Ash Stevens adds high containment capacity and new low-temp pilot plant

October 1, 2007 — /PRWEB/ — DETROIT, MI — Ash Stevens(TM) Incorporated (ASI) recently brought two new Rosenmund filter-dryers and a 100-liter pilot plant with cryogenic capabilities online in its Riverview, MI development and manufacturing site — a total investment of more than $2.5 million. The large filter-dryer, a 0.3 m2 unit, is equipped with glove-box technology to facilitate handling of air-sensitive materials and to enable safe handling of Category 3 and 4 potent materials at plant scale. The smaller filter-dryer, a 0.03 m2 unit, was designed to be used with the new cryogenic pilot plant system. That new pilot plant has the ability to maintain temperatures as low as -80 degrees Celsius and has the flexibility to operate seamlessly to +200 degrees Celsius.

The new systems are modeled in ASI’s process laboratories with pocket filters and vessels using the same geometries as those found in the plant. These new capabilities facilitate the rapid scale-up of processes to support product requirements throughout clinical development and post-launch.

“It’s our mission to translate client discoveries into new products to help seriously ill people,” says Stephen Munk, president and CEO, ASI. “By upgrading our facilities with scaleable systems and assuring rapid product supply, we are investing in our customers’ success in the form of faster drug approvals. I am grateful for the continued support of our board and am really proud of the dedication, competence, and hard work of my colleagues at ASI.”

The company was recently approved to manufacture the active ingredients in Velcade(R), Vidaza(R), and Clolar(R). With these recent approvals, ASI now has a total of 11 FDA approved drug substances in its portfolio. These recent FDA manufacturing approvals represent 3 of the last 85 manufacturing approvals for new chemical entities as drugs.

About Ash Stevens, Inc.
Headquartered in Detroit, ASI was founded in 1962 to service the chemical research needs of the Federal Government. The company has since become a full-service, contract cGMP manufacturer of low-volume, high potency active pharmaceutical ingredients for life science companies and has expertise in process development and navigating the regulatory affairs landscape. ASI has a total of 11 FDA approved drug substances in its portfolio. The company has more than 50 employees and holds patents in both medicinal and process chemistry. The company maintains a state-of-the art, cGMP-compliant manufacturing plant in Riverview, MI, including reaction vessels with capacities up to 500 gallons.


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