Carolyn Hartman-Rakus's Contact Details

Carolyn Hartman-Rakus's Company Details

Lyophilization Technology

Warminster, PA, US • 50 - 99 Employees
Major Drugs

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 complaintTechnical ServicesThe broad range of experience in a wide variety of products provides a specialized expertise from which you can capitalize.