Biologics & Cell and Gene Therapy Services

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

Development & Operations

  • • Product & Process Development
  • • CMC Services & Analytical Sciences
  • • Process Engineering
  • • Human Factors Regulatory & Strategy (HURAS)
  • • Packaging Technology & Engineering
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    Quality, Regulatory, & Compliance 

  • • Quality Assurance, Compliance, & Auditing
  • • Quality Engineering
  • • Quality Control
  • • Regulatory Affairs
  • • Clinical & Medical Affairs
  • • CGxP Microbiology & Environmental Monitoring
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    Commissioning, Qualification, & Validation

  • • Validation Master Planning
  • • Facilities & Utilities CQV
  • Lab & Plant Equipment CQV
  • • Computer System Validation (CSV)
  • • Process Validation
  • • Cleaning Validation
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    Strategy, Planning, & Execution

  • • Program & Project Management
  • • Technology Transfer
  • • Innovation Solutions
  • • Enterprise Resource Planning & Solutions
  • • Due Diligence
  • • Staffing Solutions
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    Biologics & Cell and Gene Therapy Products & Services Where We Excel

    Extracted from living systems

    Extracted from Living Systems

    Extracted 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)



    • • 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) 


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

    Kymanox Biologics & Cell and Gene Therapy Resources

    Perspective Article: Key Packaging Challenges to Consider in Cell and Gene Therapy

    Although the primary focus of biopharmaceutical companies is on the development and manufacturing of the drug product (DP) and the delivery systems (e.g., syringes), packaging and labeling are key to ensuring product quality and efficacy. Packaging, labeling, and distribution of cell and gene therapy products can be as complicated, if not more, than the manufacturing of the DP itself.

    Meet our Biologics Experts

    Nick Schill, PhD

    Frequently Asked Biologic Questions (FAQs)

    Can I just outsource this work to Kymanox?
    In short, yes.  Kymanox has a flexible approach with our clients that is based on the unique needs of that particular situation.  In some situations we basically act as employees of our clients, effectively acting as a functional department within their company.  You can’t tell a Kymanox employee apart from our clients in these situations.  We have additional options to meet your needs for cell and gene therapy as well. One advantage to the Kymanox approach is that we empower our team of full-time employees and contractors with access to our entire team of experts, so when you hire Kymanox, you get the benefit of our collective experience. We invite you to learn more about our Staffing Solutions.      
    I have a pretty big project. Can Kymanox handle it?
    Kymanox has extensive experience on multi-million dollar projects at some of the largest pharmaceutical, biologics, and medical device companies in the world.  Our processes were built with the ability to scale to meet the needs of a virtual biotech startup, the largest of big pharma, and everything in between.  One key to our success is our Program & Project Management team, our secret weapon in making sure we stay on track with our agreed upon scope and keeping clients informed so they can rest easy knowing there will be no surprises.  Our approach is flexible, so you’ll get just the right amount of project management for your cell and gene therapy needs. 
    What is Ideal Knowledge Transfer™?
    Ideal Knowledge Transfer™ (IKT™) is a continuously improving concept that seeks to address the knowledge transfer process in a formal and structured way where end-goal success can be predicted and measured.  IKT™ builds on existing principles and disciplines, such as professional project management, fundamental engineering practices, universally recognized quality systems, and formal problem solving methods.  Leveraging our corporate DNA of IKT™, our talented team partners with global clients to facilitate development and delivery of products with optimized safety, quality, efficacy, accessibility, and efficiency.  To learn more about IKT™ please visit our IKT blog post.