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Compass Biomedical
  • Home
  • About
    • Management Team
  • Products
    • PLUS Human Platelet Lysate
    • BioBandage
  • Services
    • Resources Available
  • Newsroom
    • Compass Blog
  • Careers
  • Online Order Form
  • Contact Us
    • Distributors
  • Customer Referral

Contract Research and Manufacturing Services

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


​45 South Street Hopkinton, MA 01748, USA
Email: info@compassbiomed.com
Phone: 855-475-7587
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Copyright© 2017 Compass Biomedical, Inc. All rights reserved.
  • Home
  • About
    • Management Team
  • Products
    • PLUS Human Platelet Lysate
    • BioBandage
  • Services
    • Resources Available
  • Newsroom
    • Compass Blog
  • Careers
  • Online Order Form
  • Contact Us
    • Distributors
  • Customer Referral