• Benchmarking Filtration Performance Of TFF Cassettes

  Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

• Comparing Serum-free To Serum-Supplemented Media

  Reducing serum in vaccine manufacturing is a key consideration for lowering costs and improving supply security. We compare performance in serum-free versus serum-supplemented media.

• Extractables In Single-Use Systems Used In ADC Manufacturing

  To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

• The Value Of Peptones For Cost-Effective Vaccine Manufacturing

  Peptones offer a strategic solution to key biomanufacturing challenges by enhancing cell culture performance, improving yields, and reducing production costs.

• Expansion Of Cord Blood-Derived CD34+ Cells In A Hollow-Fiber Bioreactor With 10% Standard Cytokine Concentration

  CD34+ cells isolated from cord blood were expanded in a hollow-fiber bioreactor using a novel cytokine cocktail at one-tenth the standard concentration using a MSC-free coating strategy.

• The True ROI Of Decentralized Clinical Trials

  Gain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.

• Production And Clarification Of Lentiviral Vectors

  Explore scalable processes for lentiviral vector production and clarification at the 50 L scale, utilizing the CTS LV-MAX system and single-use bioreactors for robust gene therapy manufacturing.

• Cytokines For Ex Vivo Cell Culture

  Comparable T cell expansion and function between cytokine sources were demonstrated. Generated CAR-T cells showed robust cytotoxicity and lower exhaustion markers.

• Protect Your Columns And Your Peaks

  Learn how thoughtful filter selection can protect LC systems, improve protein recovery, and support reliable chromatographic results with key performance data and solvent compatibility insights.