Detailed chemical analyses during every step of production provide information about purity
There’s no room for error when manufacturing pharmaceuticals. Whether a therapeutic agent is destined for early-stage toxicity studies or Phase 3 clinical trials, making custom drug substances requires strict analysis and quality control in every step of production.
At Grace’s Fine Chemical Manufacturing Services (FCMS), integrated teams of chemists, engineers, operation managers, and regulatory experts specialize in supporting customers’ product development by providing active pharmaceutical ingredients (APIs) or drug substances, regulatory starting materials, and custom reaction intermediates to meet compliance standards. The teams achieve high levels of purity through consistent and precise chemical analysis during development and production.
Analysis at every step
Standard analytical capabilities at Grace’s FCMS include method development and optimization, chromatography, mass spectrometry, thermal testing, stability and validation capabilities, and assessment of physical properties. The R&D teams, plant operators, and analytical chemists work together to ensure that product specifications are met throughout every stage of manufacturing.
Collaborative teams that include process and analytical chemists, engineers, quality experts, and—importantly—customers, identify impurities early in process development. They work to understand how impurities form, how downstream processing affects impurities, and how to purge them. Together, the teams ensure that impurity-related challenges are solved before a process moves to production scale. This reduces the chances of an unplanned deviation during manufacturing. Experts at Grace’s FCMS have extensive experience in considering purging strategies for elemental impurities, as well as for potential or known mutagenic and genotoxic impurities.
Drug substances and APIs are considered acceptable for use within a time frame known as the retest period. Analytical teams at Grace’s FCMS conduct stability studies consistent with international guidelines when relevant, to assure that quality specifications and regulatory expectations are met throughout a product’s retest period. These studies confirm the resilience of the material before it is shipped. Thoughtful timing and planning of stability studies support the rapid development and commercialization of customers’ products.
Because analytical chemistry is critical in overall process development, Grace’s FCMS incorporates checkpoints into product development to establish successful processes and the production of quality materials. Highly experienced analytical chemists and process chemists work closely with customers to produce data necessary for regulatory applications.
The suite of analytical tools available to scientists and engineers at Grace’s FCMS supports standard analytical work such as method validation. These tools also enable the team’s experts to work with customers to solve a wide range of chemical challenges during fine chemical manufacturing.