Experienced Aseptic Manufacturing

Grand River Aseptic Manufacturing partners with pharmaceutical and biotech clients to fill and finish sterile injectable drug products that impact the lives of patients around the world

Grand River Aseptic Manufacturing (GRAM) is a sterile injectable contract development and manufacturing organization (CDMO) with deep pharmaceutical manufacturing experience in biologics, small molecules, and vaccines. GRAM’s partnerships with global pharma and biotech leaders give our team manufacturing experience with many aseptic drug products. Dedicated team members are supported by aseptic filling facilities encompassing top-of-the-line design elements with enhanced safety features and cutting-edge equipment. With 450,000 sq. ft. of sophisticated GMP production space, GRAM’s capacity accommodates customer and industry-wide demand for sterile injectable manufacturing of clinical and commercial projects.

Annex 1 Compliance

GRAM has five GMP manufacturing facilities, three of which are designed and qualified with Annex 1 revisions in mind. An outside compliance consultant performed a comprehensive Annex 1 requirements assessment. The GRAM team assessed gaps and established a contamination control strategy, which is updated and assessed regularly.

GRAM delivers quality aseptic fill-finish services with capabilities that include:

  • Biologics, small molecule, and vaccine manufacturing
  • Liquid vials, lyophilized vials, syringes and cartridges
    • Five filling lines with isolator technology allow our clients the ultimate versatility and flexibility to seamlessly scale their products as needed to succeed in the marketplace
  • Controlled substance manufacturing
  • Formulation volumes up to 1,000 L
  • Low and high-speed filling
  • Lyophilizer with auto-loader
  • Single-use-systems or product-dedicated process equipment
  • Terminal sterilization
  • Automated, semi-automated, and manual inspection
  • Labeling and packaging
  • Serialization and aggregation
  • Analytical testing
  • Regulatory support
  • Product storage, warehouse temperatures