Grifols Achieves Key Milestone with FDA Approval of the New Consolidated Manufacturing Facility (CMF) for Production of Recombinant Proteins
EMERYVILLE, Calif., Aug. 16, 2018
EMERYVILLE, Calif., Aug. 16, 2018 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a global healthcare company with a history of more than 75 years of improving people's health and well-being and a leader in the development of innovative diagnostic solutions, recently received approval from the U.S. Food & Drug Administration to relocate existing immunodiagnostic manufacturing operations to a new Consolidated Manufacturing Facility (CMF) in Emeryville, California.
This first submission enables commercial good manufacturing practices (GMP) Fermentation, Purification, and Bulk Fill operations in the facility and the production of one recombinant HCV antigen. Additional submissions to the FDA are planned to relocate the production of other licensed recombinant protein products. The transition is targeted for completion in mid-2019, pending the FDA approvals for the licensed antigens. Once the transition is complete, Grifols will have transferred 21 products to CMF.
"The FDA approval is a major milestone for this multi-year project," said Ramon Biosca, vice president and general manager of Grifols Diagnostic Solutions. "The new facility is a significant investment in our manufacturing organization and will ensure reliable, long-term production of current and future products."
As part of Grifols' investment for future growth, the company designed, built, and validated the $80 million, state-of-the-art, biological manufacturing facility in the San Francisco Bay Area. The new facility has 25,000 square feet of GMP manufacturing space, including two fermentation suites for E. coli and yeast processes, three purification suites, and a bulk fill area. Automation systems provide control of manufacturing processes and a central data historian monitors and stores all data generated in the facility, including the warehouse and utility systems.
In addition, Grifols has recently begun an engineering project to convert the 9,000 square foot expansion space within CMF into cell culture and purification suites for production of recombinant proteins expressed in mammalian cells. The facility will use disposable technology and is expected to be complete in late 2019.
The new Consolidated Manufacturing Facility, along with the development capabilities in the laboratories and pilot plant, provides a range of process scale and flexibility for the current portfolio of products and the R&D pipeline, as well as supports development and manufacturing services to third parties for recombinant protein production.
"The Emeryville campus has a long history of recombinant protein production, beginning with Chiron in the 1980s," said Biosca. "With this tradition of technical expertise and the new facility, Grifols is well equipped to provide contract development and manufacturing services to our current and future customers."
Grifols is a global healthcare company with more than 75 years of legacy dedicated to improving the health and well-being of people around the world. Grifols produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to help them deliver expert medical care.
Grifols' three main divisions – Bioscience, Diagnostic and Hospital – develop, produce and market innovative products and services that are available in more than 100 countries.
With a network of 225 plasma donation centers, Grifols is a leading producer of plasma-derived medicines used to treat rare, chronic and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of diagnostic products designed to support safety from donation through transfusion. The Hospital Division provides intravenous (IV) therapies, clinical nutrition products and hospital pharmacy systems, including systems that automate drug compounding and control drug inventory.
Grifols is headquartered in Barcelona, Spain and has 18,300 employees in 30 countries.
In 2017, sales exceeded 4,300 million euros. Grifols demonstrates its strong commitment to advancing healthcare by allocating a significant portion of its annual income to research, development and innovation.
The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex- 35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the US NASDAQ via ADRs (NASDAQ:GRFS).
The facts and figures contained in this report that do not refer to historical data are "future projections and assumptions". Words and expressions such as "believe", "hope", "anticipate", "predict", "expect", "intend", "should", "will seek to achieve", "it is estimated", "future" and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols Group.
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