SBIR and STTR Success Story for
Physical Sciences Inc.

(Information Posted/Updated on 05/10/2012)

Physical Sciences Inc.
20 New England Business Center
Andover, MA  01810

Contact:    Dr. Mark A. Druy
Phone:      978-738-8195
E-mail:      druy@psicorp.com
Web Site:  http://www.psicorp.com

Project Title:  Process Endpoint Monitor for Lyophilized Biologics for Cancer Treatment
Related Award(s):  HHSN261200900023C
Technology Developed:
Physical Sciences Inc. developed a tunable diode laser absorption spectroscopy (TDLAS) based water vapor mass flow rate sensor (LyoFlux®) that continuously monitors the removal of water during lyophilization (freeze drying) of pharmaceutical products. The LyoFlux® monitor measures the water vapor concentration and gas flow velocity in the spool connecting the lyophilizer chamber and condenser enabling the non-intrusive determination of the sublimation rate throughout the primary and secondary drying phases of lyophilization.

Key Words:  Lyophilization, Freeze-Drying, TDLAS, Mass Flow Rate, Primary Drying Endpoint, Secondary Drying Endpoint.
Uses of Technology/Products/Service:
LyoFlux® is an optically-based water vapor mass flow rate monitor that enables pharmaceutical process development scientists and manufacturing engineers to continuously monitor the removal of water from freeze-dried pharmaceutical products throughout the lyophilization process. Pharmaceutical industry process development scientists have demonstrated the application of LyoFlux® as an important tool in their Quality by Design (QbD) approach to the development of freeze drying processes. This innovative technology supports the FDA and industry initiatives for the application of Process Analytical Technology (PAT) tools for the advancement of pharmaceutical manufacturing. This technology may also be applied to monitoring additional pharmaceutical manufacturing processes including fluid bed drying, vacuum drying and spray coating operations. The technology may also be applied beyond the pharmaceutical industry to monitoring operations during fine chemical production.

Benefit to Company:
The NIH support for the development of the LyoFlux® sensor has enabled Physical Sciences Inc. scientists and engineers to foster a close working relationship with experts within the School of Pharmacy, specifically the lyophilization community at the University of Connecticut. These relationships have led to new product ideas and the sale of LyoFlux® monitors. PSI has also developed strong working relationships with lyophilizer equipment suppliers which now offer lyophilizers equipped with spool pieces that accept the LyoFlux® optical interface. LyoFlux® has been installed on laboratory, pilot and production scale lyophilizers resulting in >$1M in instrument sales. PSI anticipates that instrument sales will continue to increase as more pharmaceutical companies adopt the technology in response to the FDA QbD initiative.

How Product Was Commercialized:
Commercialization efforts initially focused on leveraging relationships with lyophilizer equipment manufacturers and the identification of early adopters within the pharmaceutical industry. In addition, PSI maintained a close relationship with UConn researchers focused on novel application of the technology. These activities led to technical publications and oral presentations at international meetings and additional interest in the new technology. PSI supported the commercialization effort through investments in the hardware development and manufacturability of the product. Current and future commercialization efforts are focused on the development of sales, marketing and services relationships with lyophilization consultant companies.

Past R&D and/or Sales from this Project:   $1.5 M
Estimated Future Annual R&D and/or Sales from this Project:   $1 M