Pharmaceutical Process Development
Southwest Research Institute (SwRI) is a nonprofit contract research organization (CRO) offering comprehensive pharmaceutical process development services for drug substances, which include technology transfer, lab-scale process evaluation, process development and optimization, parametric studies, design of experiments (DoE) and pilot-scale engineering runs. Analytical services include method transfer, method development and validation, specifications development, reference standard qualification and CGMP support.
Translating Medicinal Chemistry into Manufacturing Routes
Reaction carousel system enables rapid catalyst & reaction condition screening.
LC-MS mass counts reaction results for a Suzuki-Miyaura carbon-carbon cross coupling reaction with various catalysts.
Classical catalyst screening for anhydrous organometallic reactions.
SwRI provides end‑to‑end, small‑scale, benchtop chemistry to identify and optimize drug candidates in the exploratory R&D space. We then transfer lead candidates to pilot-scale to support IND‑enabling studies and future commercial success. Our chemists design robust synthetic routes to secure the prototype material supply needed for first‑in‑human therapeutics.
- Gram to kilogram scale-up and engineering runs
- Technology transfer and evaluation of existing process
- Cost, safety and scalability evaluation
- Process optimization and parametric studies (design space)
- De novo process development and evaluation
- Specialized needs (chromatography, flow chemistry, calorimetry)
- Analytical method development support
Learn more about our Process Development Services capabilities or contact Shawn Blumberg, Ph.D. for more information.
Catalyst Screening & Catalyst Research Services
In combination with high-throughput screening and applying machine learning, a broad range of chemical transformations can be run metal-catalyzed, aiming for shorter chemical routes and greener processes. In the last two decades, carbon- and carbon–heteroatom cross-coupling reactions — such as Suzuki-, Buchwald-Hartwig-, Negishi-couplings and others — emerged as two of the most important transformations for process chemists, also having a significant impact on the design of drug substance synthesis.
- Homogenous catalyst systems
- Heterogenous catalyst systems
- Catalyst recycling
- Solubility screening
- Physicochemical properties and salt screening
Pilot Plant Design & Operation Services
Solubility screening and salt selection.
Ensure the proper systems are in place and allow us to design your pharmaceutical process plant. Design, test and build out chemical process methods before investing in large-scale manufacturing facilities.
- Analysis and isolation of process impurities
- Sustainability analysis to maximize process yields
- Prioritize health exposure limits and drug safety specifications
Synthetic Automation & Digitalization
50-liter roto evaporatory instrument.
Improving molecular properties and reaction outcomes is a priority for developing cutting-edge science. SwRI invests in automated workflows and operational efficiencies to deliver solutions that improve the quality of our deliverables and reporting. Our automated synthesis platform (ACP) achieves high experimental reproducibility, ensuring that our closed-loop feedback for machine learning applications can extrapolate synthetic insights from reaction libraries.
- Experimental planning and route scouting
- 24-hour automated synthesis platform
- In-house, on-device small-language model (SLM) models for sensitive data
- Enterprise scale large-language model (LLM) models for public data
Learn more about our Automated Synthesis Platform capabilities or contact Travis Mernard, Ph.D. for more information.
Chemical Purification & Chromatography Services
Calcium-assisted ion chromatography for the purification of highly polar small molecules.
SwRI’s improved normal-phase chromatography is achieved with ion-assisted methodology developed for highly polar organic compounds like amines, amine salts and peptides — key ingredients in active pharmaceutical ingredients (APIs). By incorporating calcium-based salts in normal-phase chromatography, SwRI achieves cost-effective and reliable purification, meeting U.S. FDA purity standards. This ion-assisted method, developed through years of internal research, has the potential to purify complex mixtures of peptide oligomers, alkaloids, macrocycles and small molecules.
- Ion pair chromatography additives
- Chromatography purification
- Flash column chromatography
- Aqueous & organic extraction
Chemical Process Development (CGMP Manufacturing)
200-liter reactor for synthesizing kilogram batches of active pharmaceutical ingredients.
Process chemistry services range from technology transfer and lab-scale process evaluation through de novo process development, safety and scalability analysis, process optimization, purification development, salt screening and engineering runs. Our experienced team can develop processes to overcome common process hurdles including safety, scalability and specialized purifications.
Learn more about our Chemical Process Development and CGMP Manufacturing capabilities or contact Tristan Adamson, Ph.D. for more information.
