HAMBURG, Germany, May 6, 2021 / B3C newswire / – Richter-Helm BioLogics GmbH & Co. KG, a leading German-based, cGMP-compliant biopharmaceutical contract development and manufacturing organization (CDMO), today announced the start of construction of an expansion project at its cGMP manufacturing facility in Bovenau, Germany. The new multi-product organic manufacturing facility is expected to begin large-scale operations and manufacturing by the end of 2023.
âThe pharmaceutical biotechnology market has grown steadily and further growth is expected. In order to meet the demand for high-value biopharmaceuticals, Richter-Helm recently began expanding its microbial manufacturing capacity and continues to push its overall growth strategy. “ said Dr Kai Pohlmeyer, Managing Director of Richter-Helm. The basic engineering of the new facility has been completed and the groundbreaking ceremony was held on May 5, 2021 by the Richter-Helm management team, who initiated construction of the new facility.
Richter-Helm and its parent companies Gedeon Richter and HELM AG will invest nearly â¬ 70 million to triple current production capacity and expand its existing warehouse, laboratory and administrative buildings.
Currently, Richter-Helm operates two GMP compliant production facilities located in Hanover and Bovenau, Germany, with bioreactor capacities of up to 1,500 liters. The Bovenau expansion includes the installation of two additional highly flexible and fully equipped production trains with interchangeable product flows. Bioreactor capacities of 300 liters and 1,500 liters will be added. The production site will reach a total area of ââaround 10,000 mÂ² and will include all the necessary services and infrastructure, such as quality control laboratories, warehouse and technical areas.
Dr Kai Pohlmeyer further explains: âWith the addition of two new manufacturing trains, Richter-Helm is meeting the demands of its existing customers and the needs of the growing biopharmaceutical market. We will be more flexible and efficient in bringing the products of our global pharmaceutical customers to market. We also plan to create a significant number of new jobs for qualified professionals once the plant is fully operational â.
About Richter-Helm BioLogics
Richter-Helm is a leading cGMP contract development and manufacturing organization based in Germany, headquartered in Hamburg, Germany. Over the past 30 years, Richter-Helm has gained substantial experience in the development and manufacture of different classes of products, for example, recombinant proteins, antibodies, plasmid DNA (pDNA) and vaccines. The company currently operates one development facility and two cGMP manufacturing facilities for microbial production. Richter-Helm provides highly specialized contract development and manufacturing services to support the global pharmaceutical and biotechnology industries in strain development, process development, and the supply of products for clinical trials and commercial materials. Due to the close collaboration with its parent company Gedeon Richter, Richter-Helm also offers services in the areas of the production of mammalian cell-based drug substances and Fill & Finish solutions. For more information visit www.richter-helm.eu or connect with Richter-Helm via LinkedIn.
Richter-Helm BioLogics forward-looking statements
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 considered forward-looking statements, including estimates of income, operating margins, capital expenses, cash, other financial information. , expected legal, policy, regulatory or clinical outcomes and other estimates and outcomes. By their nature, these forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially from those that may be suggested by these forward-looking statements contained. in this press release. Important factors that could cause such differences include: changes in general economic, business and competitive conditions, inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the outlook of products in the pipeline or under development by Richter-Helm, effects of future court decisions or government investigations, product liability claims, challenges to patent protection of product or product candidates, changes in laws or regulations, fluctuations in exchange rates, changes or uncertainties in laws tax or the administration of these laws and the hiring and retention of its employees. Further, the information contained in this document does not constitute an offer to sell or the solicitation of an offer to buy securities, nor any offer, solicitation or sale of securities in any jurisdiction in which such an offer, solicitation or sale would be illegal prior to registration or qualification under the securities laws of that jurisdiction. Richter-Helm provides this information as of the date of this document and expressly disclaims any obligation to update the information contained in this press release, either to confirm actual results or to signal a change in expectations. There is no guarantee that new product candidates under development will progress towards product approval or that new indications for existing products will be developed and approved. Products or potential products that are the subject of partnerships, joint ventures or licensed collaborations may be subject to differences between partners. Too, Richter-Helm or others might discover safety, side effects, or manufacturing issues with its products after they are marketed.
In addition, sales may be affected by international and national trends towards containment of care and containment of healthcare costs and reimbursement policies imposed by third-party payers as well as legislation affecting prices and reimbursement of healthcare professionals. biopharmaceuticals.
Dr Kai Pohlmeyer
+ 49-40-55 290-430
Keywords: cell line; Cells, cultured; development of cell lines; Organic Products; Recombinant proteins; productivity; Manufacturing and industrial facilities; Germany
Posted by B3C newswire