At the beginning of July 2021, the approval of the production facilities of the Biotest Next Level (BNL) expansion project was successfully carried out by the Darmstadt Regional Council and the Paul Ehrlich Institute and, as a result, the manufacturing license was granted in accordance with ?13 AMG. The manufacturing of the products can thus begin in the new production facilities. The final steps for the market approval of new IgG Next Generation immunoglobulin still need to be completed. At the beginning of 2022, Biotest will apply for approval at the Paul Ehrlich Institute with the data of the first, currently produced batches and subsequently ramp up production in parallel. Biotest is looking for 150 additional employees for the start-up and operation of the new facility at the Dreieich site. The majority of the vacancies will be in the occupational groups of chemist and pharmacist for the production of IgG Next Generation. In addition, Biotest is also looking for laboratory assistants, scientists and engineers for the areas of production, quality control, quality assurance and technology. The increase in personnel is expected to more than double Biotest's production volume to approximately 3 million litres of blood plasma over the coming years. With the investment programme "Biotest Next Level", Biotest will more than double the total production capacity of the Biotest Group. In addition to the construction of a plasma base fractionation plant with a throughput of 1.4 million litres, bulk production facilities will be built for albumin as well as for the new product lines Fibrinogen and IgM Concentrate as well as the next generation polyvalent immunoglobulin G. IgG Next Generation (BT595) is a human normal immunoglobulin (100 g/l) preparation for intravenous administration. It will be used for patients with antibody deficiency and autoimmune diseases (e.g. PID, ITP, Kawasaki syndrome, selected neuropathies). The product will be the lead product of the Biotest Next Level production expansion.