Xcellerex and Superior Collaborate on Paperless Manufacturing

November, 2003

Xcellerex LLC in Marlborough, MA, a fast-growing contract manufacturer of Biologics, is improving the way business is done in contract manufacturing. In collaboration with Superior Controls, Xcellerex is designing automation and information systems for its manufacturing processes and business that will make critical information available to its customers through web interfaces. Superior Controls is providing consulting and technical resources to develop this paperless EFactory initiative.

Typically, a pharmaceutical or biotech company (the customer) that develops a potential drug therapy must test the drug in clinical trials as part of an FDA-required approval process. The customer often outsources the manufacture of this clinical drug supply to a contract manufacturing organization (CMO). The CMO implements the various process steps, such as media prep, buffer prep, seeding, cell culture production, harvesting, purification, and chromatography in strict accordance with the customer's instructions. But until now, there has been no easy way for customers to continuously monitor the process online to make sure that the CMO is following their detailed batch procedures and meeting their production requirements.

This communication gap with the CMOs has motivated several experienced manufacturing scientists and engineers at Xcellerex to redesign the entire customer interface.

Xcellerex's proprietary manufacturing platform, called Flexmax, is designed to rapidly produce biotherapeutics products for the clinical trial market. The process can also be used for biogenerics, personalized medicines, and vaccines. By using a unique combination of single-use manufacturing equipment and modular systems, Xcellerex is able to eliminate CIP, SIP, autoclaves, washers, and the other support equipment found in traditional, capital intensive pharmaceutical facilities. Xcellerex has used these innovative manufacturing technologies to manufacture GMP products.

Phase I automation of the Xcellerex FlexMax platform, used a PLC-based automation system to collect temperature, flows, and other critical process data from the seeding, production, harvesting, concentration, and chromatography steps and saved these electronic records to a SCADA system.

Phase II automation will make these electronic batch records available to customers through a web interface. Additionally, all documentation normally provided on paper will become an electronic record. All critical manufacturing and business records, such as standard operating procedures, operator training status, validation, metrology reports, and work instructions will be placed on glass (the monitors), so they are transparent and easily available to the customers via a wide area network, in real time.

Parrish Galliher, President/CEO for Xcellerex, says, "We're collaborating with Superior Controls because of their focus and broad experience with automation projects for the BioPharm Industry. Their staff of 30+ engineers and ability to implement large automation projects with validation and GAMP4 documentation is a critical factor."

Xcellerex, although not yet a household name, is poised to revolutionize the way contract manufacturers service the BioPharm Industry.