A Collaborative Approach
With decades of proven experience developing, manufacturing, and marketing high-quality products for hemostasis diagnostics and research, Precision BioLogic and our subsidiary Affinity Biologicals have the knowledge and expertise to help you grow your business. We’re here to help at any stage of your product life cycle.
- Research and development
- Custom manufacturing
- Contract services
- Field research studies
- Antibody production
- Custom lyophilization
- Plasma depletion
Contact us to discuss how we may put our expertise to work for you.
CASE STUDY: Global Biotechnology Company
THE PROBLEM: A global biotechnology company with a new factor replacement therapy drug sought Precision BioLogic’s expertise in understanding possible testing variability.
THE SOLUTION: A series of collaborative discussions led to the idea of creating a laboratory sample kit and running a research study to help identify laboratories that may not be measuring the drug accurately. Using its research and manufacturing expertise, Precision BioLogic created the kit and led a US-based research study, which proved very informative.
THE RESULT: Success of the initial study led to studies in two other countries and the subsequent sharing of results with the patient and diagnostics communities along with publications at multiple symposia.
CASE STUDY: Point of Care Manufacturer
THE PROBLEM: A Point of Care (POC) manufacturer developed a new instrument for monitoring a blood/plasma-based analyte. To bring the device to market, the manufacturer needed separate standalone Quality Control reagents that were cleared as diagnostics and validated on the instrument.
THE SOLUTION: Product development teams at Affinity Biologicals and the manufacturer collaborated on the design and development of a freeze-dried plasma product. Affinity Biologicals’ expertise in manufacturing on a small-scale pilot level was exactly what was needed to narrow down the specifications of the reagents so that the ideal controls were developed. The ability of Affinity’s staff to work closely with the manufacturer to then take the small-scale pilot through to validation and full-scale manufacturing, while navigating regulatory compliance, was essential for the project’s success.
THE RESULT: Two diagnostic reagents were developed to work flawlessly on the new POC device and the smooth timeline from design to release allowed the manufacturer to bring their device to market without delay.