A1M Pharma manufactured candidate drug ROSgardTM ­ based on a recombinant version of the endogenous protein A1M ­ in compliance with applicable GMP requirements. The product is approved and released by the company and the next step before clinical studies is the Fill & Finish process conducted by CordenPharma. Securing a large-scale manufacturing process in compliance with GMP is a prerequisite for clinical studies and the manufacturing of ROSgardTM for commercial use. According to the regulatory requirements, manufacturing and control of the candidate drug must be in compliance with Good Manufacturing Practice (GMP) for the product to be used in humans. Since the last large-scale manufacturing of the active substance in the candidate drug ­ which was conducted for the GLP toxicology studies ­ selected stages in the manufacturing process have been optimized to increase the yield of the active substance in ROSgardTM. The result shows that the candidate drug ROSgardTM has a high level of purity and meets the requirements for use in humans.