Overview

PCAS-NANOSYN LLC was established in July 2009 as a 50/50 joint venture between PCAS, an established, major intermediate and API commercial manufacturer with multiple plant sites in Europe, and Nanosyn, a CRO offering a wide range of discovery medicinal chemistry and biology services with headquarters in Menlo, Park, CA and an additional site in Research Triangle Park, NC.

In order to tie together the offerings of PCAS and Nanosyn and provide a US based facility for initial scale-up and clinical trial materials, an existing cGMP kilolab scale facility with an excellent 30 year regulatory track record with the FDA and the State of California Department of Public Health was acquired in Santa Rosa, CA, just north of San Francisco in the middle of Sonoma County.

The Santa Rosa site offers custom organic synthesis, contract process R&D and cGMP manufacturing of milligram to multi-kilo lots of intermediates and active pharmaceutical ingredients to the pharmaceutical, medical device, diagnostic and semi-conductor industries as well as other industries where scale-up and small lot manufacturing services from a reliable vendor with excellent quality systems is important. Over the years, our joint venture partners have listened to clients and developed the following business practices and employee knowledge base:
  • Rapid CDA, proposal and contract turnaround
  • R&D and cGMP with a scale-up mentality
  • Ready access to decision makers
  • Professional, yet flexible business and quality systems
  • Non-competitive protection for customer IP
The PCAS-NANOSYN site has an established, comprehensive, and well-tested Quality and SOP system developed through many years of consultation with pharmaceutical clients and the FDA. The site has been regularly audited by the FDA and the California Department of Health Services, Food and Drug Branch. Many quality audits have been performed on site by our clients and we would be glad to schedule one from your company. The site is registered with the DEA for the handling of Schedule II, III, and IV controlled substances.

To insure that PCAS-NANOSYN will be a full-service supplier, the analytical methods development and analytical testing capabilities of the site have been upgraded such that most API release tests can be performed on site. In the few areas where the overhead for expensive equipment cannot be justified in providing cost benefits to our clients, testing is outsourced as appropriate to qualified and audited external laboratories. Additionally, the site can now offer stability data to clients.

PCAS-NANOSYN offers a seamless technology transfer link to larger volume scale-up services through full scale manufacture via PCAS plants in France and Finland. Listening, understanding and responding accurately to your business and technical needs . . . that’s the PCAS-NANOSYN advantage.

We invite you to review the adjoining Nanosyn and PCAS tabs and use the links to their websites to fully appreciate the strengths and capabilities of our managing partners and the broad range of services that this association can offer to help you successfully meet your most challenging drug discovery through commercialization needs.