Compass Biomedical offers comprehensive services from research and development through manufacturing to provide you a one-stop-shop for advancement of products from proof of concept to product commercialization. 

​We provide contract research and manufacturing services (CRAMS) 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 Advantages

• Proven track record of taking products from early stage development through commercialization
• Focus on Biologic Products such as Blood Components, Human Tissue and Cell Therapy
• Product Research and Development capabilities by a diverse team of scientists and engineers
• On-site manufacturing capabilities
• GMP Product Fill and Finish capabilities
• Regulatory Support and Quality System development
• Flexibility to meet clients’ specific requirements that may not be met by larger “check-the-box” CROs
• ​Proven track record of program management for multi-million, multi-site projects

Our Expertise

Research and Development

Management

• Scientists and Engineers with diverse scientific background
• Extensive clinical, translation, and pre-clinical experience
• Established network of subject matter experts
• Proven track record of securing grant funding: total funding > $40 million

• Proven track record of program management for multi-million, multi-site projects
• Experience with contract negotiations and military & industry partners

Manufacturing and Packaging

cGMP Fill and Finish

Supply Chain and Packaging

• Freeze Dried Blood Cells (aseptic)
• Growth Factor Proteins
• Bio-active Bandages
• Eye Drops​

• 12’ x 16’ Aseptic ISO Class 5 Clean Room
• ISO Class 7 gowning area
• Recommended by ISPE, ISO, and FDA

​VirTis Genesis 35EL Lyophilizer

Aseptic PallayPack Monoblock Filling Station

Flexible Configuration

•   Eye Dropper
•   Drug Vials
•   Can be retro-fitted for other products  

Automated

•   Vial feed & filling (40 vials/min)
•   Stopper placement for lyophilization
•   Capping & crimping

• -70°C lyophilizer
• Holds up to 35L
• Automatic stoppering system
• Prints batch reports
• cGMP lyophilization runs

You cannot inspect quality into a product, you must design your products with quality in mind.

Regulatory and Quality Expertise

Clinical and Regulatory

Standard Operating Procedures (SOPs)

We assist with all aspects of regulatory affairs

• 4 –Person dedicated regulatory team
• Pre-IDE/IND FDA meetings and applications
• 510(k), PMA, NDA Submissions
• Import/export certifications
• Document control and data management
• Technical File preparation

Quality Assurance

• Traceability
• Quality Control Plan
• Inspections
• Internal Compliance Monitoring 

• Incoming Inspections
• Labeling
• Batch/Lot Release
• Quality System Investigations
• CAPA
• Environmental Monitoring
• Cleaning
• Validation records
• Risk Management