Services
Bio-Process Engineering and Consulting
- Bio-Process Engineering
- Single-Use Technology Program Development
- Process/Product Development
- Bio-Process Applications Testing
- Quality Engineering
- Methods Development/Analytical Testing
Pilot Scale and Applications Lab
- Pilot Scale Manufacturing Operations Feasibility Testing
- Comparison Testing of Similar Unit Operations (Mixing, Cell Harvest, Transfection/Coinfection, Transduction, Filtration, Bioreactor, Chromatography, etc)
- Hold/Stability Testing
- Container Closure Testing (USP <1207>)
- Sterility Program Development for SUT Suppliers
- Mean Time Before Failure (MTBF) Testing
- Spallation Testing
- Mixing Characterization
- Forced Extraction (USP <665>)
- Endotoxin Testing (USP <85>)
- Bioburden Testing (USP <61> ,<62>)
- Particulate Testing (USP <788>)
Quality Engineering and Consulting
- Commissioning, Qualification and Validation (CQV)
- Quality Plan and Systems Development
- Shipper and Shipping Qualification
- Equipment and Automation Qualification
- Validation Master Planning
- User Requirement Specifications (URS) Development
Strategic and Innovative Engineering Solutions
Strategic BioEngineering Services
- Owner's Project Management for Capital Project Design Phases and Execution
- Project and Process Design Lead / Subject Matter Expertise across all Design Phases and Disciplines
- Master Planning for Biotech and Pharma
- Master Planning for Environmental Sustainability
- Master Planning for Industry 4.0 Strategic Initiatives for Digital Transformation
Manufacturing Process Improvement
Our team can analyze your current manufacturing processes and identify areas for improvement, helping you increase efficiency and reduce costs.
"Right Sized" Automation Strategy Development
We can help you develop software solutions for everything from embedded systems to control and automation systems, ensuring that your products are reliable and efficient.
Consulting and Training
We offer comprehensive consulting and training services to help you with everything from process/product design to manufacturing process improvement and technology transfer, ensuring that your team has the skills and knowledge they need to succeed.