INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).

  • Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.

  • Experience reliable, user-friendly buffer exchange and sample concentration with a system enhanced with precise pressure control, improved stirring, and durable components for effortless lab-scale filtration.

  • A transformative cell line development workflow with automated clone screening and optional monoclonality assurance on day 0*

    The ClonePix® 2 Mammalian Colony Picker​ is a complete solution for the automated screening and objective selection of high-value clones across diverse cell types.

    The ClonePix® 2 Mammalian Colony Picker is a fully automated system for selecting high-value clones used in antibody discovery and cell line development. Screen more clones in less time with monoclonal verification on day zero, then screen and identify for highest producers in weeks, not months.

  • As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.