Clinical Manufacturing Capabilities
Capabilities for preparation, processing, as well as finished product testing are available for biologicals, oncology products, and highly potent compounds. Preparation of clinical materials in this expanded facility complement the extensive activities currently performed in the conventional development laboratory and pilot plant. Batch preparation, aseptic processing and lyophilization are completed in a unique environment that provides safety and security for product and personnel. This is achieved by a high level of control throughout the operation, supported by the facility layout, processing equipment used in batch preparation, as well as environmental controls.
• Pre-clinical to Phase II Clinical Materials, lyophilized and liquid products
• Dedicated / disposable product contact items/equipment for the highest level of quality and
purity for each product
• Containment capabilities for handling cytotoxic/high potent APIs including biologics and oncology
• Processing following Good Manufacturing Procedures as published in the Code of Federal
Regulations, 21 CFR, Parts 210 and 211
• US and EU Compliant
• Automated filling and stoppering of 2 through 10 cc vials fitted with 13 mm stoppers, 5 to 160 cc
vials having 20 to 28 mm stoppers, and cartridges/syringes
• Lyophilizers ranging from 8 sq. ft. to 48 sq. ft.
• Batch sizes up to 75 L (Aqueous / Organic Solvents)
• ControLyo™, Nucleation On Demand
• DEA Registration to handle Controlled Substances