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ChromaPlus™ is a patented, FDA-approved process used to manufacture Rhophylac®. This highly sophisticated process ensures the highest quality, safety, and purity.
View a video showing the ChromaPlus™ process in detail.
How ChromaPlus™ Works
The ChromaPlus™ process involves carefully calibrated phases that work cohesively to inactivate and remove enveloped and non-enveloped viruses. ChromaPlus™ has three complementary phases:
- Solvent/detergent (S/D) treatment: Inactivates enveloped viruses (HBV, HCV, HIV)
- Ion exchange chromatography: Isolates RhIgG and removes unwanted components, providing the purity that allows for IM and IV administration.
- Nanofiltration: Removes enveloped and non-enveloped viruses (HAV, parvovirus B19) through 15 nm filterpores
Most anti-D products are manufactured by a form of Cohn cold ethanol fractionation method developed in the 1950s, which may not completely clear aggregates of immunoglobulins. Those aggregates could cause problems for patients if administered intravenously, which is why most anti-Ds are for IM use only. Because of the ChromaPlus™ manufacturing process, Rhophylac® is aggregate-free, meaning it can be safely administered via IM or IV route.
Another key difference between ChromaPlus™ and Cohn fractionation—the process used to produce other anti-D products—is that chromatography maximizes donor plasma utilization by increasing the RhIgG yield.
ChromaPlus™:
- Results in high purity, allowing Rhophylac® to be administered IV or IM
- Produces excellent yields, maximizing donor plasma utilization
- Removes protein aggregates that can cause anaphylactic reactions in susceptible individuals
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