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

1. Understanding The EU Regulatory Landscape For Cell And Gene Therapies 4/9/2026

   EU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.

2. A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation 1/15/2025

   Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

3. When To Consider Material And Personnel Airlocks For Downflow Booths 3/20/2026

   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.

4. Why RWD Strategy Can't Wait With Price, Value And Evidence Pressures Everywhere 4/27/2026

   Overcome pricing pressures and reimbursement delays by integrating real-world evidence early in development to align clinical outcomes with payer demands and accelerate patient access.

5. Delivering A Registrational GI Trial Through Ongoing Protocol Shifts 10/17/2025

   A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.

6. A Temperature-Stable Replacement For Animal Trypsin In Cell Dissociation Applications 6/9/2025

   Improve cell dissociation with a gentle, recombinant enzyme. This temperature-stable protease shows dissociation kinetics similar to porcine trypsin but with lower cell toxicity and greater overall purity.

7. Improved Cell Viability For Multi-Day Cell-Based Assays 7/24/2025

   Ensure consistent cell health and assay reliability with controlled temperature and gas conditions. Discover how microplate readers with gas mixers enhance cell viability in live cell-based assays.

8. Engineering Precision In Genetic Medicines 9/22/2026

   Explore how protein discovery, PAM engineering, and AI-guided optimization can expand target coverage, improve editing specificity, and address challenging therapeutic applications.

9. The Value Of Human Panel Testing Downstream Of Donor Screening In The Allogeneic Therapy Pipeline 3/31/2025

   Allogeneic cell-based therapies require rigorous donor screening for adventitious viruses. qPCR-based assays enhance detection accuracy, sensitivity, and specificity, supplementing serological testing to ensure safer drug development and production.

10. Next Generation Sequencing In Viral Safety Testing 7/25/2025

    Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.