Hyaluron reconfigures cleanroom for formulation/fill operations


With the February announcement of a $1 million low-interest loan provided by MassDevelopment, Massachusetts’ finance and development authority, and Middlesex Savings Bank, pharmaceutical biotech contract manufacturer Hyaluron Contract Manufacturing, Inc. (HCM) is able to restructure the cleanroom and manufacturing space at its Burlington, MA-based headquarters as well as purchase backup systems for its electrical, HVAC, and mechanical infrastructure. HCM officials also expect to create 30 new high-tech manufacturing jobs in the year following the completion of the build-out in 2Q07.

Founded in 1999, HCM provides aseptic manufacturing services involving the formulation and filling of syringes, vials, and custom containers in a sterilized environment prior to their use in clinical and therapeutic applications.

Vial fill line and lyophilization unit in use at Hyaluon Contract Manufacturing. Photo courtesy of HCM.
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HCM’s decision to transform the cleanroom space was prompted by its desire to better accommodate its clients’ fill schedules while maintaining the integrity of aseptic processes. Shawn Kinney, HCM president, explains, “In light of increased demand for our existing services, as well as the addition of new services, such as lyophilization, we found it was necessary to reallocate existing cleanroom space in order to meet our clients’ needs and utilize valuable cleanroom space more efficiently.”

Although the size and footprint of the cleanroom area remains relatively unchanged, Kinney tells CleanRooms that the funds have allowed the company to reconfigure its existing space so more of it is dedicated to formulation/fill operations.

Specifically, space formerly assigned for storage and inspection packaging tasks, as well as a portion of a clean corridor, has been transformed into two Grade C formulation rooms equipped with HEPA BioGard hoods, a Grade A aseptic fill room, a Grade B aseptic fill support room, three airlocks, and a small storage room. Space also has been arranged for a viewing room outside the clean environment so clients can observe the formulation/fill process.

The addition of a BOC Edwards LyoMax3 Lyophilization Unit-which uses non-flammable, chemically inert SafeTherm HX transfer fluid-will enable HCM to offer aseptic lyophilization of vials “in an environment that is safer and more dependable; a service which, we feel, sets us apart from other contract manufacturers,” concludes Kinney.

Online vacuum fill/stopper syringe fill line suite. Photo courtesy of HCM.
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The recent loan combines a $500,000 direct investment by lead lender Middlesex Savings Bank, along with a $500,000 direct investment from MassDevelopment, supported by a $250,000 loan guaranty through MassDevelopment’s Export Loan Guaranty Fund.

In December 2005, HCM also was able to purchase lyophilization equipment with a MassDevelopment Emerging Technology Fund loan.

“Hyaluron’s impressive growth highlights the remarkable potential of the state’s emerging technology sector for job creation and investment in the economy,” notes Robert L. Culver, MassDevelopment president and CEO.

“It is our goal at Hyaluron to improve the safety and effectiveness of the products we work with to benefit our clients’ end user,” says Kinney. “Thanks to Middlesex Savings Bank and MassDevelopment for working with us to structure this dynamic financing package.”