German CDMO Richter-Helm Triples cGMP Production Capacity to Accommodate Global Market Demand

Richter-Helm announced today the start of construction for an expansion project at its cGMP manufacturing facility in Bovenau, Germany. The new multi-product biological manufacturing facility is expected to begin full-scale operations and manufacturing by the end of 2023.

“The market for pharmaceutical biotechnology has been continuously growing and further growth is expected. In order to accommodate demand for high value biopharmaceutical products, Richter-Helm recently started expansion of its microbial manufacturing capacity and continues to push its overall growth strategy.” said Dr. Kai Pohlmeyer, Managing Director at Richter-Helm. The basic engineering of the new facility has been completed and the ground-breaking ceremony took place on May 5th, 2021 by the management team of Richter-Helm, who initiated construction of the new facility.
Richter-Helm and its mother companies Gedeon Richter and HELM AG will invest close to 70 million € to triple the current production capacity and expand its existing warehouse, laboratory, and administration buildings.

Currently, Richter-Helm operates two cGMP-compliant production facilities located in Hannover and Bovenau, Germany, with bioreactor capacities of up to 1,500 litres. The Bovenau expansion covers installment of two additional highly flexible and fully equipped production trains with interchangeable product flows. Bioreactor capacities of 300 litres and 1,500 litres will be added. The production site will reach a total area of about 10,000 m² and includes all necessary utilities and infrastructure, like QC-labs, warehouse and technical areas.

Dr. Kai Pohlmeyer further explains: “With the addition of two new manufacturing trains, Richter-Helm is supporting the demand of its existing customers and the needs of the growing biopharmaceutical market. We will be more flexible and more efficient in bringing products of our worldwide pharmaceutical clients to market. We also expect to create a significant number of new jobs for qualified professionals once the plant becomes fully operational“.

About Richter-Helm BioLogics

Richter-Helm is a leading Germany-based contract development and cGMP manufacturing organization with its headquarters based in Hamburg, Germany. Over the past 30 years Richter-Helm gained substantial experience in the development and manufacture of different product classes e.g. recombinant proteins, antibodies, plasmid DNA (pDNA) and vaccines. The company currently operates a development facility and two cGMP manufacturing facilities for microbial production. Richter-Helm offers highly specialized contract development and manufacturing services to support the global pharmaceutical and biotechnological industries with strain development, process development and supply of products for clinical trials and commercial material. Due to the close cooperation with its mother company Gedeon Richter, Richter-Helm also offers services in the areas of mammalian cell-based Drug Substance production and Fill & Finish solutions. For more information visit www.richter-helm.eu or connect with Richter-Helm via LinkedIn.

Forward looking statements Richter-Helm BioLogics

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by Richter-Helm, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. Richter-Helm is providing this information as of the date of this document and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, Richter-Helm or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

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