GRAM offers cGMP capabilities, with the ability to support early product development through commercialization, with a 3 m² (32 ft²) IMA Edwards Lyofast 3 Freeze Dryer with CIP capability. Our lyophilizer is available for both clinical and commercial scale projects. We have the ability to lyophilize vials from 2 mL to 50mL and up to 10,000 vials per batch.
Vial Filling – Liquid/Lyophilized
GRAM has aseptic vial-filling capabilities for liquid and lyophilized vials on both a clinical and commercial scale. Our automated Bausch and Stroebel KSF1025 filling line can support clinical and commercial cGMP liquid and lyophilized vial filling from small-scale through high-volume sterile vial filling.
We have the capability of terminally sterilizing vials from 2mL to 50mL vials.
DEA Controlled Substances (III-V)
GRAM is DEA compliant with Controlled Substance Licenses, approved to manufacture controlled drug substances Schedule III-V.
Labeling, Packaging and Kitting
GRAM is able to handle projects of varying scale, complexity and sensitivity to time and temperature. Compliance extends throughout operations and tertiary packaging design services. Custom kitting functions provide clients the ability to store bulk products yet deliver kitted solutions. GRAM performs all operations according to the client’s selected kitting protocol.
Whether products are intended for clinical trials or the commercial market, GRAM recognizes that having an integrated packaging and distribution solution is a cost-effective and efficient alternative for our clients. We provide custom packaging, labeling, study kit assembly all guided by our expert project managers, quality and regulatory affairs teams.
Storage and Distribution
GRAM maintains GMP storage for client material in these environments:
- Ambient Storage: +15°C to +30°C
- Refrigerated Storage: +2°C to +8°C
- Controlled Substance Storage, Schedule III – V
GRAM’s GMP supports pharmaceutical packaging, returns, quarantine, and controlled substances. GRAM’s secure warehousing and its implemented processes are utilized to mitigate risks that may adversely impact product safety, identity, strength, purity and quality.
- Validated Temperature Monitoring
- Validated GMP Warehouse Management System