Lyophilization Technology, Inc.
30 Indian Drive
Ivyland, PA 18974-1431
T: (215) 396-8373
F: (215) 396-8375
E: inquiry@lyo-t.com
W: www.lyotechnology.com

WHO WE ARE

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. Capitalize on over 25 years of excellence and our unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.

MAJOR MARKETS

Biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations, along with universities and research institutes have engaged our support in successful collaborations for a variety of projects. These projects span initial product and process development for new entities right out of drug discovery through Phase I/II clinical material, to technology transfer to commercial manufacturing with regulatory approval. Gaining a global reputation, LTI has been sought after and completed projects with clients in the European, Middle East, and Asian Pacific regions, as well as North America.

SERVICES OFFERED

Capabilities

• Pre-clinical through Phase II Clinical Materials
• Bulk Lyophilization
• Dedicated/disposable equipment
• Batch sizes: up to 75L
• Vials: 2 to 160 mL
• Dual Chamber cartridges and syringes: 1 to 20 mL
• Novel delivery systems
• Nucleation On-Demand Technology
• DEA license
• US/EU compliant 

LTI successfully develops formulations, processes or prepared clinical material for many diverse products, including:

• Biologics (up to BSL-2)
• Oncolytics
• Liposomes
• Anti-Infectives
• Peptides/Polypeptides
• Proteins/mAbs
• Diagnostics
• Nanoparticles/Emulsions
• Vaccines and VLPs
• Controlled Substances
• Highly Potent Compounds
• Antibody Drug Conjugates
• Devices/Delivery Systems
• Small and Large Molecules

Development Sciences

Development Sciences focuses on formulation through finished product characterization. The Process Lab provides capacity for small to medium scale lyophilization. Filtration, filling, stoppering, and loading the qualified pilot-scale lyophilizers are in certified Class A/100 environments, emulating aseptic manufacturing conditions.

 

 

 

• Product Design
• Formulation Development
• Thermal Analysis
• Cycle Design/Refinement
• Product Characterization
• Pilot Plant Scale-up
• Isolation/Containment
• Cartridges

Clinical Manufacturing

US/EU compliant Clinical Manufacturing Area (CMA) for preparation of clinical material enables us to process a wide range of products, including those having unique requirements. The CMA includes an aseptic suite featuring advanced containment/isolation technology using unique disposable negative pressure isolators inspected and approved for handling BSL-2, cytotoxic and highly potent compounds. LTI has also developed the technology that allows us to freeze dry product in both dual chamber cartridges and pre-filled syringes.

• Aseptic compounding
• Pre-clinical through Phase II
• Toxicology Material Processing
• Small to medium batch sizes
• Liquid/diluents
• Dual chamber cartridges/syringes 

Technical Services

Technical services are available providing support for all aspects of lyophilization.

• Customized Training
• Consulting on equipment specifications
• Process requirements
• Guidance on CMC submission
• Support on IQ/OQ and process validation
• Technology transfer
• Process excursions
• Product and process troubleshooting
• Batch record review
• Compliance auditing