05.29.26 -- The Burden Of Proof Has Shifted To Analytics For Biosimilar Approval

In GMP operations, poor asset control quickly becomes a compliance risk. Discover how maintenance and calibration gaps lead to deviations and why demonstrable asset performance is essential.

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.

Homogeneous ADCs demand precise conjugation chemistry. See how 100% ncAA incorporation and 15 g/L titers were confirmed in a VHH nanobody at bioreactor scale.

Continuous in-line monitoring of glucose and lactate levels provides highly accurate, real-time data on cellular metabolism without the risks or data gaps associated with manual periodic sampling.

Take a look at how electrophoresis systems differ in sizing accuracy and why those distinctions matter for assessing high‑molecular‑weight DNA and protecting QC checkpoints across sequencing workflows.

Assessing AAV critical quality attributes (CQAs)—like aggregation and the full-to-empty capsid ratio—is vital for gene therapy safety and efficacy. Find out how SEC-MALS enables reliable analysis.

Explore an assay kit that simplifies handling with a methylcellulose-free medium and clear flow cytometric readout, which enhances automation and high-throughput sample acquisition for versatile research.

Review essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.

Data-driven virus clearance improves risk assessment, process insight, and study design. Uncover how Quality by Design cuts late-stage risk while strengthening regulatory confidence and viral safety.

Gain insight into how our dual LILRB2/LILRB4 antagonist monoclonal antibody offers a promising strategy to target MDSCs and enhance cancer immunotherapy.

High-throughput water endotoxin testing doesn’t have to sacrifice consistency. Delve into how an automated workflow delivers reliable results, low variability, and strong control recovery.

Efficiently collecting sufficient peripheral blood stem cells is paramount for successful transplantation, necessitating a deeper understanding of influencing factors and procedural nuances.

Real-time viable particle monitoring instruments have been available for over a decade. Read in detail about this technology and how it is used to detect viable particles in real time.

Heightened FDA scrutiny demands a shift from fragmented data to unified digital systems. Examine how to automate QA tasks, secure data integrity, and maintain a constant state of inspection readiness.

New USP 1132.1 guidelines standardize mass spectrometry for host cell protein analysis. These methods provide the specific protein identification and quantification needed to reduce clinical risk.

Discover how to adapt your environmental monitoring framework to meet the distinct risk-management and regulatory needs of ATMP facility production.