Pharmaceutical Lyophilization Testing
OFD Bio|Pharma has the expertise necessary to create solutions for a variety of testing needs unique to each project. If development and maintenance of materials is needed, we can help you perform the necessary testing for your program.
Testing for impurities in new materials may include:
- Confirmation of presence, identity and retention for raw materials and final product: FTIR, HPLC, GC, melt point (mp) via mech test.
- Test methods transfer, development and validation of raw materials and final product parameters.
- DSC, melt point, Microbial Analysis including speciation and bioburden: CFU’s determined (active and inactive)
- Moisture/Solids – Thermo gravimetric & Karl Fischer testing
- Concentration: determined with UV-vis, HPLC
- Residual Impurities – ICP, HPLC, FTIR
- Degradation analysis
- Dissolution testing
- Stability – Shelf-life testing [coordinated]
- LYP and QDT – Friability (disintegration testing, physical sizing)
Located on our main campus in Albany, OR, Oregon Freeze Dry has a new low bioburden ISO 5 BSL2 facility where we can safely develop Lyo-cycles for your custom product or material. In addition to smaller scale programs in the new Research and Development facility, we have our bulk lyophilization dryers that can scale production and meet product demand at levels that are unique to OFD|BioPharma.
This Research and Development facility features:
- Millrock pilot scale dryer
- Clinical dryer [1/10 scale]
- Commercial dryer
- Aseptic clean rooms
- World-class infrastructure to help develop and commercialize your product.
- State of the art lab for materials testing and validation.
OFD Bio|Pharma is on the cusp of introducing a proprietary new delivery system for materials that will revolutionize the lyophilization market. We can lyophilize small precise quantities 5ul to 250μl. Our precision process allows us to reliably produce precise dosing of your targeted product
Featured Case Study
Nutritional Supplement Probiotic Viability
A leader in the probiotic nutritional supplement space recently approached us and asked if we would be willing to participate in a shelf life viability comparison study using two of their probiotic strains.
Let’s Win Together
For over 50 years OFD has set the standard of excellence in Lyophilization. We’re ready to apply our experience and unique manufacturing capabilities to find a successful, scalable solution to address your unique preservation challenge.