Active Pharmaceutical Ingredient Drug Substance
MRIGlobal accelerates pharmaceutical clients’ timelines from custom synthesis to GMP API drug substance preparation.
Whether you need library scaffold synthesis, toxicology batch material preparation, or material for an IND-enabling study, MRIGlobal has the staff, infrastructure, and Quality Assurance and Regulatory support to bring your project to the next milestone.
- Custom synthesis options and preparation of active pharmaceutical ingredient (API) in kilogram quantities suitable for Phase I studies. Our highly-experienced process chemists can find new ways to build your drug using cost-effective, commercially-available materials. We also can incorporate these steps into a scaled-up API manufacturing process.
- Custom synthesis and characterization of high-purity reference standards to support analytical method validation and assays.
- Services for custom isotope-labeled materials for bioanalytical applications to support toxicology studies.
The following describes a typical API project, but our projects are tailored to meet the client’s needs.
We begin with customer needs and expectations in mind. MRIGlobal proceeds with process development, delivers a demonstration batch, and focuses on scale-up manufacturing of the API preparation. We take steps to maximize the purity and yield of key intermediates produced at each step to deliver API for the customer’s needs. Parallel analytical method development and validation is performed to ensure that the API meets all required specifications such as purity, ID, moisture content, residual solvent, elemental analysis, and crystalline form.
MRIGlobal’s API development team has more than 50 years of combined experience.
We serve industrial, academic, and government programs focused on process chemistry, multi-kilogram scale-up, synthetic chemistry, cGMP manufacturing, and formulation development. API development is further supported by our independent quality assurance unit, cGMP repository operations, and analytical services group.