INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Complex monoclonal antibody programs need specialized expertise, integrated capabilities, dependable capacity, and risk‑aware support to manage development, regulation, scale‑up, and global supply.

  • A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).

  • Explore an extensive analytical chemistry and microbial testing compliant portfolio for pharmaceutical analysis and quality control (QC) from early-stage drug development to product release.

  • The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

  • Understand how to confidently meet GxP compliance in the life sciences. Explore a framework encompassing people, processes, products, and services for regulatory adherence and data integrity.