Parenteral Manufacturing, Aseptic Filling, Fill and Finish, Pharmaceutical Manufacturing Services, Aseptic Manufacturing Solutions
Reliable Pharmaceutical Manufacturing Solutions
Using cGMPs, we offer clinical and commercial-scale solutions for all your sterile manufacturing needs. Our quality processes, experienced staff, state-of-the-art equipment, advanced technology, and modern facilities provide exceptional results for your project.
Our team works with single-use systems (SUS) to streamline and facilitate the manufacturing of your project while mitigating the risk of cross-contamination. Trained and experienced with SUS, we have implemented a series of SUS best practices and can quickly determine which clients will most benefit from this technology. With SUS, we are often able to reduce pharmaceutical manufacturing and process development times, enabling more flexibility in process design to help lower capital costs.
Included in our SUS platform are a Pall wand mixer and a 100 L, 200 L, and 500 L Mobius jacketed system. We provide the specifications of all filling and receiving bags and vessels upon learning more about your project.
Grand River Aseptic Manufacturing has qualified an aseptic formulation process to fit your pharmaceutical manufacturing needs.
Liquid and Lyophilized Vials
Our automated Bausch+Ströbe filling lines can support clinical and commercial cGMP sterile liquid and lyophilized vial filling from small scale through commercial volumes. Learn more about our new facility and equipment.
Terminal Sterilization
To provide optimal sterility in the pharmaceutical manufacturing process, we have the capability of terminally sterilizing vials ranging from 2R to 50R.
Controlled Substances (Schedules III–V)
DEA compliant with the special handling required for controlled substance licenses. We manufacture controlled drug substances Schedule III–V.
Labeling and Packaging
Tertiary packaging services and custom kitting capabilities available. Whether products are for clinical trials or the commercial market, we identify efficient integrated packaging and distribution solutions for you.
Storage and Distribution
GMP operations support pharmaceutical packaging, returns, quarantined, and controlled substances. Our secure warehousing and processes mitigate risks to product safety, identity, strength, purity, and quality.
To avoid temperature excursions that can compromise product integrity, we offer validated temperature monitoring and GMP warehouse management for your materials in a variety of conditions, including:
- Ambient storage: +15°C to +30°C
- Refrigerated storage: +2°C to +8°C
- Frozen storage: -15°C to -25°C
- Ultra-low frozen storage: -70°C to -90°C
- Controlled substance storage, Schedule III–V