Our serum products are of the highest quality, and our processes have been perfected over our 40 year corporate history. Manufacturing processes include analyte specific screening, defibrination, diafiltration, delipidization, charcoal stripping, affinity stripping, and 0.22 micron final filtration.
- Plasma is collected from US FDA licensed blood collection facilities, with complete donor traceability; donor units are tested and found to be negative for all FDA required pathogens.
- Processing performed in a cGMP, FDA-registered facility whose quality management system is certified as conforming to the requirements defined in the ISO 13485:2016 Standard.
- Custom lots manufactured ranging from 1L to 2000L