The Right Capabilities.

The Right Capabilities.

CMC Biologics provides a comprehensive range of biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). We tailor our team and approach to each client’s needs, whether they be complete, turnkey manufacturing or specific, stand-alone services.

Our clients benefit from our years of experience with both antibody and non-antibody products. We have demonstrated the ability to successfully bring a product from DNA to market. For clients with fully developed processes, we provide manufacturing flexibility and capacity. For clients with product development needs, we provide strong knowledge base and in-depth experience with a full range of product development and analytical capabilities.

Project Management
At CMC Biologics, we believe in partnering with our clients, and we translate this philosophy into action within our project management team. Our project managers bring together a full range of services and experience to meet your needs.

Defined Team Structure Transparency Flexibility
Provides flexibility/speed Open communication Program changes
Facilitates collaborative relationship
  • Shared decision making
  • Joint problem solving
Candid information
  • Program progress
  • Budget/timeline
Project priorities

CHEF1® Expression System

CMC Biologics also offers a proprietary CHO cell line development platform called CHEF1. CHEF1 delivers stable, high-titer, production-quality cell lines in rapid time frames. It is the foundation of our approach to cell line development.

Services Overview:
  • Cell line/strain development
    • CHEF1 expression platform
  • cGMP cell banking
  • Process development – cell culture, fermentation, purification
    • Statistical tools
    • Quality by design
  • Process validation
  • Analytical development
  • Formulation development
  • Commercial and clinical cGMP manufacturing
    • Microbial fermentation
    • Mammalian cell culture
  • cGMP stability services
  • QA/QC/Regulatory services
Right. On time.