01.23.26 -- Data Governance And Regulations For AI Use In GMP With Peter Baker

The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

Discover how to apply ICH Q2(R2) and Q14 to analytical procedures using QbD principles, ATP definition, and lifecycle management strategies to ensure regulatory alignment and product quality.

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

Observe how to determine the linear range for western blot quantification using total protein stains or housekeeping proteins to ensure accurate normalization and avoid saturation effects.

Explore the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.

Maintaining cGMP standards, controlling particulate contamination ensures drug safety, quality, effectiveness, and shelf life while preventing immune reactions and regulatory noncompliance.

While practical quantum computing applications remain far away, quantum biosensing applications with real-world impact in areas like immunotherapy and diagnostics are near at hand.

AI and MES can’t meet pharma’s visual inspection demands. Find out how purpose-built software ensures defect detection, compliance, and paperless quality for safer, more efficient operations.

Read about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

Choosing the right incubator requires more than reading specs. Learn how to evaluate performance metrics, contamination control, and real-world functionality to make confident equipment decisions.

Pre-use, post-sterilization integrity testing is vital for contamination control to ensure the integrity of sterilized equipment before use. Delve into how PUPSIT can enhance quality in your protocols.

Automated GPCR screening is now faster and more scalable with integrated cell-based assay solutions. See how combining high-throughput platforms with flexible assay kits can streamline workflows.

Review a detailed guide to characterizing GLP-1 receptor agonists that covers advanced LC-MS and SEC-MALS workflows for impurity profiling, stability testing, and aggregate analysis.

Alarm monitoring can be more than compliance. Explore how unified data and real-time insights helped one pharma company unlock efficiency, predictive analytics, and a path to digital transformation.

Accurate sizing and purity checks are essential in IVT RNA workflows. Discover how automated electrophoresis improves QC efficiency and ensures RNA integrity for downstream applications.

This presentation delves into the implications of the FDA Modernization Act 2.0, the significance of predictive validity in drug discovery, the efficacy of the Emulate human Liver-Chip, and more.

Conventional electroporation methods struggle with damaging heat buildup. Examine how innovative flow technology leverages physics to protect cells and enable large-scale therapeutic production.