Cell And Gene Articles, App Notes, Case Studies, & White Papers

1. Streamline Analytical Tech Transfer Through Analytical Target Profile 9/9/2025

   Analytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.

2. Select The Best Analyte: A Guide To Effective Mycoplasma Testing 9/24/2025

   As you build a Mycoplasma testing strategy to ensure drug safety, there are three analyte types to choose from: live Mycoplasma, RNA, and genomic DNA, each offering distinct advantages.

3. The Value Of Peptones For Enhancing Biopharmaceutical Productivity 11/18/2024

   Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.

4. A Study To Assess Organoid Size And Cell Count From 3D Image Analysis 4/4/2025

   Recent advancements in 3D patient-derived organoids (PDOs) offer improved predictive power over traditional 2D assays. Explore a patented bioprocess for PDO expansion that could revolutionize drug discovery, especially in oncology.

5. A Beginner's Guide To Sf9 Culture In Stirred-Tank Bioreactors 7/9/2025

   Learn about the workflow steps for Sf9 cell expansion, virus preparation, and protein production in stirred-tank bioreactors, including GFP expression.

6. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

   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).

7. Functional And Phenotypic Characterization Of Human NK Cells Post-Expansion 9/10/2025

   A new method for expanding natural killer cells provides a way to generate a large quantity of potent cells for clinical applications. This approach maintains key cell functions and killing ability.

8. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

   Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

9. Optimizing siRNA Therapeutics: Addressing Manufacturing Complexities 3/21/2025

   Discover key strategies to optimize siRNA therapeutics by addressing critical nonclinical and manufacturing challenges for a smoother path to commercialization.

10. Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals 6/6/2024

    VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.