cGMP

Contract Manufacturing 
& Cryopreservation Services

Provia’s state of the art laboratory and biorepository facility operates under the US Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (cGMP) guidelines.

LABORATORY
Services

  • Contract cGMP cell development and manufacturing services: 
    Custom cGMP autologous manufacturing setup and operation necessary in the preparation of human cells and tissues for therapeutic use.
     

  • Contract laboratory services:
    Optimized for small batch manufacturing, available for pre-clinical proof of concept studies to biotech, biopharma and cellular therapy industries.
     

  • Process and protocol development: 
    Assist in the development and validation of research and clinical cell processing protocols.
     

  • Cryopreservation services:
    Validated and monitored offsite specimen storage. Short and long term solutions for specimen storage at multiple temperatures.
     

  • Specimen supply chain: 
    Collect, transport, process, secure, and distribute.
     

  • Sample preparation:
    Nucleic acid extraction and aliquoting services.

CONSULTING
Services

Utilizing its extensive experience in stem cell technology, cGMP autologous cell manufacturing, and biobanking, our team of PhDs, MBAs, and informatics professionals provide clients with consulting services.  

Examples include, but not limited to:

  • Planning and overseeing the development of cGMP cell manufacturing facilities
     

  • Quality Management System Review
     

  • Defining market demand and building a business plan for a biobanking program's launch of a new service
     

  • Gathering business requirements for the development and deployment of an enterprise biobanking sample logistics system
     

  • Defining clinical data collection requirements for a research biorepository
     

  • Specimen collection site reviews and vendor audits
     

  • Global survey of biobank economics
     

  • Development of Biobanking software tools for planning and running a biobank
     

  • Specimen kit design
     

  • cGMP Kit Production and Logistics
     

  • Guidance on bioethics and legal aspects of human subjects research
     

  • Project, budget, and implementation planning
     

  • Collection and delivery of specified donated research samples (prospectively collected)

PROVIA LABORATORIES, LLC

11A Beaver Brook Road
Littleton, MA 01460
United States

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(855) 444-2280

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