Lyophilization Technology

Development Sciences

Development Sciences Capabilities

Our Development Sciences laboratories provide a flexible environment that accommodates a multitude of processing activities, from compounding bulk solutions ranging from a few milliliters to forty liters, to finished product characterization. Critical areas for component preparation, solution filtration, along with filling, stoppering and lyophilizer loading and unloading operations are all within a certified Class 100 (ISO 5) HEPA air supply environment to emulate aseptic operations for typical for processing sterile products. Contact us to learn why this is vital to your product, even in the development stage.

From Preparation to Finished Product

Preparation, processing and finished product evaluation are completed by qualified scientists and technicians following predefined methods and procedures. The study preparation is conducted to adhere to general principles and applicable guidelines of current Good Manufacturing Practice as published in the Code of Federal Regulations, 21 CFR, Parts 210, 211, 600, and 820.

Qualified Equipment & Instrumentation

Processing equipment and instrumentation are qualified for the operational parameters required for conducting development studies, and flexibility in processing a variety of products in a wide range of container/closure configurations.

  • Dedicated / disposable product contact items/equipment
  • Batch sizes to 40L (Aqueous / Organic Solvents)
  • Vials from 2 to 160 mL and novel delivery systems
  • Cartridges from 1 to 50 mL
  • Bulk Lyophilization or Drying
  • Containment capabilities for handling cytotoxic / high potent APIs including biologics and oncology products
  • Lyophilizers ranging from 2 ft² to 24 ft² (0.2 m² to 2.2 m²) (ISO 5 / Class 100 Environment)
  • ControLyo™, Nucleation On Demand
  • DEA Registration to handle Controlled Substances