Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing (GRAM) is a leading pharmaceutical contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish services for biologics, small molecules, and vaccines. The company supports pharmaceutical development, cGMP manufacturing, analytical testing, regulatory filing, and advanced drug delivery systems. With a focus on quality, innovation, and customer service, GRAM has expanded its facilities and capabilities to meet the growing demand for sterile injectable products, including large-scale fill/finish, lyophilization, pre-filled syringe manufacturing, and advanced inspection and packaging solutions. GRAM emphasizes Annex 1 compliance, technological innovation, and strategic partnerships to deliver safe, effective, and patient-centric pharmaceutical solutions.
Industries
Nr. of Employees
medium (51-250)
Grand River Aseptic Manufacturing, Inc.
Grand Rapids, Michigan, United States, North America
Products
Sterile Fill-Finish Services
Provides aseptic fill-finish services for liquid vials, lyophilized vials, syringes, and cartridges for clinical through commercial products.
Advanced Aseptic Manufacturing Equipment
Utilizes advanced filling lines with identical filling and isolator technology for scalable pharmaceutical manufacturing.
Analytical Testing Services
Offers analytical testing for biologics, small molecules, and vaccines, including microbial and analytical testing for various stages of drug development.
Regulatory Filing Support
Supports pharmaceutical development with regulatory filing assistance for biologics, small molecules, and vaccines.
Flexible Filling Technology
Features flexible filling technology for seamless scaling of pharmaceutical products, including the Bausch+Ströbel VarioSys modular system.
Sophisticated Inspection, Finishing, and Warehouse Center
Includes advanced inspection, packaging, testing, and warehouse capabilities, with automated and manual inspection systems.
Sterile Fill-Finish Services
Provides aseptic fill-finish services for liquid vials, lyophilized vials, syringes, and cartridges for clinical through commercial products.
Advanced Aseptic Manufacturing Equipment
Utilizes advanced filling lines with identical filling and isolator technology for scalable pharmaceutical manufacturing.
Analytical Testing Services
Offers analytical testing for biologics, small molecules, and vaccines, including microbial and analytical testing for various stages of drug development.
Regulatory Filing Support
Supports pharmaceutical development with regulatory filing assistance for biologics, small molecules, and vaccines.
Flexible Filling Technology
Features flexible filling technology for seamless scaling of pharmaceutical products, including the Bausch+Ströbel VarioSys modular system.
Sophisticated Inspection, Finishing, and Warehouse Center
Includes advanced inspection, packaging, testing, and warehouse capabilities, with automated and manual inspection systems.
Services
Aseptic fill–finish services for parenteral formats
Clinical through commercial sterile filling and finishing for liquid and lyophilized parenteral formats using isolator containment, platform-standardized filling lines, and supporting technical transfer to commercial scale; includes capability for rapid commissioning to support time-sensitive programs.
Inspection, finishing, labeling and packaging
Automated and manual inspection, multi-line labeling and packaging, check weighing, tamper-evident packaging and aggregation with serialization integration, operating in temperature-capable finishing workflows.
Analytical QC and microbiology testing services
QC testing services including sterility testing in isolators, wet chemistry for raw materials, chromatography (LC/GC), headspace gas analysis and stability support to enable release and stability programs.
Lyophilization services
Freeze-drying campaigns with automated lyophilizer handling and validated sterilization and loading processes to support lyophilized product manufacturing at scale.
Cold-chain storage and temperature-controlled logistics
Finished product and material storage across controlled room temperature, refrigerated and frozen ranges with dedicated capacity and temperature-controlled transport support.
Regulatory, QMS and project lifecycle support
Regulatory filing support, project management across technical transfer, qualification and commercial launch phases, contamination control planning aligned to current sterile processing guidance, and laboratory QMS/electronic records implementation support.
Aseptic fill–finish services for parenteral formats
Clinical through commercial sterile filling and finishing for liquid and lyophilized parenteral formats using isolator containment, platform-standardized filling lines, and supporting technical transfer to commercial scale; includes capability for rapid commissioning to support time-sensitive programs.
Inspection, finishing, labeling and packaging
Automated and manual inspection, multi-line labeling and packaging, check weighing, tamper-evident packaging and aggregation with serialization integration, operating in temperature-capable finishing workflows.
Analytical QC and microbiology testing services
QC testing services including sterility testing in isolators, wet chemistry for raw materials, chromatography (LC/GC), headspace gas analysis and stability support to enable release and stability programs.
Lyophilization services
Freeze-drying campaigns with automated lyophilizer handling and validated sterilization and loading processes to support lyophilized product manufacturing at scale.
Cold-chain storage and temperature-controlled logistics
Finished product and material storage across controlled room temperature, refrigerated and frozen ranges with dedicated capacity and temperature-controlled transport support.
Regulatory, QMS and project lifecycle support
Regulatory filing support, project management across technical transfer, qualification and commercial launch phases, contamination control planning aligned to current sterile processing guidance, and laboratory QMS/electronic records implementation support.
Expertise Areas
- Aseptic fill–finish manufacturing for vials, syringes and cartridges
- Lyophilization and freeze-drying process development
- Quality control, sterility testing and analytical support
- Annex 1 contamination control and isolator decontamination strategies
Key Technologies
- Isolator containment systems for sterile processing
- Automated visual inspection and machine-vision algorithms
- Lyophilizers with automated loading/unloading
- Headspace gas analysis for oxygen measurement