CMC Biologics is a world leading biologics Contract Manufacturing Organization (CMO), with commercial and clinical manufacturing of biopharmaceuticals at facilities in Europe and the USA
As the largest independent CMO in the world, CMC Biologics owes its leadership position to its constant focus over the past 13 years to technical excellence in all that we do and devotion to customer satisfaction. These two critical attributes go hand in hand and have driven the strong growth of CMC Biologics’ business. With over 400 employees globally, we are poised to further expand our global customer base, and to continue to offer standards of technical excellence and customer care that are unmatched by our competitors.
Første Spadestik! (Laying the Foundation)
CMC Biologics A/S was founded in 2001 in Copenhagen, Denmark to provide faster and more effective solutions to the biopharmaceutical industry’s growing need for outsourced development and manufacturing resources. The founding partners are shown below signing for their first 20 million DKK, needed to break ground and build CMC Biologics to the largest independent biologics manufacturing company in the world. Shown below are Founders Lars Hallgren, Anders Vintner, Mads Laustsen, Peter Vilby, Jens Gram and Morten Munk.
CMC BIOLOGICS TECHNICAL OFFERING: DEPTH AND BREADTH
From cell line development to commercial manufacturing, we make our clients’ priorities our own – CMC Biologics offers an extraordinary depth and breadth of scientific expertise. Over the years CMC Biologics has worked on numerous projects, together with delighted customers worldwide. Our development experience covers development of cell lines, API production processes, analytical methods and product formulations. Our manufacturing facilities extend from clinical development scale through to commercial cGMP manufacturing for mammalian and microbial based processes.
Our expertise ranges from monoclonal antibody production to the commercial production of complex proteins and challenging biopharmaceuticals. Our knowledge is a powerful asset that allows our Customers to achieve manufacturing objectives for purity, potency, and critical product attributes on time, at the scale required, and in compliance with FDA, EMA, and ICH guidelines. From early stages of development to commercialization of product, we provide solutions that will support commercial cGMP manufacturing and have the capabilities to meet our Customers’ commercial needs.
CMC Biologics’ integrated approach shortens biopharmaceutical development cycle time and accelerates manufacturing timelines – As part of our commitment to excellence in customer service, CMC Biologics has for many years focused on developing first class project management systems. Our experience and capabilities are seamlessly integrated, allowing for rapid and effective communication across project teams and providing a single interface for our clients’ contract biomanufacturing needs. The rapid flow of information reduces cycle time, supports rapid optimization of the manufacturing process, and ensures the development and deployment of appropriate and effective analytical tools.
Our global manufacturing facilities give our Customers the flexibility and quality standards to meet their needs – With clients in Europe, Australia, Japan, China, Israel, Canada, South America, and the United States; we have deep insight into the manufacturing requirements and standards of a broad array of regulatory agencies and certifying organizations. Our manufacturing facilities have been certified for Good Manufacturing Practice (cGMP) production of clinical and commercial manufacturing by the European Medicines Agency (EMA), and Danish Health and Medicines Authority (DHMA), and the US FDA.
CMC Biologics offers multiple cGMP manufacturing lines and a variety of scales for both mammalian cell culture and microbial fermentation. The design of our facilities allows for capacity and technological flexibility, including extensive adoption of single-use systems, while ensuring compliance with most current ICH guidelines required for cGMP production.
We provide solutions for a defined part of the expansive drug development and commercialization continuum, and we see ourselves as partners in our clients’ success to ultimately bring life-saving therapies to patients world-wide.
2000 Liter Single-Use Disposable Bioreactor 3000 Liter Stainless Steel Bioreactor