MCP To Produce Supplies of Biologic Drug Product For Late-Phase Clinical Trials

MCP Pharmaceuticals To Produce Supplies of Biologic Drug Product For Late-Phase Clinical Trials

PARSIPPANY, NJ April 17, 2013 — MCP Pharmaceuticals, a leading provider of global contract manufacturing services for sterile products has entered into an agreement with an undisclosed biotechnology company to produce clinical supplies of a biologic for late-phase clinical trials. MCP’s cGMP compliance history was a critical factor in the selection process. Stuart Hinchen, CEO stated, “Our record of cGMP compliance, driven by experienced Quality and Regulatory Teams continues to be one of the key reasons customers choose MCP. Additionally, both new and established customers recognize our approach to ongoing investment in people and facilities.

As an example, last year we broke ground on a new $10 million, 40,000 sq. ft. laboratory that will house QC Chemistry and Method Transfer, Sterility Assurance and Stability. This type of investment allows us to focus on customer needs, which results in sustainable sales growth.” Hinchen noted, “Our use of disposable product contact equipment is another leading factor in the selection process. MCP’s strategic use of disposables provides our customers with manufacturing process efficiencies that result in reduced cycle time.” MCP Pharmaceuticals’ Rochester, Michigan facility has over 25 years’ experience in contract manufacturing.

Expertise in seamlessly progressing from clinical batch production to commercialization provides customers with continuity of supply and program efficiencies. A comprehensive suite of services including Regulatory, Analytical Methods Development, Package Engineering, Stability Testing and Validation also support contract manufacturing customers. MCP has successfully supported launches of several products in US and international markets and manufactures products for sale in 86 countries.

About MCP Pharmaceuticals, LLC

MCP Pharmaceuticals, headquartered in New Jersey, provides contract manufacturing of sterile products including biologics, small molecule, controlled substances, vaccines, ophthalmics, otics and antibiotics for large and small pharmaceutical and biotech organizations. MCP’s sterile manufacturing facility, located in Rochester Michigan sits on over 80 acres of land and includes a 171,000 sq. ft. production building and warehouse.

The production facility utilizes three high-speed filling lines, a clinical filling line and four lyophilizers. The site also includes separate facilities for chemistry, sterility testing, and analytical methods development. MCP has the capability to manufacture small-scale clinical through large-scale commercial products. MCP employs more than 380 staff in the USA in its manufacturing, product development, regulatory, sales and marketing and corporate areas. For more information, please visit jhppharma.com.

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