Since more than 20 years Heraeus is known to be an expert for the synthesis of platinum based anti-cancer APIs. Coming from platinum chemistry and precious metal refining we have an excellent basis for this business.
Precious metal based APIs, such as Cisplatin, Carboplatin, Oxaliplatin and others were the launching pad to extend our activities to further, non-precious metal based substances – such as, e.g., Dacarbazine, Thiotepa. This step into organic chemistry was made about 6 years ago and was accompanied by the broadening of our technical capabilities and capacities.
Today Heraeus is a specialist for highly potent APIs (HAPIs) with extraordinary claims for product, staff and environmental protection. We are focused on small volume HAPIs which are difficult to develop, to produce and to handle.
After adding the organic chemistry to our portfolio now we are ready to meet the next challenge:
There is a remarkable demand for substances which cannot be economically produced by chemical synthesis only. As competitive pricing is a key to the success of novel and generic drugs, for these kind of products a broad application is closely linked to more efficient manufacturing techniques.
For that reason Heraeus is on its way to install fermentation capacities for HAPIs at its new facility in Hanau. Together with downstream chemical processes this state-of-the-art equipment will serve to produce selected HAPIs in superior quality with an excellent impurity profile and attractive cost structures.
The commercial fermentation unit and a dedicated biochemistry lab will be installed during 2005. Our first substances in this area will be Epirubicin and Idarubicin, surely followed by additional products in the near future.
The equipment will be operated under cGMP, and we will apply for approval of the manufactured HAPIs by the FDA, the European and other authorities.
Beside the new type of equipment a crucial factor in this project is the adoption of know-how at our Business Unit Pharma: the handling of gene modified bacteria strains which have to be regarded as the basis of highly economic and efficient processes.
Although it may surprise that “Heraeus goes fermentation” we consider this as another milestone in our main objective to develop, produce and market small-volume HAPIs in superior quality together with an excellent service. Thus we will broaden our portfolio with very interesting products, future orientated technology and make completely new technical options available to our customers.
Successfull GMP-Audit by German authorities
We are pleased to inform you about a successful GMP-Audit conducted by the responsible German authorities
at the Heraeus site in Hanau on March 25/26, 2004.
This audit covered our API manufacturing facilities QA/QC as well as documentation regarding Cisplatin, Carboplatin,
Dacarbazine and Thiotepa.
GMP certificates are available on request, so please let us know in case we can be of any assistance.
Symposium on Cancer Therapy
Platinum compounds have been used in cancer therapy for more than 25 years. Scientists from around the world recently met in New York City for the 9th ISPCC conference (International Symposium on Platium Coordination Compounds in Cancer Chemotherapy) to discuss new developments in anti-tumor substances based on platinum. The symposium was supported by a number of companies that are active in this sector. One of the sponsors was the Pharma business unit of W.C. Heraeus, which produces active pharmaceutical ingredients for cancer treatment.
“Most people aren´t even aware of the elementary role that platinum components have played for the past 25 years in the treatment of a wide variety of different cancers”, said Dr, Holger Rauter, Development Manager of Business Unit Pharma.
The special focus of the conference was on the two most prominent plantium components of cancer treatment: Cisplatin and Carboplatin. “Cisplatin and Carboplatin have the ability to inhibit the division of living cancer cells as a consequence can largely prevent a dispersion of the cells”, explained Rauter.
By supporting an participating in the conference with a corporate presentation and a scientific poster, the Business Unit Pharma wants to make people more familiar with the name Heraeus in the area of institutional research as a service provider in the fields of API manufacturing, synthesis and development.