Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication

COMPANY DESCRIPTION

Since 1992, Lyophilization Technology, Inc. (LTI) has provided development services and technical support focused on lyophilized products to the health care industry. The company has a proven reputation in providing innovative solutions, successfully completing projects, and exceeding client expectations.

A talented and dedicated staff possesses extensive experience in product development, process engineering, and technical support. In its history, LTI has provided services and support to companies spanning start-up, virtual, and multinational companies. Serving as a vital scientific and technical resource to your company, LTI has experience with a wide variety of products including small
molecules, biologicals, vaccines, medical devices, and diagnostic agents. Such expertise, combined with applying the latest technology, is what you expect from an industry leader.

FACILITIES

Continued growth and expansion of services encompass capabilities for oncologic and highly potent compounds, as well as controlled substances and biological level 2 preparations.

Over 8,000 square feet is dedicated to development and testing laboratories, a pilot plant, as well as, a unique aseptic containment processing area. Seven pilot scale lyophilizers, each having a segregated Class 100 processing area, are equipped with instrumentation, process controls, and data acquisition systems paralleling commercial manufacturing equipment. Principles of GMPs are applied to development and processing activities to ensure impeccable quality standards, delivering you a superior product and excellence in process design.

SERVICES & CAPABILITIES

A comprehensive range of services consists of development and optimization for lyophilized products and processing. Such services capitalize on the use of qualified laboratory facilities and include thermal analysis, product design, formulation development, process engineering, design space studies and
clinical material preparation. The laboratories are well equipped for conducting a diverse range of experiments as well as assessing finished product attributes.

Technical services encompasses consultation on equipment specifications, technology transfer, validation, product and process evaluation, troubleshooting, and compliance auditing. Quality and Regulatory Support along with in-house training in the fundamentals of the technology and validation are also available.