Dipl.-Ing. Michael Andesner

Process- and product development of plasma derived cytokines including purification of the API, design and pharmazeutical composition of the product. Development of analytical methods to characterize the product. Supervision of laboratory staff and cost control of the development project.

Development of production processes for biopharmaceuticals including formulation development. Development of analytical methods for product characterization. Development of methods to characterize protein aggregates. Pharmazeuticals in wound healing involving growth factors. Medical devices class 3.

Product & Process Expert (Fibrin Sealant); Responsible for the performance of production processes, deviation and change control evaluation as well as technical problem solving. Downscale of process steps to investigate production problems. Support of regulatory affairs in product licensing. Development and characterization of filtration processes involving micro- and ultrafiltration methods.

Process Improvement and Assurance: Improvement and control of manufacturing processes for biopharmaceuticals (Fibrin Sealant); Downscale of production process steps for problem investigation studies. Development of process steps for the purification of proteins involving chromatographic separation methods and protein precipitation. Transfer of processes to production departments. Involved in the production of clinical batches.