Hormones and Steroids
Steroids, endogenous hormones such as the sex hormones estrogen and testosterone or the hormones of the adrenal cortex, cortisol and aldosterone, play a key role in metabolic processes and have a number of pharmaceutical applications, including hormone therapy, anti-rheumatic, anti-arthritic and bodybuilding preparations.
Mainly used in the global hormone replacement therapy, currently worth about $3.6 billion, the three major segments comprise estrogen, growth and thyroid hormone, and testosterone replacement therapy. A major market driver is the increased awareness of postmenopausal hazards amongst women; others include an ageing population, innovative drug delivery systems and the pharmerging economies.
Predominantly based on cholesterol, steroid hormones are synthesized in the endocrine glands and transported to target tissue by the blood. At their site of action, they dock with highly specific cellular receptors and perform a key function in protein formation. To produce steroid hormones for pharmaceutical applications outside the body, a direct extraction procedure from special nutrient solutions is used.
Counter-Current Liquid-Liquid Extraction
In continuous direct extraction from GEA, the fermented nutrient solution is treated by liquid-liquid extraction in a counter-current process. Following precipitation, concentration, crystallization and drying of the extract, the steroid hormones are available in the form of a raw salt and can be correspondingly processed by the pharmaceutical industry. In a continuous direct extraction process, the fermented nutrient solution undergoes a counter-current liquid-liquid extraction process (also known as also known as solvent extraction or partitioning). Following precipitation, concentration, crystallization and drying, the extracted steroid hormones are available in the form of a raw salt and can be subsequently processed by the pharmaceutical industry.
From facility design and layout, manufacturing process controls (including adherence to standard operating procedures) and environmental control systems (HVAC) to extraction systems, industrial hygiene solutions and fully integrated, end-to-end containment solutions, GEA has the experience and know-how to implement and optimize end-to-end production lines for steroid- and hormone-based applications.