Purisys is a proven leader in custom API synthesis and manufacturing. We bring more than 40 years of experience in commercial pharmaceutical production –everything you need to scale up quickly and smoothly, without delays.
Our extensive experience can help you reach your goals. We have experience working with emerging biotech companies looking for a skilled outsourcing partner to take your compounds to trial and with large pharma companies that want to outsource parts of their supply chain to increase efficiency and speed to market.
When you work with Purisys, you collaborate with a team that understands the specialized environment of the drug development process. We provide a CDMO offering that links route selection, process development services, analytical support, and manufacturing into one integrated process. We offer the people, the processes and the critical infrastructure to rapidly advance your projects.
Responsiveness is critical to our offering. We understand the tremendous timeline and financial constraints under which you operate. Our personnel bring decades of experience in the multiple disciplines required for rapid, successful drug development, having worked on bringing drugs to market themselves.
|Process R&D||Global Sourcing||CI-CV Controled Substances|
|Analytical R&D||Sterile Processing||5 US DEA Licenses|
|Small Molecules to Large Molecules||High Potency Manufacturing||Global Logistics|
|Scale-up and Modeling||Automation and PAT||Preclinical to Commercial Filing Support|
|QbD Principals||Broad Milling Technologies||Global Regulatory Experience|
Our flagship, 17,000-square-foot innovation center and manufacturing facility in Athens, GA, provides complex, high-barrier custom synthetic chemistry and manufacture of pharmaceutical APIs, as well as comprehensive controlled substance expertise featuring Drug Enforcement Administration (DEA)-secure manufacturing.
Development activities at Athens include process development and optimization, analytical method development, optimization and validation along with product design and development, formulation development and testing.
The facility also offers reference standard synthesis and qualification, small-scale Current Good Manufacturing Process (cGMP) clinical and commercial manufacturing, non-sterile, parenteral processing and milling, and custom packing. Purisys offers a fully operational global supply chain and exports to more than 40 countries – with full international regulatory compliance.
Via our parent company and external partners, our supply chain network has manufacturing capacity for clients in need of more than 180-360 MT of Active Pharmaceutical Ingredients (APIs). In addition, we hold our own commercial drug master files (DMFs) for several specialized compounds, and we maintain a 300+ compound commercial reference standard library, including APIs, synthetic impurities, degradation products, metabolites and more.
At Purisys, we offer proven technical and regulatory expertise to scientists and drug developers seeking to develop custom APIs for clinical and niche commercial purposes.