12.12.25 -- Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up

Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

Hear from a 21 CFR Part 11 expert with nearly 20 years of experience supporting pharmaceutical, diagnostic, and med device companies with implementing solutions and systems to ensure compliance.

Future submissions are expected to align with FDA's draft guidance that clarifies its expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

Waiting to integrate GMP can lead to time delays and unnecessary costs. A new approach to phase-appropriate GMPs can help manufacturers navigate today's regulatory landscape with confidence.

The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

Explore how Isothermal Titration Calorimetry (ITC) precisely analyzes molecular interactions, which provides crucial thermodynamic data to understand physiological processes and develop new therapeutic strategies.

Find out how to achieve reliable IVT mRNA quality. Learn the best practices for precise analysis, including proper sample prep and system optimization for high-resolution results.

Explore how a holistic approach to single-use system integrity can strengthen contamination control, improve operational efficiency, and meet evolving regulatory expectations in manufacturing.

Life sciences manufacturers are integrating QA, QC, and production to boost efficiency, reduce downtime, and scale smartly. Discover how Industry 4.0 technologies are reshaping operations.

Explore how software-defined manufacturing is helping companies overcome legacy system challenges, improve OEE by up to 25%, and accelerate batch release cycles while maintaining compliance.

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

Explore innovative strategies in process intensification to boost mAb production and hear from industry experts as they share solutions for scaling efficiency and navigating regulatory challenges.

In this study, a fully automated workflow utilizing the BD FACSDuet™ Sample Preparation System integrated with the BD FACSLyric™ Flow Cytometer was assessed and compared to manual processing.

Learn how to design, normalize, and interpret replicate western blot experiments to ensure reproducible protein quantification with fold change calculations, CV analysis, and visualization strategies.

Learn how real-time monitoring and PAT platforms can streamline bioprocessing, reduce testing delays, and improve decision-making across upstream and downstream workflows.

Review regulatory expectations for pharmaceutical QC release testing and which characterization analytics are anticipated to be required to comprehensively characterize mRNA-LNP products.

Manufacturers can cut emissions and boost efficiency by modernizing energy and utility systems. Explore how smart automation and analytics offer fast ROI and long-term sustainability.

Discover how MMS quantifies peptide concentrations and identifies structural differences in GLP-1 and its commercial analogues across various buffer systems.

Discover how ultra-sensitive digital PCR workflows use an innovative system to enable precise detection of rare PIK3CA mutations in cfDNA and advance personalized cancer treatment.

Precision in nanoparticle processing is key for drug delivery and vaccines. Learn how monodispersed formulations enhance reproducibility and stability for next-generation therapeutics, like RNA-LNPs.

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.

Urine-derived cell-free DNA is revolutionizing liquid biopsy research to offer a non-invasive, accessible tool for early disease detection, monitoring, and comprehensive diagnostics across oncology.

Discover the vital yet often unseen role of CDMOs in manufacturing by exploring their validation challenges, regulatory demands, and strategies for maintaining quality, speed, and innovation.

Automated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.

Evaluating quality attributes of therapeutic proteins requires a strategic, regulation-compliant selection of analytical techniques that consider molecular characteristics and phase to ensure characterization.

Stop the cycle of paper-based errors and batch record delays. Learn how a modular, compliance-first manufacturing system accelerates validation, enables real-time traceability, and shortens release cycles.