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Pharma API Manufacturing and Synthesis Services

Pharmaceutical Sciences

High-quality active pharmaceutical ingredients (APIs) are core to the manufacturing of safe and effective drugs. MRIGlobal’s Pharmaceutical Sciences portfolio encompasses a broad range of flexible capabilities for pharma API manufacturing and other needs in the API market. Emerging pharmaceutical companies rely on us for the expertise we bring, the breadth of our capabilities, and our successful track record of regulatory excellence. MRIGlobal regularly works in compliance with current Good Manufacturing Practices (cGMP) to support manufacturing of early stage clinical investigatory materials. MRIGlobal views our group as a true partner because we work closely to develop strong relationships with government agencies, commercial businesses, and academic institutions. 

Our suite of chemistry pharmaceutical science services includes:

  • Research and development including route selection
  • Process improvements
  • Process development and optimization
  • Scale-up capabilities to support pre-clinical/tox-batch materials
  • Process Safety Assessment
  • Low-volume cGMP material preparation of API drug substance in kilogram quantities suitable for Phase I/II studies
  • Custom synthesis and characterization of high-purity reference standards, markers and impurities to support analytical method validation and assays
  • Services for custom isotope-labeled materials for bioanalytical applications to support toxicology studies

In addition to pharma API manufacturing, MRIGlobal also offers custom synthesis services in areas such as drug discovery, including the preparation of analog compounds for the purposes of testing (library scaffold synthesis) and focused libraries. MRIGlobal is always happy to discuss your needs and develop an appropriate approach to help you meet your goals. 

Typical API project process

MRIGlobal typically begins API projects with a process of thorough collaboration between our team and our partner. This includes discussing the project goals, deliverables, and customer expectations. Our strength is our Program Management and communication; the team, which at a minimum consists of a dedicated project manager along with a technical lead, creates a plan which is reviewed together with our client. The project starts with technology transfer, followed by process development and route optimization. Upon successful completion of those steps, we move to the production of a demonstration batch, which focuses on scale-up manufacturing of the API. 

The process optimization phase ensures maximization of key API deliverables; the purity and yield of material produced at each step. Analytical method development and phase-appropriate validation ensure the API, as well as key intermediates produced through the course of the synthesis, meet all required specifications concurrently with the chemistry portion. A full analysis is typically performed, which includes tests such as purity, identification confirmation, moisture content, residual solvent, elemental analysis, and crystalline form (and any other required tests for the final API). GMP API is released in compliance with 21 CFR 210/211 (CoA, COC, and BSE/TSE Statement). 

Additional support service capabilities

Our API support services include analytical chemistry, pre-formulation support, stability, storage, and quality assurance.

Our team has over 50 years of experience in performing analytical chemistry support and our facility is fully equipped to perform full characterization based on our customers needs. We have extensive experience in analytical method development, validation (preclinical through commercial), characterization/release testing and stability testing. To support our API team, our analytical techniques include, but are not limited to: 

  • spectroscopy (MS, AA, ICP, IR, UV, and NMR)
  • chromatography (TLC, GC, , HPLC, CE, HPLC/GPC, GC/MS, and LC/MS)
  • high resolution mass spectrometry
  • electrochemical and colorimetric titrations
  • a wide variety of physical measurements (DSC and TGA)

In the area of preformulation support, our team can help assess physicochemical properties, purity determination, and compatibility studies among others. 

Our commitment to quality is paramount and MRIGlobal has a long and successful track record of regulatory compliance. With an independent Quality Assurance group providing oversight, our group routinely performs work under US FDA current Good Manufacturing Practices (cGMP, 21 CFR 210/211), as well as following International Council for Harmonization (ICH) guidelines. 

We are FDA registered and inspected and are ISO 9001:2015 certified.

MRIGlobal’s pharma API manufacturing team has decades of experience

As a not-for-profit research institute, MRIGlobal serves industrial, academic, and government programs. Our API group focuses on process chemistry, multi-kilogram scale-up, synthetic chemistry, cGMP manufacturing, and pre-formulation development. The API team is supported by our independent quality assurance unit, repository operations, and analytical services group. As a group with decades of experience, our team has successfully developed innovative solutions to advance our client’s compounds through the development process. Whether the work involved initial scale up to support preclinical investigations, route optimization to facilitate further technology transfer, or cGMP manufacturing to support early clinical phase investigations, our team has a long and positive track record of meeting our clients needs. 

To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.