Ensure Sterility in cGMP Environment, Maximize Process Efficiency, Overcome Technical Challenges
GRAM offers cGMP capabilities and supports product development through commercialization. Our 3 m² (32 ft²) IMA Edwards Lyofast 3 freeze dryer with clean-in-place (CIP) capability provides cost-effective, reliable solutions and is available for both clinical and commercial-scale projects. We have the ability to lyophilize vials from 2 mL to 50 mL and up to 10,000 vials per batch.
GRAM 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, our team has 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 process development times while enabling more flexibility in process design, helping to lower capital costs.
Included in our SUS platform are a Pall wand mixer and a 200 L and 500 L Mobius jacketed system. GRAM can provide the specifications of all filling and receiving bags and vessels upon learning more about your project.
GRAM has qualified an aseptic formulation process to fit your suspension project needs.
Vial Filling: Liquid/Lyophilized
Our automated Bausch and Stroebel KSF1025 filling line can support clinical and commercial cGMP sterile liquid and lyophilized vial filling from small scale through high volume.
To provide optimal sterility in the manufacturing process, we have the capability of terminally sterilizing vials ranging from 2 mL to 50 mL.
Controlled Substances (Schedules III–V)
GRAM is DEA compliant with the special handling required for controlled substance licenses. We manufacture controlled drug substances Schedule III–V.
Labeling and Packaging
GRAM offers tertiary packaging services and custom kitting capabilities. Whether products are for clinical trials or the commercial market, GRAM identifies cost-effective and efficient integrated packaging and distribution solutions for you. For clinical studies, we provide custom packaging, labeling and study kit assembly, all guided by our expert project managers and quality and regulatory affairs teams.
Storage and Distribution
GRAM’s GMP operations support pharmaceutical packaging, returns, quarantine 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