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


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Lyophilization Technology, Inc.

  • Country/Region:
    United States
  • On CPHI since:
    2017
Company types
Contract Service
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Categories
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Specifications
  • Selling Points
    Convenience; Experienced Technicians; Quality Service; Reputation
  • Supplied from
    United States
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Sales Markets
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Lyophilization Technology, Inc.

  • Country/Region:
    United States
  • On CPHI since:
    2017
Company types
Contract Service
View company profile

More Products from Lyophilization Technology, Inc. (2)

  • 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...
  • 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.

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Lyophilization Technology, Inc. resources (1)

  • Introduction

    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.