Harlan Provides Expertise for Biologics & Biosimilars
Harlan Laboratories, Ltd. is prepared to meet the global demand for development programs in novel biologics and biosimilars. While the US FDA is slower to adopt regulations for biosimilars than the European Medicines Agency, Harlan CRS has already established regulatory expertise and offers non-human primate (NHP) toxicology services for preclinical and nonclinical programs to accommodate biologics and biosimilars development projects.
“Preclinical testing for small molecule pharmaceuticals is well understood, but the design of an appropriate biopharmaceutical preclinical and non-clinical development program and its successful evaluation by global regulatory authorities vary from case to case,” said Ciriaco Maraschiello, Director of Strategic Initiatives and Deputy General Manager of the Pharmaceutical Business Unit at Harlan CRS.
Biosimilars are subsequent versions of biopharmaceuticals with expired patents. Like biopharmaceuticals, biosimilars derive from various cellular systems, such as bacteria, yeast, insect, plant and mammalian cells, and their development is specifically regulated in the European Union. Unlike new chemical entities, which are metabolized in the body, biologics are catabolized. Thus, the selection of relevant species for preclinical development within the regulatory framework set by ICH S6(R1) depends on determining if the test material is pharmaco¬logically active in the selected species. The emergence of biologics offers new perspectives for the treatment of cancer and immune-system-related infections and diseases.
“Biologics and biosimilars represent a different paradigm for general toxicology compared to small molecules. Harlan CRS provides access to the highest scientific and technical standards avail¬able for their preclinical and nonclinical development, backed by significant regulatory expertise in this area,” Maraschiello said. “In addition, we link our capabilities and expertise in the general toxicology of biopharmaceuticals to our integrated drug discovery and translational medicine services to streamline the development of biologics and biosimilars.”
Harlan Laboratories, Ltd., a subsidiary of Harlan Laboratories, Inc., provides general and specialty toxicology services through its Contract Research Services business to the global chemical, agrochemical, and pharmaceutical industries. With laboratory locations in Germany, Spain, Switzerland, and the UK, Harlan and its affiliates are focused on providing customers with services to optimize product development. Please visit www.harlan.com/CRS.
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