About LTI
Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.
Clients leverage on our abilities for bringing new products to the clinic and implementing improvements for current products. LTI is recognized as an industry leader with unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.
To the benefit of our clients, LTI has provided Development and Clinical Trial Material Manufacturing services to more than 500 biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations for over 25 years. Our proven track record of performance comes from successfully developing formulations, manufacturing processes, and prepared material for clinical trials for over 900 diverse products.
A talented and dedicated staff, skilled through over 300 years of combined experience, enjoys the reputation of providing innovative solutions, achieving desired results, and exceeding client expectations.
Gain the benefits of our experience and capabilities for creating solutions for the unique needs of your lyophilized product.
Markets Served
LTI provides Development and Clinical Trial Material Manufacturing to more than 354 biopharmaceutical companies spanning virtual, small, large and multi-national companies. Gaining an international reputation, projects are with clients in US, Canada, Mexico, Eastern and Western Europe, Australia and Japan.
Capabilities
- Pre-clinical through Phase III Clinical Materials, lyophilized/liquid products
- Containment for cytotoxic/high potent productsDedicated/disposable equipment
- Vials: 2 to 160 mL: novel delivery systems
- Cartridges/syringes: 1 to 50 mL
- Lyophilizers: 0.2 m2 to 4.5 m 2
- Praxair ControLyo™
- Bulk Lyophilization
- Batch sizes: up to 75L
- Drug and Device Registration/ DEA license
- US/EU compliant
Services
LTI successfully developed formulations, processes or prepared clinical material for over
- 493 diverse products:
- Anti-infectives
- Human/Recombinant Biologics
- Vaccines
- Nanoparticles/emulsions
- Oncolytics/HPCs
- Small Molecules/Therapeutics
- Diagnostics
- Bioengineered materials
Development Sciences
Development Sciences lab focuses on formulation through product characterization. The Process Lab provides capacity for small/medium scale lyophilization. Filtration, filling, stoppering and loading qualified pilot-scale lyophilizers are in certified Class 100/Grade A environments, emulating aseptic manufacturing conditions.
- Thermal Analysis
- Product Design
- Formulation Development
- Product/Process Feasibility
- Validation
- Cycle Design/Refinement
- Product Characterization
- Toxicology Material
- Stability Batches
Clinical Manufacturing
US/EU compliant Clinical Manufacturing Area (CMA) for preparation of clinical material is for processing a wide range of products, including unique requirements. The CMA includes an aseptic suite featuring unique disposable negative pressure isolators for containment/isolation technology, inspected and approved for handling BSL-2, cytotoxic and highly potent material.
- Aseptic compounding
- Pre-clinical through Phase III
- Small to medium batch sizes
- Liquid/diluents
Technical Services
Technical services are available providing support for all aspects of lyophilization.
- Customized Training
- Qualification/Validation Support
- Investigations
- Quality/Compliance