Process Chemistry
PharmAgra Labs has developed efficient manufacturing processes from a number of laboratory-scale syntheses (obtained from literature, client and/or PharmAgra research). Our management has experience with cGMP manufacturing in equipment up to 2,000 gallons. This knowledge and experience enables us to develop efficient, real-world solutions to our clients' production needs.
Recent projects include a successful multiyear collaboration with a small biotech company requiring the development of a commercial API manufacturing process starting from a 12-step medicinal chemistry route. We designed a new manufacturing process that we used to produce multi-kilogram lots of product. This process was later transferred to a large scale cGMP manufacturer. Production of key intermediates was transferred to both domestic and offshore suppliers.
Other projects include the development of commercial multi-kilo processes for several generic drugs that have been transferred to large-scale manufacturers. We have also developed an efficient kilo-scale photochemical manufacturing process for a pharmaceutical intermediate.
Process chemistry services include:
- Process development
- Route scouting and selection
- Optimization
- Scale-up
- Process documentation
- Tech transfer services, domestic/offshore
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