Facility
The site of PCAS-NANOSYN in Santa Rosa, CA has successfully provided the custom synthesis of intermediates and active pharmaceutical ingredients (API), as well as process identification and scale-up services, to the pharmaceutical and biotech community from the San Francisco Bay Area since the late 1970’s and has been registered with the FDA and State of California as a drug manufacturing establishment for over 30 years. The site holds a DEA registration for Schedule II, III, and IV controlled substances.The on-site facilities are set up to support helping our clients make the transition from milligram quantities of discovery intermediates and API’s into scale-up R&D quantities for toxicity testing and formulation work and cGMP manufacture for clinical trials and small lot commercial API manufacture, including analytical methods development with in-process and final product testing.
cGMP Facilities
Dedicated facilities for manufacture under cGMP protocols completed in 2000 include six, independent, HEPA-filtered cGMP suites, each with a walk-in hood capable of housing vessels up to at least 100 liters and auxiliary equipment, some with the capability of expansion to fit larger size vessels. In 2006, two of these cGMP suites were upgraded and certified as Class 10,000 clean rooms. The cGMP area includes segregated areas for quarantined raw materials, released raw materials, finished product storage, and dedicated cGMP glassware and equipment.
R&D Facilities
The R&D lab was completely renovated in 2009-2010. The new state-of-the-art lab is now equipped with 5 bench hoods and 3 walk-in hoods for scale-up to 100 L.
Analytical Support Facilities
A separate analytical and quality control laboratory supports both R&D and cGMP operations.
The Quality Control lab was also upgraded in 2009-2010 (along with the R&D lab). Several more HPLCs have been added, along with LC-MS, FT-IR, head space GC adapter (for residual solvents), Karl Fischer (for moisture content), DSC (for thermal analysis), and other instrumentation. The site is now set up to do API release for most of the usual final product release tests.
PCAS-NANOSYN will also benefit from the extensive range of analytical capabilities and services offered by Nanosyn and PCAS, especially those nearby at Nanosyn headquarters, which include multiple LC-MS with fraction collection capabilities, NMR, and Rigaku X-Ray crystallography for small molecules (single crystal).
Potential for Expansion
The cGMP and R&D facilities account for two-third’s of the space at the site, with one-third available for future expansion, which could include dedicated facilities to support client commercial products. Customers who may be interested is such expansion to be dedicated for their use are invited to contact PCAS-NANOSYN for further discussions and evaluation.
