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

• Rescuing A Global Program For NDA Success

  Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

• Meeting Annex 1: A Proactive Approach To Regulatory Compliance

  It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

• Scale-Up Approaches For Culturing Adherent Cells

  For successful scale-up, see how optimizing process parameters such as attachment methods, gassing, and agitation can help reduce cell environmental stress, ultimately improving productivity.

• Levers To Optimize The IVT Reaction For Increased mRNA Yield

  Mastering IVT yield requires balancing magnesium and nucleotide ratios. Learn how specific buffers and pyrophosphatase optimize mRNA synthesis for scalable, high-quality therapeutic production.

• Addressing Plasmid DNA Challenges In Large-Scale AAV And Lentivirus Manufacturing Using dbDNA

  Plasmid DNA supply and regulatory concerns constrain large-scale viral vector manufacturing. Here, we examine whether enzymatically generated dbDNA can deliver comparable rAAV and rLV production outcomes.

• Optimize DNA Clearance In High-Salt, GMP-Grade Purification Processes

  Efficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.

• Delivering An Early-Phase Autoimmune Trial Across Regions

  Why do autoimmune trials stall when patients already have working treatments? See how one rare rheumatology study adapted its strategy to keep early-phase enrollment moving.

• T Cells In Immunotherapies: The Key Progress Underway

  CAR-T therapies now make up 73% of active pipeline programs, yet solid tumors remain largely out of reach. Where is T cell immunotherapy headed next, and what does it mean for your pipeline strategy?

• Robust Database Characterizes And Optimizes Product Development

  Integrating material characterization data with process parameters accelerates drug development, reduces empirical testing, and strengthens regulatory compliance.

• How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows

  The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.