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Lyophilization Technology, Inc. sell "Development Sciences"

Basic Information

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Trade Type

Sell

Service Name

Development Sciences

Specifications

  • Application: Biopharmaceutical development, manufacturing or analytical support service
  • Certification Standard: Manufactured under cGMP with full batch traceability and lot-release testing
  • Regulatory Status: Supports regulatory submissions (e.g., BLA/MAA/NDA) in accordance with ICH guidelines

Other Information

Additional Description:

Development laboratories are equipped to run a diverse range of experiments spanning formulation development, cycle design and process refinement, and finished product evaluation. Process development studies conducted within a pilot-scale manufacturing environment, including the use of ControLyo technology in process engineering studies, ease scale-up. Critical fill/finish areas operate within a certified HEPA environment that emulates aseptic operations for sterile products, and comprehensive development reports readily support regulatory submissions. Capabilities include low-temperature thermal analysis, product development, cycle design/refinement, vial and cartridge work, finished product testing, isolation/containment, and work with aqueous and organic solvents.
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