PRESS RELEASE

Biotest receives manufacturing license for new production facility and plans to hire 150 additional employees

- Final inspection by the Darmstadt Regional Council and the Paul Ehrlich Institute successfully completed

- Start of routine production and ramp-up of the plants is initiated

- 150 additional employees are sought

Dreieich, 13 July 2021. 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 our 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.

"It makes us all very happy and proud after this long project period to have now mastered all approval inspections of our state-of-the-art production facility by the responsible supervisory authority in such an extremely successful manner. This was only possible due to the combined efforts of all involved disciplines, who have thus laid the foundation for the production of our new generation of immunoglobulins," said Peter Seith, Head of Quality Operations at Biotest AG.

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.

About Biotest Next Level (BNL)
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.

About IgG Next Generation
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.

About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: 06
Mail:

PR contact
Dirk Neumüller
Phone: 9
Mail:

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany,

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.