Customer orientation is of crucial importance for the Life Science business. With sophisticated end-to-end solutions, we offer biopharmaceutical companies worldwide comprehensive services along the entire value chain.
It’s a long way from discovery to the commercialization of a new drug. This applies particularly to the biopharmaceutical industry – after all, it’s concerned with providing products to help sick people. In other words, medicines whose benefit has to be significantly greater than any potential risk. Besides medicinal efficacy, the quality assurance of manufacturing processes is the prerequisite for obtaining regulatory approval to market new drugs. This includes validating and documenting processes and methods, as well as qualifying staff and having suitable facilities with high-quality installations and equipment. Through our Life Science business, we offer a broad range of innovative products, services and expertise that support customers in the biotech industry with their research, development and production activities. With an end-to-end portfolio of products and solutions that deepened with the Sigma-Aldrich acquisition, we can cover the full bioprocessing value chain.
“I’m very happy that we could partner with Merck KGaA, Darmstadt, Germany, at an early stage of our project. Aspects such as quality, cost and our timetable were decisive. This is helping us to move our project ahead.”
Representation of a monoclonal antibody.
And our holistic approach comprises more. “It is very important to us to have a precise understanding of our customers’ goals, wishes and ideas. We plan, test and implement every individual step in close exchange with them. As a strategic partner, we accompany our customers up to market success and beyond – that’s a win-win situation,” says Guillaume Plane. As Global Development and Marketing Manager based in Bordeaux, France, he often travels on business and always stays close to customers. Acticor Biotech is a good example: This biotech company based in Paris is developing an antithrombotic drug for the emergency treatment of ischemic stroke without risk of hemorrhage. It is estimated that every year 15 million people worldwide suffer a stroke. Systemic thrombolysis is mostly used to unclog the patient’s affected vessel as rapidly as possible. However, this therapy is associated with the risk of brain hemorrhage. Acticor Biotech aims to eliminate this risk with its new molecule. “I’m very happy that wecould partner with Merck KGaA, Darmstadt, Germany, at an early stage of our project. Aspects such as quality, cost and our timetable were decisive. This is helping us to move our project ahead,” says Gilles Avenard, CEO of Acticor Biotech.
“It’s a bit like a builder entrusting an experienced architect with his project – and we’re taking the role of the architect.”
Whether a start-up or an established biopharmaceutical company – we offer offers the Provantage® End-to-End Solution as a comprehensive suite of products and services. This enables biopharmaceutical companies to accelerate the progression of molecules through clinical development and towards commercialization. The turnkey package includes process development, GMP clinical manufacturing, facility design, equipment for plant production, equipment qualification and training, process scale-up and technology transfer as well as facility start-up services. “It’s a bit like a builder entrusting an experienced architect with his project – and we’re taking the role of the architect,” says Plane, explaining our company's approach. Y-mAbs Therapeutics, Inc., a U.S. company based in New York City, is also utilizing the advantages of Provantage® End-to-End in order to advance its monoclonal antibody in late-stage clinical development. “Through our agreement with Merck KGaA, Darmstadt, Germany, Y-mAbs is taking a major step towards our commitment of making these breakthrough pediatric treatments available to children with advanced and life-threatening cancers,” says Thomas Gad, founder and president of Y-mAbs. “We expect to take delivery of cGMP drug product for our planned clinical trials by the first half of 2017. We are committed to making this leading immunotherapy product available to patients with life-threatening diseases worldwide.”
M Lab™ Collaboration Center in Songdo, Korea.
It is especially important to us to improve access to high-quality medicines. This applies above all to emerging economies, whether in Africa, Asia or Latin America. Therefore, we support established biopharmaceutical companies that decentralize their production and have to quickly and efficiently build local production facilities. “With an end-to-end approach, we can facilitate and accelerate scaling and technical transfer of an entire process to a new location,” says Plane. Small biopharmaceutical companies in early-phase clinical development with limited resources and infrastructure benefit from our company as a partner with strong expertise and experience in the development of biologics processes and GMP clinical manufacturing to help them accelerate their early clinical development programs.
Process development unit at our Biodevelopment Center in Martillac, France.
Mobius® 2000L single-use bioreactor.
The new M Lab™ Collaboration Centers are another approach highlighting the customer orientation of our Life Science business. The ultramodern facilities are a relaunch of the global network of customer collaboration centers that have existed for over 20 years. The network includes sites in Brazil, China, France, India, Japan, Singapore, Korea, and the United States. M Lab™ Collaboration Centers address customers who do not outsource their process development but are looking for the technical experience and expertise of our scientists and technicians in finding solutions to the challenges of their individual biopharmaceutical processes. The M Lab™ Collaboration Centers provide a suitable environment for hands-on experiments and practical training. Customers can apply best practices and new methods to develop or optimize processes. and facilitate global technology transfer – from discovery to the commercialization of a new drug.
“Through our agreement with Merck KGaA, Darmstadt, Germany, Y-mAbs is taking a major step towards our commitment of making these breakthrough pediatric treatments available to children with advanced and life-threatening cancers.”