SP Scientific has announced a new hands-on training course entitled 'Rapid and Rational Development of Stable Lyophilized Protein Formulations'.
Due to take place from September 17-20, 2013 the extended training course has been designed by renowned industry experts Dr Jeff Schwegman and Dr John Carpenter to provide valuable assistance to those involved in the development and manufacture of diagnostics, vaccines, and biologically based injectable drug products including monoclonal antibodies.
Today an increasing number of products being developed as vaccines, diagnostics, and injectable drugs are based upon biological molecules such asproteins, enzymes, and antibodies.
Companies involved in these markets use these molecules to develop testing kits to detect various disease states and their pre-cursers, to develop vaccines to prevent and or minimize infections and to develop protein based drugs, including monoclonal antibodies, to treat disease states in both humans and animals.
While discovery and development of these types of products has soared, traditional downstream development methodologies used in formulation and stabilization are often failing to achieve long term stability, consequently companies may find themselves unable to manufacture their products to meet the guidelines laid out by the FDA.
Lyophilization, or freeze-drying, is recognized as a process used to enhance the stability of many products; however, if not done properly on biologically based formulations, it can be extremely damaging to the physical structure of the molecule, rendering them inactive, aggregated, and potentially eliciting an immune response in patients.
Addressing this issue, the 4-day training course has been designed to enable people involved with lyophilization, at all levels of experience, to gain considerable knowledge about the rapid and rational development of stable lyophilized protein formulations and to reinforce their classroom training with extensive laboratory work.
Full details of this extensive hands-on training course to be held in SP Scientific's modern Warminster, PA laboratory / training facility is available at www.spscientific.com/ProteinHandsOn.