From drug development to marketing authorization, Valicare supports chemical, pharmaceuticals and biotechnology companies around the globe.
In the GMP-regulated industry, regulatory requirements for pharmaceuticals companies are constantly increasing – and so is the demand for consulting services. Dr. Berthold Düthorn recognized this need early on and founded Valicare GmbH in 2002.
The company laid the foundation for its success at its headquarters in Frankfurt am Main with the risk-based qualification of new plants for the aseptic filling of pharmaceuticals. Today, Valicare offers a diverse portfolio: as a service provider for GMP compliance, the company qualifies technical equipment, utilities and clean rooms from a wide range of pharmaceuticals sectors, while also validating manufacturing processes, cleaning processes, analytical methods and, last but not least, computer/IT systems for pharma and biotech customers. In addition, Valicare provides support in the manufacture of advanced therapy medicinal products (ATMPs) and in the medical device industry. With great success: the company has implemented over 2,000 GMP (“Good Manufacturing Practice”) projects to date.
At the Valicare anniversary celebration, Dr. B. Düthorn, founder of Valicare GmbH, gives a review and outlook of the company.
Together with its sister company Valicare s.r.o., a joint venture between Valicare GmbH and Heitec AG founded in 2006 in Turná near Trenčín (Slovakia), Valicare is home to more than 70 engineers and 30 natural scientists and has been ISO 9001 certified since 2011. Its staff provide risk-based qualification and validation for plants and processes as well as comprehensive auditing and inspections services. “Thanks to our interdisciplinary expertise and years of experience, we can provide pharmaceuticals companies with the best possible support in designing and implementing GMP- and ISO-compliant systems and processes,” emphasizes Dr. Hans-Georg Eckert, site manager in Frankfurt. A pharmaceuticals laboratory founded two years ago in Turná offers further expertise: the facility, which Valicare uses for the testing of biological indicators, among other things, meets the requirements of GMP and GLP (Good laboratory practice) and is in accordance with the ISO 14644 cleanroom standard.
GMP for ATMPs: Valicare’s key role for the future
Valicare’s GMP expertise is urgently needed: the production of novel and personalized medicinal products (ATMPs) such as cell and gene therapies, but also of tissue engineered products is subject to special regulations. In order to bring these drugs to market quickly and safely, manufacturers often require GMP consulting at the highest level.
Accordingly, for the past several years the team has been assisting ATMP developers who are seeking to transition from drug development to GMP-compliant manufacturing and ultimately to marketed products. “Transferring methods developed in the laboratory to a GMP-compliant manufacturing process requires a high degree of standardization. Start-ups in particular, but also medium-sized companies, benefit from our many years of experience,” says Dr. Hans-Georg Eckert. Valicare has thus once again significantly expanded its approach to supporting these products throughout their entire lifecycle – and is confident about the future. “We now have so much expertise in the ATMP business that we would like to establish ourselves as the market leader in this area,” says Eckert.
First, however, the company will duly celebrate its anniversary together with customers and colleagues!
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