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CSL and its predecessor companies have pioneered innovation in anti-D Rh Immune Globulin for over 40 years.
Following the 1966 Congress of the ISBT (International Society Blood Transfusion), at which there was a roundtable held on The Prevention of Rh Haemolytic Disease, CSL Limited and the Australian Red Cross set up a program to collect anti-D plasma from donors with high-titre antibodies. They commenced distribution to mothers at risk the following year in 1967.
At about the same time, in Switzerland, ZLB (formerly the Swiss Red Cross Blood Transfusion Service) in Zürich commenced collection of plasma from Rh-immunized female patients. The plasma was sent to the German Red Cross Blood Transfusion Service in Baden-Baden, Germany, for manufacture.
This product was improved over the course of several versions of anti-D Rh Immune Globulin over the next 15 years including a 6% Ig IM/IV product in 1982.
This collective experience was the foundation from which Rhophylac® was conceptualized and created.
In 1991, investigators at what is now CSL Behring started doing research to develop an anti-D product of exceptional purity. The overall goal was to create an improved therapy for hemolytic disease of the newborn (HDN). Objectives were to find:
- The highest concentration of anti-D and the lowest levels of IgA and other unwanted proteins
- A liquid formulation suitable for both IM administration and IV delivery
- A thimerosal (mercury)-free, and latex-free formulation
Martin Stucki, a senior research scientist who had been studying plasma products for
20 years with the company, embraced this challenge. Stucki and one lab assistant began the project, but it soon grew into a companywide effort.
From the start, Stucki was convinced that the key was to replace the conventional fractionation process, which was currently the gold standard of the industry, with a radically new way to isolate anti-D from plasma. His highly specific three-step chromatographic process efficiently segments Rh proteins and removes undesirable components from plasma based on differences in the surface charge of the molecules.
The result was an innovative, patented manufacturing process (ChromaPlus), comprised of three complementary steps—S/D treatment, chromatography, and nanofiltration. ChromaPlus provided a product that met CSL Behring's goals and objectives-Rhophylac®.
Three years into the project, Stucki presented his work at a 1994 international conference, ultimately sparking worldwide demand for Rhophylac®. In 1996, Rhophylac® was introduced to the Swiss market and was the world's first liquid intravenous anti-D Rh Immune Globulin for the prevention of HDN. This was followed by its introduction in Germany in 2001 and in the US in 2004.
Rho(D) Immune Globulin at CSL Behring – Over 40 Years of Innovation
1967 |
ZLB is the first company in the world to supply Anti-D RhIg to mothers at risk in Switzerland |
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1967 |
CSL supplies Anti-D RhIg to mothers at risk in Australia |
1969 |
Ethanol fractionated; 16% Ig; IM only |
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1982 |
IM/IV version developed; improved product "Immunglobin Anti-D SRK;" ethanol fractionated; 6% Ig |
1996 |
Chromatographically purified Rhophylac® introduced in Europe; 0.5% Ig; IV and IM |
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2004 |
Rhophylac® is introduced in the United States |
View a timeline of RhIg innovation
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