Drug Substance
Scalable, compliant drug substance development from process design through cGMP manufacturing
End-to-End Development Expertise
Pharmaceutical developers face increasing pressure to advance drug candidates quickly while overcoming challenges related to process scalability, product quality, regulatory compliance, and supply chain reliability. MRIGlobal addresses these challenges through drug substance development expertise that includes process development, optimization, scale-up, analytical support, and cGMP manufacturing of active pharmaceutical ingredients and complex compounds. Utilizing these capabilities, our team may reduce development risk, accelerate timelines to clinical and commercial manufacturing, and enable reliable delivery of high-quality drug substances that support program success.
Comprehensive Drug Substance Lifecycle Support
Early-Stage Process Development
Design and optimize robust synthetic and manufacturing processes to support efficient development.
Process Scale-Up and Technology Transfer
Translate laboratory processes into scalable, reproducible manufacturing methods that maintain quality and performance.
cGMP Manufacturing of Drug Substances
Produce active pharmaceutical ingredients and complex compounds under cGMP conditions.
Analytical Method Development and Support
Develop and validate analytical methods, product quality, consistency, and regulatory compliance.
Clinical Supply Enablement
Support high-quality drug substance delivery to enable seamless transition to clinical trials.
