Gateway 2011: Grand River Aseptic Manufacturing

• General Company Company Description:

Grand River Aseptic Manufacturing is a parenteral contract manufacturer supporting new product development and small batch production. With a state‐of‐the‐art cleanroom and highly trained staff, Grand River Aseptic Manufacturing provides small scale clinical trial materials aseptically filled into vials and lyophilization for the pharmaceutical and biopharmaceutical markets.

Grand River specializes in pre‐clinical, phase I through III clinical trials, and small scale commercial production quantities. We offer the following services for clinical, small scale, and commercial‐stage products: Sterile product development and manufacture, Lyophilization, Terminal sterilization and Analytical and microbiological services.

• Technical Services:

• 
  
• Sterile product development and manufacture

• Lyophilization of vials 2 to 50 mL

• Terminal sterilization

• Analytical and microbiological services

• Aseptic filling of vials 2 to 50 mL

• Formulation development

• Test method development and validation

• Process development and validation

• Controlled temperature storage

• On-site warehouse and material storage

• Regulatory support
  

• Facilities:

Our Grand Rapids, Michigan facility includes:

• 11,400-ft² cGMP FDA registered facility

• Class 100 aseptic filling suite

• Class 10,000 processing area

• Formulation Suite

• Preparation Lab

• Steam Sterilizer

• USP Compliant WFI System

• IMA Edwards Lyophilizer with CIP capabilities (31 ft²)

• Capmatic Bambino Filler and Capper

• PennTech - RW-500 Vial Washer

• Lytzen Depyrogenation Oven

• Major Products/Services:

Grand River specializes in pre‐clinical, phase I through III clinical trials, and small scale commercial production quantities. We offer the following services for clinical, small scale, and commercial‐stage products: Sterile product development and manufacture, Lyophilization, Terminal sterilization and Analytical and microbiological services.

• Markets Served:

Grand River Aseptic Manufacturing serves the global pharmaceutical and biopharmaceutical industries.

Grand River Profile Sheet

Innovation Michigan Finalist: Grand River Aseptic Manufacturing

Grand River Aseptic Gains FDA Registration

Visit us at: Booth 1342
If you would like to schedule a personal meeting during the 2011 AAPS show please call or email: Greg Gonzales at (240) 344-9412 / ggonzales@grandriverasepticmfg.com.