COMPREHENSIVE SERVICES FOCUSED ON LYOPHILIZATION
Lyophilization Technology, Inc. (LTI) was formed in 1992 to provide an extensive range of scientific services and technical support in freezing and freeze drying. As a Contract Development and Manufacturing Organization (CDMO), our services range from product and process development and integration of a new product and process into commercial manufacturing operations through clinical trial material preparation. With our expertise, you realize the benefit from development, clinical material manufacturing, technical support, consulting services, improved quality, efficiency, and compliance for new and commercial lyophilized products.
• Development Studies
• Pilot Plant Scale-up
• Design Space Studies
• Clinical Trial Material
• Consulting
• On-site Training
DEVELOPMENT SCIENCES
Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale manufacturing environment. This now includes use of ControLyo, Nucleation On Demand technology, in process engineering studies. Critical areas for fill/finish are all within a certified HEPA environment, emulating aseptic operations for sterile product. Our comprehensive development reports readily support your regulatory submissions.
• Low Temperature Thermal Analysis
• Product Development
• Cycle Design / Refinement
• Vials/Cartridges
• Finished Product Testing
• Isolation / Containment
• Aqueous / Organic Solvents
CLINICAL MANUFACTURING
Toxicological and clinical parenteral products are prepared in the Clinical Manufacturing Area (CMA), a unique aseptic fill/finish facility with isolation and containment capabilities using disposable and dedicated equipment. This area allows processing of BSL-2 biologicals, controlled substances, highly potent compounds and oncolytics. Stringent environmental controls within this unique facility allow for a superior level of purity in the finished product.
• Aseptic Processing
• Isolation / Containment
• Disposable / Dedicated Equipment
• Qualified / Validated
• US and EU Compliant
Preparation of clinical material accompanying the extensive activities performed in the development laboratory and pilot plant provides a single source for an expedient and effective pathway into clinical studies. Batch preparation, aseptic processing and lyophilization are completed in a unique aseptic containment environment that provides quality and purity, in addition to safety and security for product and personnel.
• Sterile Bulk and Drug Product
• 2 to 160cc presentations
• 13 to 28mm closures
• Temperature controlled compounding and filling
• ControLyo, Nucleation On Demand
• Aqueous / Organic Solvents
• 8 to 48 ft2 (0.7 to 4.4 m2) Lyophilizers
TECHNICAL SERVICES
Complementing development sciences and clinical manufacturing, technical services include consultation on equipment specifications, scale-up, quality control, validation, and compliance auditing. On-site training is available in the fundamentals of lyophilization and validation.
WHEN YOUR NEEDS ARE LYOPHILIZATION, OUR FOCUS IS ON YOUR PRODUCT…
Please visit www.lyotechnology.com or call us to discuss your project needs.
Lyophilization Technology, Inc. (LTI) was formed in 1992 to provide an extensive range of scientific services and technical support in freezing and freeze drying. As a Contract Development and Manufacturing Organization (CDMO), our services range from product and process development and integration of a new product and process into commercial manufacturing operations through clinical trial material preparation. With our expertise, you realize the benefit from development, clinical material manufacturing, technical support, consulting services, improved quality, efficiency, and compliance for new and commercial lyophilized products.
• Development Studies
• Pilot Plant Scale-up
• Design Space Studies
• Clinical Trial Material
• Consulting
• On-site Training
DEVELOPMENT SCIENCES
Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale manufacturing environment. This now includes use of ControLyo, Nucleation On Demand technology, in process engineering studies. Critical areas for fill/finish are all within a certified HEPA environment, emulating aseptic operations for sterile product. Our comprehensive development reports readily support your regulatory submissions.
• Low Temperature Thermal Analysis
• Product Development
• Cycle Design / Refinement
• Vials/Cartridges
• Finished Product Testing
• Isolation / Containment
• Aqueous / Organic Solvents
CLINICAL MANUFACTURING
Toxicological and clinical parenteral products are prepared in the Clinical Manufacturing Area (CMA), a unique aseptic fill/finish facility with isolation and containment capabilities using disposable and dedicated equipment. This area allows processing of BSL-2 biologicals, controlled substances, highly potent compounds and oncolytics. Stringent environmental controls within this unique facility allow for a superior level of purity in the finished product.
• Aseptic Processing
• Isolation / Containment
• Disposable / Dedicated Equipment
• Qualified / Validated
• US and EU Compliant
Preparation of clinical material accompanying the extensive activities performed in the development laboratory and pilot plant provides a single source for an expedient and effective pathway into clinical studies. Batch preparation, aseptic processing and lyophilization are completed in a unique aseptic containment environment that provides quality and purity, in addition to safety and security for product and personnel.
• Sterile Bulk and Drug Product
• 2 to 160cc presentations
• 13 to 28mm closures
• Temperature controlled compounding and filling
• ControLyo, Nucleation On Demand
• Aqueous / Organic Solvents
• 8 to 48 ft2 (0.7 to 4.4 m2) Lyophilizers
TECHNICAL SERVICES
Complementing development sciences and clinical manufacturing, technical services include consultation on equipment specifications, scale-up, quality control, validation, and compliance auditing. On-site training is available in the fundamentals of lyophilization and validation.
WHEN YOUR NEEDS ARE LYOPHILIZATION, OUR FOCUS IS ON YOUR PRODUCT…
Please visit www.lyotechnology.com or call us to discuss your project needs.
Focus Areas
BIO DOUBLE HELIX SPONSORS
BIO HELIX SPONSORS
