Company Description
A Contract Development and Manufacturing Organization focused on all aspects of Lyophilization. A talented and dedicated staff, skilled through experience, is coupled with in-house capabilities in product development, process engineering, clinical manufacturing and technical support. Recognized as an industry leader, the company has a proven reputation in providing innovative solutions, achieving desired results, and exceeding client expectations.
Markets Served
LTI has provided lyophilization-focused Development and Clinical Trial Material Manufacturing services to more than 296 biotechnology and pharmaceutical clients spanning from virtual, small to large multi-national companies over 20 years.
Capabilities
• Pre-clinical to Phase II Clinical Materials, lyophilized and liquid products
• Dedicated / disposable product contact items/equipment
• Containment capabilities for handling cytotoxic/high potent APIs
• Lyophilizers ranging from 0.2 m2
• Praxair ControLyo™, Nucleation On Demand NEW
Services
LTI has successfully developed formulations, manufacturing processes and prepared material for clinical trials for over 384 diverse products. • Anti-infectives • Human / Recombinant Biologics • Vaccines
• Oncolytics / HPCs • Small Molecules / Therapeutics •
Diagnostics
Development Sciences Distinct development and process laboratories provide ample capacity for small to medium scale formulating through fill and finish activities. Filling, stoppering and loading the qualified pilot-scale lyophilizers are completed in certified Class 100 clean rooms to emulate aseptic manufacturing conditions. • • •
Thermal Analysis Product Design
Formulation Development
• Cycle Design / Refinement • •
Product Characterization Toxicology Material
Clinical Manufacturing The Clinical Manufacturing Area (CMA) is flexible for preparation of products with unique requirements, adheres to aggressive project timelines, and is fully cGMP compliant. The dedicated CMA includes separate controlled areas for warehousing, preparing materials, compounding, fill / finish and inspection. The aseptic processing suite features containment and isolation technology. The operation has been inspected and approved for handling BSL-2 material. • •
Pre-clinical Phase I
• •
Phase II Liquid Fills
Technical Services Technical services are available providing support for all aspects of lyophilization. • Customized Training • Validation
• Investigations • Quality / Compliance
www.americanpharmaceuticalreview.com | | 19 to 4.5 m2
• Vials from 2 to 160 mL and novel delivery systems
• Cartridges/syringes from 1 to 50 mL • •
Bulk Lyophilization or Drying Batch sizes to 75L
• Drug & Device Registration/DEA license • US / EU compliant
NEW
www.lyotechnology.com
Lyophilization Technology, Inc. 30 Indian Drive Ivyland, PA 18974-1431 USA Tel: +1 (215) 396-8373 Fax: +1 (215) 396-8375 E-mail:
inquiry@lyo-t.com
LYOPHILIZATION TECHNOLOGY, INC.
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