Grand River Aseptic Manufacturing
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
Grand Rapids, Michigan, United States
Products
Aseptic Fill-Finish Services
Comprehensive aseptic fill-finish services for sterile injectable drug products, utilizing advanced isolator technology across multiple GMP manufacturing facilities.
GRAM Services
Comprehensive fill and finish services for parenteral drug products including biologics, small molecules, and controlled substances with capabilities from small scale to large scale filling, lyophilization, and testing.
Vial Filling
Sterile liquid and lyophilized vial filling services utilizing advanced isolator technology, automated systems, and expert aseptic manufacturing processes for biologics, small molecules, and vaccines.
PFS & Cartridge Filling
Expert team members support two sterile filling lines for syringes and cartridges, giving clients versatility to scale products.
Sterile Filling Facility One
Opened in 2020, Sterile Filling Facility One has production lines approved by both the EU and the FDA with the capacity to produce over 80 million vials and more than 10 million syringes and cartridges.
Sterile Filling Facility Two
Our second sterile filling facility provides over 50 million units of syringe and cartridge filling capacity, featuring the groninger UFVN high-speed syringe and cartridge filling line.
Aseptic Fill-Finish Services
Comprehensive aseptic fill-finish services for sterile injectable drug products, utilizing advanced isolator technology across multiple GMP manufacturing facilities.
GRAM Services
Comprehensive fill and finish services for parenteral drug products including biologics, small molecules, and controlled substances with capabilities from small scale to large scale filling, lyophilization, and testing.
Vial Filling
Sterile liquid and lyophilized vial filling services utilizing advanced isolator technology, automated systems, and expert aseptic manufacturing processes for biologics, small molecules, and vaccines.
PFS & Cartridge Filling
Expert team members support two sterile filling lines for syringes and cartridges, giving clients versatility to scale products.
Sterile Filling Facility One
Opened in 2020, Sterile Filling Facility One has production lines approved by both the EU and the FDA with the capacity to produce over 80 million vials and more than 10 million syringes and cartridges.
Sterile Filling Facility Two
Our second sterile filling facility provides over 50 million units of syringe and cartridge filling capacity, featuring the groninger UFVN high-speed syringe and cartridge filling line.
Services
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.
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.
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.
Freeze-drying campaigns with automated lyophilizer handling and validated sterilization and loading processes to support lyophilized product manufacturing at scale.
Finished product and material storage across controlled room temperature, refrigerated and frozen ranges with dedicated capacity and temperature-controlled transport 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.
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.
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.
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.
Freeze-drying campaigns with automated lyophilizer handling and validated sterilization and loading processes to support lyophilized product manufacturing at scale.
Finished product and material storage across controlled room temperature, refrigerated and frozen ranges with dedicated capacity and temperature-controlled transport 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
News & Updates
Grand River Aseptic Manufacturing appointed Bernie King as COO to support its rapid growth, facility expansion, and technological advancements.
The company completed a significant expansion including new sterile filling lines and finishing capacity to meet increasing demand.
GRAM signed a multi-year contract with the U.S. government, investing $160 million to expand its facilities and capacity for public health emergencies.
The company was recognized for its continuous improvement efforts and leadership in vaccine manufacturing during the COVID-19 pandemic.
Discusses the importance of standardization in large-volume subcutaneous drug delivery and how GRAM is involved.
An interview highlighting recent milestones, strategic direction, and innovations at GRAM.
Grand River Aseptic Manufacturing appointed Bernie King as COO to support its rapid growth, facility expansion, and technological advancements.
The company completed a significant expansion including new sterile filling lines and finishing capacity to meet increasing demand.
GRAM signed a multi-year contract with the U.S. government, investing $160 million to expand its facilities and capacity for public health emergencies.
The company was recognized for its continuous improvement efforts and leadership in vaccine manufacturing during the COVID-19 pandemic.
Discusses the importance of standardization in large-volume subcutaneous drug delivery and how GRAM is involved.
An interview highlighting recent milestones, strategic direction, and innovations at GRAM.