Biotechnology Product Development Offerings

Kymanox gives you peace of mind by providing technical experience to make your biologics, cell and gene therapy, or vaccine product a success.

Design, Development, & Testing

  • • Product & Process Development
  • • Human Factors Engineering
  • • Design Control & Risk Management
  • • Test Engineering
  • • Design & Innovation Services
  • • Formulation Engineering
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    Quality & Compliance 

  • • Quality Assurance
  • • Audit/PAI Readiness
  • • Clinical & Medical
  • • Post Market Surveillance
  • • Complaint Management
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    Facilities & Manufacturing

  • • Automation
  • • Facility/Utility Engineering
  • • Validation(CQV)
  • • ERP & Computer System Validation (CSV)
  • • Packaging Technology & Engineering
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    Technical Operations

  • • CMC
  • • Process Engineering
  • • Microbiology & Analytical Sciences
  • • MS&T
  • • Supply Chain & Logistics
  • • Tech Transfer
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    Regulatory Affairs

  • •Advisory Services
  • •Regulatory Submissions
  • •Regulatory Body Interactions
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    Executive Support & Strategy

  • •Program & Project Management
  • •Executive Advisors (KEA)
  • •Due Diligence
  • •Staffing
  • •Hyper-Virtual Model
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    Biotechnology Products & Services Where We Excel

    Extracted from living systems

    Produced from Living Systems

    Produced from Living Systems

    • • Whole blood and other blood components
    • • Stem-cell therapy
    • • Antibodies for passive immunity

    Produced by Recombinant DNA

    Produced by Recombinant DNA

    • • Key signaling proteins (nearly) identical to those found in the body
    • • Monoclonal antibodies
    • • Receptor constructs (fusion proteins)

    Vaccines

    Vaccines

    • • Viral (live or inactivated)
    • • Viral vector
    • • Subunit (protein or polysaccharide)
    • • Nucleic acid (DNA or RNA)

    Cell and Gene Therapy

    Cell & Gene Therapies

    • • Process Development
    • • Clinical Trial Material (CTM) Oversight and Planning
    • • Packaging Technology and Engineering
    • • Regulatory Filings

    Contract Development & Manufacturing Organizations (CDMO) 

    CDMO

    • • Evaluation & Selection
    • • Management
    • • Tech Transfer