Merck Therapeutic

Therapeutic Proteins Bulk Facility

Merck & Co., Elkton, VA

This project demonstrates:

• Quality - BPE Standards
• High Purity Piping Pre-Fabrication
• cGMP Installation
• eTOPS
• Project Controls & Scheduling

The Challenge

Merck & Co. recently completed construction of the new Therapeutic Proteins Bulk facility located at the Stonewall site in Elkton, Virginia. The Stonewall site is the only domestic Merck Manufacturing Division facility accommodating five major manufacturing technologies: fermentation, organic synthesis, sterile, pharmaceutical, and vaccine. The new facility houses a range of pharmaceutical manufacturing (batch processing) activities such as fermentation, solvent extraction, organic chemical synthesis and finishing operations. The facility's products include broad spectrum antibiotics, anti-parasitic drugs for human and animal health, a cholesterol lowering drug, a drug for the treatment of Parkinson's disease, a new drug for the treatment of human immunodeficiency virus (HIV) and the well-known vaccine GARDASIL, which is the only human papilloma virus (HPV) vaccine that helps protect against 4 types of HPV for girls and young women ages 9 to 26.

Intermech's Response

Intermech was selected for this critical fast track project as one of Jacobs' collaborative team members to assist with constructability issues and to begin fabrication and installation of over 12,500 lineal feet of process piping while the design was being finalized. Intermech completed the main process piping distribution systems feeding Merck's Fermentation skids, Harvest skids, Chromatography skids, Buffer Prep Tanks and the Microfiltration and Ultrafiltration skids, all of which are vital to the bulk manufacturing process from recombinant proteins and antibodies that will be used as various active pharmaceutical ingredients.

The Results

Intermech installed over sixteen complex hygienic systems consisting of Endotoxin Reduced Water, Clean Steam, CIP, Glycol, Process and others used in the manufacturing process of therapeutic proteins and experimental vaccines. This recent addition to Merck's new production facility for vaccines further enhances their biotechnical capabilities and makes the Stonewall site one of the company's primary vaccine production sites. Intermech's scope of work performed had a contract valuation of over $3.5 million and was executed from June of 2009 through July of 2010. The work was fabricated and managed from Intermech's McLeansville, NC Operations Center.