cGMP Manufacturing

Serving the Biotech and Pharmaceutical Community for 20+ years

Nanosyn is committed to assisting pharmaceutical and biotech companies in identifying or transforming drug discovery candidate synthetic processes into improved, scaled-up processes and providing drug substance for pre-clinical trials, clinical trials, and small lot commercial manufacture.

Chemical synthesis of components for medical device companies is also an area of strong expertise.

World-Class cGMP Facilities

Our facility in Santa Rosa, California has successfully provided APIs as well as process identification and scale-up services to the biotech and pharmaceutical community since the late 1970’s. The site successfully passed FDA inspection in July 2018 with no 483.

A unique feature of the site is that it allows for flexible, personal and cost effective services, and has cGMP capability designed for clinical trials and small scale commercial APIs

Capabilities and Technical Expertise

Six independent HEPA-filtered cGMP production suites
Reactor sizes range from 5L to 100L
Core team has worked on multiple projects starting from process development all the way through Phase I, Phase II, Phase III and commercial.

cGMP production is headed by a production manager who has 25 years of experience in process research and development, scale-up and manufacture. On average each process chemist and production chemist has 15 years of experience conducting process research and develop mentor API manufacture.

cGMP Manufacturing

Serving the Biotech and Pharmaceutical Community for 20+ years

World-Class cGMP Facilities

Capabilities and Technical Expertise

Ready for help with cGMP Manufacturing?