Lyophilization Technology

Clinical Manufacturing

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.

Clinical Manufacturer
  • 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 products
  • Processing following Good Manufacturing Procedures as published in the Code of Federal Regulations, 21 CFR, Parts 210, 211, 600, and 820
  • US and EU Compliant
  • Lyophilizers ranging from 8 ft² to 48 ft² ( 0.7 m² to 4.4 m²)
  • Batch sizes up to 75 L (Aqueous / Organic Solvents)
  • ControLyo™, Nucleation On Demand
  • DEA Registration to handle Controlled Substances