AQUA has subject matter expertise in life science related technologies and manufacturing processes. We offer consulting services to clients in the greater life science industry including:

• CAPA Investigations – Some CAPAs take on a life of their own and require outside resources to determine the root cause. We are here to help!
• Quality by Design (QbD) – During review, regulators like to see that your process is robust and that the parameter space is adequately explored. We help with risk assesments, process analytical technologies (PAT), design of experiments (DOE), and data analysis.
• Quality Compliance – Make sure everything is ready for your next audit by having the house in order, including a review of your nonconformances, CAPA investigations, and critical process parameter ranges. We will identify the gaps in your processes and devise a mitigation strategy.

Our past projects have involved Biologics, Drug Delivery Systems, Biomaterials, Cell Culture, Bioreactors, Downstream Purification, Cancer Immunotherapy, Bioconjugation, Biosensors, Medical Devices and Diagnostics (ELISA and DNA based), Regenerative Medicine, and Skin Care.

Contract Services

We offer contract services to customers who seek expert technical advice, product prototyping, and process development for projects including:

• Conjugation – antibody conjugates; binding to magnetic beads and other (nano)particle substrates
• Biomaterials – animal-free material; natural and synthetic polymers with customer specific functionality
• Cell Culture – enhance cell attachment and growth rate; custom hydrogel synthesis for stem cells, cancer immunotherapy virus production/purification, and more
• Delivery Systems – transdermal, pulmonary, and sublingual
• Biosensors – biomolecule immobilization (DNA/protein) and stabilization

We also manage early stage research and development projects through pilot production and pre-clinical testing.