Grand River Aseptic Manufacturing

Overview

Grand River Aseptic Manufacturing (GRAM) is a contract development and manufacturing organization (CDMO) focused on sterile injectable fill-and-finish services. The company operates 450,000 sq. ft. of GMP production space across five manufacturing facilities, three of which are designed and qualified to Annex 1 revisions.

Core Capabilities

Fill-Finish Services:

• Liquid and lyophilized vial filling (four vial filling lines with isolator technology)
• Prefilled syringe (PFS) and cartridge filling (two dedicated sterile filling lines)
• Five filling lines total with isolator technology for redundancy and scalability
• Low and high-speed filling options
• Terminal sterilization

Manufacturing Experience:

• Biologics, small molecules, and vaccines
• Controlled substance manufacturing
• Formulation volumes up to 1,000 L

Ancillary Services:

• Lyophilization with auto-loader
• Single-use systems or product-dedicated process equipment
• Automated, semi-automated, and manual inspection
• Labeling and packaging
• Serialization and aggregation
• Analytical testing
• Regulatory support
• Product storage at warehouse temperatures

Regulatory & Compliance

GRAM maintains Annex 1 compliance across three of its five GMP facilities. The company has conducted comprehensive Annex 1 requirements assessments with outside compliance consultants and maintains an updated contamination control strategy.

Strategic Focus

The company emphasizes strategic partnerships with innovators in drug delivery devices, offering tailored solutions for autoinjectors and on-body delivery systems to accelerate time-to-market for innovative therapies.