Wacker Biotech is producing medac’s cancer medication using a new, efficient, recombinant process. Based on a production strain of Escherichia coli, the new WACKER process for Spectrila® utilizes proprietary technologies such as high-cell-density fermentation. The WACKER contribution to the Spectrila® drug substance approval covers biopharmaceutical process development in its entirety – from generating the cell line, to establishing and validating the analytical methods for process control and release of the bulk drug, to the final, validated, industrial-scale production process.
In addition to improvements such as a reduced aggregate content, Spectrila® is also hallmarked by more efficient production: up to now, processes for manufacturing L-asparaginase could only be carried out in fermentation plants having volumes of over 20,000 liters. The process that WACKER has developed, however, can be run in a 300 liters bioreactor, thus simplifying production and making it considerably easier on the environment, as it requires fewer resources and materials.
Close collaboration with medac resulted in a high-quality medication for clinical trials and now for supplying the market. The reliable, modern process provides an efficient, secure supply of medication for patients.
Acute lymphocytic leukemia is the most common form of leukemia in children. Upon administration, L-asparaginase breaks down asparagine in the blood to form aspartic acid, thereby eliminating the nutrient that leukemia cells need to survive. L-Asparaginase has been used successfully for treating leukemias since the 1970s, and, when combined with other medications, can achieve a cure rate of 90 percent in children.
“This approval represents an incredibly important validation of the Wacker Biotech team’s skill and expertise,” said Dr. Thomas Maier, managing director of Wacker Biotech. “We have shown that we have mastered the complex demands of developing and validating microbial manufacturing processes. Only a handful of manufacturing specialists in Europe can say that about themselves, and we have now joined their distinguished ranks. And, along with our customer medac, we are gratified to be able to help cure ALL.”
Adding to this is Nikolaus Graf Stolberg, managing director of medac, who notes, “Continuing to develop treatment options and securing a long-term supply of proven actives based on top-notch manufacturing processes is simply a given at medac. Improving the chances of a cure for cancer patients in general – and, in this case, for children with leukemia in particular – makes all of our intensive development work and high development effort worthwhile.”
Spectrila® is now the second Wacker Biotech product that has been approved for Europe. Commercial production of Reteplase began at the Halle site in 2012; Reteplase is the active ingredient in Rapilysin®, a therapeutic agent used for treating acute myocardial infarction. In 2010, Wacker Biotech invested a total of €18 million to modernize its GMP production facility in Jena and meet modern requirements of the European Medicines Agency and the US Food and Drug Administration.
About Wacker Biotech
Wacker Biotech GmbH is a full-service contract manufacturer of biopharmaceutical products based on microbial systems. The company’s services range from molecular biology, analytical services and process development through to the GMP-compliant manufacture of clinical test samples and pharmaceutical actives for the commercial market at the GMP-compliant production plants in Jena and Halle, Germany. Above all, Wacker Biotech offers proprietary technologies that satisfy market needs for cost-efficient production and maximum quality. Based in Jena and Halle, Wacker Biotech is a wholly-owned WACKER subsidiary.
For further details, visit the following website: www.wacker.com/biologics
medac GmbH is a pharmaceutical company based in Wedel, Germany, specializing in the treatment and diagnosis of hemato-oncological, urological and autoimmune disease. Medications made by medac help physicians and patients around the world manage acute and chronic illness. medac has been dedicated to uniting therapeutic and diagnostic agents under one roof since 1970.
Additional information is available online at www.medac.de