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

Aseptic PallayPack Monoblock Filling Station

​VirTis Genesis 35EL Lyophilizer

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