INSIGHTS ON REGULATORY COMPLIANCE

• Implementing A Risk-Based Approach To Calibration

  Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

• A Simple Method For Cell Growth Media Preparation

  Explore how powder media and sterile fluid handling can reduce contamination risk and improve efficiency in viral vector production, especially for HEK293-based AAV workflows.

• 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.

• Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

  Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

• Identification Of GLP-1 Analog Oligomeric States Using SEC-MALS

  7/29/2025

  Discover how SEC-MALS enables precise characterization of GLP-1a therapeutics to ensure formulation integrity and enhance safety, efficacy, and regulatory confidence.

• Understanding cGMPs For Phase 1 Investigational Drugs

  8/15/2025

  Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.

• Your Guide To Precise And Robust Separation Methods

  11/12/2025

  Discover 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.

• Implementing Rapid Microbial Identification In Biotherapy Manufacutring

  5/27/2025

  Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.

• Qualicaps Virtual Pharma Expo September 2025: Oral Solid Dose Manufacturing And Packaging

  9/18/2025

  Explore how a new capsule inspection system helps manufacturers overcome labor shortages, increase throughput, and maintain quality while meeting global compliance standards.