Andre Germishuizen

Background

About Andre Germishuizen

Seasoned bioprocess engineer with more than 15 years of senior management experience in various aspects of the development, production and quality management of sterile injectable biopharmaceuticals to ensure cGMP compliance and optimal production output. I am currently overall responsible for all regulatory affairs, quality assurance and quality control functions, as well as production microbiology in the manufacturing of plasma derived medicinal products (PDMP's) such as IgG, albumin, Factor and FIX etc. Further, as a current Senior Manager and previously as COO at Deltamune I have extensive experience in the management of multidisciplinary teams to achieve effective development (including clinical evaluation), scale-up, process validation and routine production in the field of biopharmaceuticals. Specialties: Drug and vaccine development and clinical evaluation Biopharmaceuticals Pulmonary delivery Spray drying Polymer technology Pharmaceutical quality systems, including cGMP and GLP ISO13485:2016 for medical devices Sterile injectables Aseptic processing Regulatory and Clinical Affairs Quality Assurance, including incident investigation, CAPA, risk management, cGMP auditing, and validation Technology Transfer