Clinical Supply Manufacturing Services

Clinical Supply Manufacturing Services
Product Description

Lyophilization Technology, Inc. offers clinical supply manufacturing. It is capable of processing sterile pre-clinical to phase II clinical materials, lyophilized and liquid products in vials, cartridges, bulk, or unique delivery system. Containment capabilities include handling biologicals, cytotoxic, and high potent APIs. It includes separate controlled areas for warehousing, preparing materials, compounding, filling, inspecting and packaging. The aseptic processing suite features hepa filtered unidirectional air supply and returns, containment capabilities and isolation technology. The operation has been inspected and approved to handle BSL-2 materials and qualified for containment and aseptic processing. Stringent environmental controls within our facility allow for a superior level of purity in finished product.


• Aseptic Processing
• Isolation / Containment
• Disposable / Dedicated Equipment
• Qualified / Validated
• US and EU Compliant


Lyophilization Technology, Inc.

  • US
  • 2017
    On CPhI since
Contract Service
Specifications
  • Selling Points
    Convenience; Experienced Technicians; Quality Service; Reputation
  • Supplied from
    United States

Lyophilization Technology, Inc.

  • US
  • 2017
    On CPhI since
Contract Service

More Products from Lyophilization Technology, Inc.

  • Development Sciences

    Product 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 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

  • Technical Services

    Product 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.

           • Equipment IQ / OQ
           • Consulting and Auditing
           • Troubleshooting
           • Products / Processing Evaluation
           • Equipment Specifications
           • Process / Cycle Evaluation
           • Quality / Compliance Support
           • On-site / In-house Training

Lyophilization Technology, Inc. resources

  • Brochure Introduction

    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 our abilities for bringing new products to the clinic and implementing improvements for current products. LTI is recognized as an industry leader with unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.

  • Brochure Mission Statement

    Our Aspiration-The successful application and technological development of lyophilization.Our Goal-The development and preparation of lyophilized products that improve the quality of life.Our Endeavor-Embrace a responsibility and commitment to those we serve, work with, and who share our aspirations.
  • Brochure Services and Capabilities

    Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.

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