What is a Contract Manufacturing Organization?
Contract manufacturing organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) are companies that provide services on a contract basis to partners in the pharmaceutical industry, which can range from developing to manufacturing drugs. They effectively allow pharmaceutical companies to outsource some of the biggest logistical challenges to specialists who are better qualified to handle them, allowing companies to scale their manufacturing operations while shifting focus to other aspects of the business, such as discovery or marketing.
Because a CDMO can also develop drugs, they offer a wider array of services than a typical outsourcing partner. A typical CDMO’s responsibilities include: preformulation and formulation development, method development, stability studies, pre-clinical trials, Phase I and late-stage clinical trials, scale-up of manufacturing operations, registration, and commercial drug production. They offer their services at market-rate prices while complying with the rules and regulations of a tightly controlled industry, following best practices as established by the Food and Drug Administration or its analogues in countries all over the globe.
Why work with a CMO?
When a biopharma company develops a new drug, failures can be financially devastating—and they aren’t uncommon. For example, when a product fails in late-stage trials or clinical research, partnering with a CMO limits the client’s risk.
However, choosing to work with a CMO can also result in the client having less direct control or oversight of a project. Cost overruns, quality issues, and accountability problems can come up throughout the working relationship. Businesses often have to exchange highly specialized intellectual property, which can lead to data security issues, and it takes an innovator in the field, like Samsung Biologics, which is ISO27001 certified, in order to allay these fears and ensure the safety of confidential, mission-critical data.
Throughout the drug manufacturing industry, CMOs can uniquely position themselves with a focus on particular technology, types of dosages, or features such as continuity or efficiency, in order to protect themselves from having to compete solely on the basis of price.
Over the last decade, CMOs have undergone a number of major acquisitions worth well over $20 billion in just 2017 alone, with companies getting access to proprietary technologies and supply chains once controlled by their now-partners. For example, Thermo Fisher Scientific merged with Patheon to enable the latter to provide one-stop, comprehensive services in clinical development, manufacturing, and packaging, and the Carlyle Group merged with AMRI Global to improve financial and operational performance.
The CMO market is expected to continue growing as a result of rising medicine costs, globalization, and powerful, fast-emerging new technology. Many drug manufacturers will be looking for specific capabilities, high quality service, transparency, and supply chain performance in choosing the CMOs that they want to work with.
Major CMOs to Know About
Launched in 2011 by the Samsung Group, Samsung Biologics is a CDMO with the ability to create monoclonal and recombinant drug products and substances on a flexible, cost-effective basis for a wide array of clients. The company provides a number of different services, including clinical and commercial bulk cGMP manufacture, analytics, fill finish services, and monoclonal and recombinant drug product creation.
Samsung Biologics currently employs over 2,600 people, has over 30 major international clients, and a manufacturing capacity of 364KL. The company has won CMO’s Leadership Award seven years in a row, and has a wide range of other achievements, including the aforementioned ISO27001 certification, which they were the first to acquire. In 2019, Samsung Biologics also scaled up their operations to allow them to complete N-1 perfusions for commercial applications and signed a third deal with UCB, giving them the opportunity to produce anti-tau candidates to treat progressive supranuclear palsy.
ProBioGen is a CMO that provides GMP production cell lines, process development, virus production development, GMP manufacturing, biosimilar and biobetters, analytics, and quality management services. Founded in 1994 as a spin off from one of Europe’s largest university hospitals and based in Berlin with over 150 employees, ProBioGen has access to 1,000L single-use bioreactor capacity with a second bioreactor to be brought online soon.
The company’s partners include Thermo Fisher Scientific, with whom they engineered the Freedom CHO-S Kit platform for cell line development, and Boehringer Ingelheim, which holds a non-exclusive license on ProBioGen’s GlymaxX ADCC enhancement technology for antibody production.
FUJIFILM Diosynth is a global CDMO partner offering complete solutions in pharmaceutical manufacturing, facilitating everything from pre-clinical investigation to commercial cGMP production. For over three decades, the company has provided clients with the support they need to develop and manufacture recombinant proteins, viral vaccines, and gene therapies.
FUJIFILM Diosynth has facilities located in College Station, Texas; Hillerød, Denmark; Research Triangle Park, North Caroline; and Teesside, UK, giving drug manufacturers access to over 50 bioreactors ranging between 3 and 200 liters in size. The company provides clients with a wide range of compounds, including monoclonal antibodies, recombinant proteins, vaccines, and gene therapy solutions for pharmaceutical clients.
WuXi Biologics is a China-based biologics firm founded in 2014. Spun off from WuXi AppTec, WuXi Biologics provides its clients with biologics discovery, development, and GMP manufacturing, and has built a number of major partnerships with clients in the pharma and biotech industries. Some of its featured platforms include custom protein generation, mammalian and microbial-derived products, antibody conjugates, and the WuxiBody bispecific AB platform.
In 2018, WuXi announced their intention to build a drug manufacturing facility in Dundalk, Ireland. This $394 million facility will be one of the largest single-use bioreactors in the world, and will have a major impact on development of biologics in Europe and the global supply chain.