Komal Khokhal

Lyophilization Technology, Inc

Lyophilization Technology, Inc. is a unique Technical Service and Contract Development and Manufacturing Organization. LTI provides comprehensive in-house capabilities ranging from thermal analysis, product design, formulation development, process engineering, streamlining operations, improving compliance, preclinical to Phase II clinical material preparation and technical support for a wide variety of products. LTI has successfully developed formulations, manufacturing processes and prepared material for clinical trials for a wide variety of products. • Anti-infectives • Biologics / Vaccines • Oncolytics / HPCs • Small Molecules / Therapeutics Development Services are conducted with product quality and a manufacturing mindset from the start, considering product administration, stability and processing requirements. Distinct processing areas are comprised of ISO 5 clean rooms directly linked to pilot-scale lyophilizers. Clinical Manufacturing Area (CMA) is flexible for preparation of products with unique requirements, adheres to aggressive project timelines, and is fully cGMP compliant. • Pre-clinical to Phase II Clinical Material • Dedicated / disposable product contact items/equipment • Combined aseptic processing with product containment • Vials 2 to 100 mL and novel delivery systems • US / EU complaint Technical Services The broad range of experience in a wide variety of products provides a specialized expertise from which you can capitalize.