04.03.26 -- STREAM Edition: Trends In FDA FY 2025 Warning Letters

Flow cytometric phenotyping is crucial for immunotherapy to enable precise immune monitoring. Discover how standardized assays with an 8-color cocktail enhance the understanding of tumor immunity.

Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.

Accurate cleanroom particle monitoring requires precise isokinetic sampling. Understand how to maintain sampling accuracy and meet regulatory airflow requirements for your facility.

Laboratories drive innovation, but their environmental impact is growing. Review five practical tips to make your lab more sustainable to reduce waste and support global climate goals.

Find out how diagnosing ribosome pausing sites and optimizing codon usage dramatically improves bispecific antibody titers, turning difficult-to-express candidates into viable therapeutics.

Stop chasing missed pull windows caused by disconnected spreadsheets. Centralized, automated systems ensure regulatory compliance and keep your critical stability studies on track today.

Understanding library size distributions helps prevent sequencing through the insert, reducing adapter read‑through. See how smear analysis guides optimal read‑length selection to avoid noise.

OT cybersecurity can lag in many industries, but life sciences teams take a proactive approach. Their focus on confidentiality and integrity reshapes how risk and protection are prioritized across operations.

Move beyond general detection toward targeted risk assessment. Identify problematic impurities that impact drug stability and learn to standardize your analytical control strategies.

Uncover how a rapid digital PCR workflow enables reliable detection of trace RCL levels while maintaining strong performance in complex samples, which support more confident decisions.

Watch how integrated immune profiling reveals biomarkers and mechanistic insights into toxicity and treatment response, driving advances in cell therapy and personalized immunotherapy strategies.

Read about how Annex 1 applies to low bioburden DS manufacturing and promotes a risk-based approach to contamination control that balances regulatory compliance with operational efficiency.

Streamline proteomic workflows with consistent sample preparation. Observe how simplifying LC-MS processes can eliminate bottlenecks, improve reproducibility, and accelerate drug discovery research.

Discover a guide that helps regulated organizations choose and implement systems to boost compliance, efficiency, and asset reliability across operations.

Learn how mammalian display enhances T cell receptor-based cancer therapies. This method improves antigen affinity and reduces immunogenicity for more effective treatments.

Overcome LNP upscaling challenges by leveraging fluid mechanical principles. See how Impingement Jets Mixing achieves reproducible turbulence and consistent LNP quality across all production scales.

Middlesex County, NJ, offers life sciences organizations a deep talent pool, an extensive R&D presence, and dedicated backing by local government investment.

Reveal a solution for streamlining workflow in novel biologics while collecting quality data, by combining single-use microbioreactors with advanced automation and analytical platforms.

Examine strategies to improve the performance of IB processes, as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

Agentic AI is reshaping how FDA review, surveillance, and inspection activities operate, raising the bar for expectations. Gain insight into how these changes will redefine regulatory engagement.

Annex 1’s updated CCS framework calls for a holistic contamination strategy. Find out how manufacturers can apply it to non-sterile sites and legacy facilities using tailored risk-based approaches.