ChromaPlus™ Manufacturing Process

ChromaPlus™ is a patented, FDA-approved process used to manufacture Rhophylac. This highly sophisticated process ensures a product with high quality, safety, and purity. The risk of transmission of infectious agents cannot be completely eliminated.

Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions.

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:

  1. Solvent/detergent (S/D) treatment: Inactivates enveloped viruses (HBV, HCV, HIV)
  2. Ion exchange chromatography: Fractionates RhIgG while removing contaminants and unwanted components, providing the purity that allows for IM and IV administration.
  3. Nanofiltration: Removes enveloped and non-enveloped viruses (HAV, parvovirus B19) through 15 nm filterpores

Because of the ChromaPlus™ manufacturing process, Rhophylac is aggregate-free.


  • Allows for a highly pure product, allowing Rhophylac to be administered IV or IM
  • Produces excellent IgG yields, maximizing donor plasma utilization
  • Removes contaminants, such as protein aggregates
Home About Rhophylac ChromaPlus™

Important Safety Information

Rhophylac®, Rho(D) Immune Globulin Intravenous (Human), is a blood-derived injection given to women with an Rh-negative who might have an incompatible pregnancy—that is, who may be carrying an unborn child with Rh-positive blood. If a woman in such a pregnancy is not treated, the result could be “isoimmunization,” a condition in which the mother’s Rh-negative blood produces antibodies that could attack the unborn child’s Rh-positive blood cells, potentially creating serious health problems for the unborn child and any future children of the mother.

Rhophylac is given by physicians as routine protection against immunization, typically as administration during pregnancy, often with readministration within 72 hours following childbirth. It is also given in cases of obstetric complications, invasive procedures during pregnancies, incomplete pregnancies, and obstetric manipulative procedures in certain non-pregnant women. Rhophylac is also used in Rh-negative individuals who have received blood components containg Rh(D)-positive red blood cells. For suppression of Rh isoimmunization, Rhophylac can be administered intravenously or intramuscularly, but must not be given to newborn infant.

You should not receive Rhophylac if you have had a previous serious allergic reaction to Rhophylac or other human blood products. It should not be given if your blood has an insufficient quantity of a protein called IgA, has produced antibodies to IgA, or you have known hypersensititivy to IgA. Your physician will do a blood test to assess your situation regarding IgA.

Some women have experienced mild and temporary actions after receiving Rhophylac, such as fever; overall discomfort or uneasiness; headache; skin reactions (like hives or welts); and chills. If you received Rhophylac as a shot (intramuscularly), you could experience pain or tenderness at the injection site. Adverse reactions to Rhophylac typically do not last long. Discuss with your doctor any reaction or symptom you experience after administration of Rhophylac that concerns you.

Rhophylac is made from donated human blood. The risk of transmission of infections agents, including viruses, cannot be completely eliminated.

Immunoglobulin administration can transiently interfere with your response to live vaccines, such as measles, mumps and rubella. (Note that most influenza vaccines are not “live” vaccines.) Tell your doctor if you plan to receive a vaccine after receiving Rhophylac.

Please see full prescribing information for Rhophylac, which includes a boxed warning that does not apply to use of Rhophylac in pregnancy or in cases of incompatible transfusions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.

Rhophylac is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Rhophylac® is a registered trademark of CSL Behring AG.
Other trademarks mentioned are the property of their respective owners.
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