Compass Biomedical offers contract research and manufacturing services to advance your cell, blood or tissue-based products. ​Our services can assist with advancement of products from early proof of concept studies to process development and GMP manufacturing and packaging. ​

Our Expertise

• Proven track record of program management for multi-million, multi-site projects taking products, ranging from early stage development through commercialization 
  
• Biologic Niche: We focus on Biologic Products such as Blood Components, Human Tissues and Cell Therapies 
  
• Established Supply Networks for cGMP blood and tissue products 
  
• Product Research and Development capabilities by a diverse team of scientists and engineers 
  
• On-site GMP manufacturing capabilities 
  
• Flexibility to meet clients’ specific requirements that may not be met by larger “check-the-box” CROs ​
  

Development

• Technology Transfer, Development, or Optimization of cGMP Compliant and Scalable Processes 
  
• Process and Product Development of Blood Products or Human Tissue Products  
  
• Formulation Development  
  
• Scale-up 
  

• Potency Assay Development 
  
• Cryopreservation and/or Lyophilization 
  
• Viral Reduction Validations ​
  

Manufacturing 

• Pre-clinical manufacturing 
• Early Phase I/II clinical manufacturing 
• Late phase and commercial manufacturing 
• Fill/Finish 
• Quality Management System (ISO 9001:2015) 

• Regulatory Guidance 
• CMC/Technical File preparation ​​​

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Testing

• Sterility testing (Bacterial and fungal) 

• Viral Safety testing 
• Potency 
• Custom Assay Development 
• In-Process and Release Testing
  

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 To learn how we can help you with your research or manufacturing needs, please contact us at 855-475-7587 or info@compassbiomed.com