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What is a Contract Manufacturing Organization?

In recent decades, the pharmaceutical industry has witnessed the rise of the contract manufacturing organization (CMO), a company that works with developers of pharmaceuticals to design and manufacture their drugs. Using the services of a CMO enables pharmaceutical companies to outsource non-strategic aspects of their business and focus on value-added functions such as discovering and marketing drugs.

CMOs often offer drug development services as well as manufacturing assistance to provide pharmaceutical companies with a comprehensive set of options. Included among the services these organizations offer are:

Commercial production
Conduct and plan clinical trials
Drug development
Formal stability
Formulation development
Method development
Pre-formulation
Registration batches

The market for the services provided by contract manufacturing organizations has grown in response to increased competition in the pharmaceutical market and avid demand for new products. To speed up time to market, pharma companies can take advantage of the pre-existing capacity and expertise found in CMOs. Additionally, using the services of a CMO can help reduce costs both from the perspective of saving equipment purchase expenditures, but also in employee compensation that would otherwise be expended to hire or train employees with the necessary expertise to perform such services.

The CMO market has grown substantially, with one study estimating it will total $188.07 billion by 2026, growing at a rate of 9.4% between 2019 and 2026. This growth is partly driven by increased costs for pharmaceuticals along with the demand for comprehensive drug development and manufacturing services by drug companies.

What are some top Contract Manufacturing Organizations?

The top CMOs typically offer their customers a wide variety of services designed to help shepherd medicines through all stages of the drug development process, from conception to commercialization. In addition to manufacturing, this often involves development processes such as initial proof of concept and viability testing.

Here are four top contract manufacturing organizations:

Samsung Biologics

With the largest capacity at a single site and the fastest throughput of any CMO, Samsung Biologics is well positioned to provide its customers with comprehensive services covering all aspects of the biopharmaceutical product development life cycle. This includes:

Development
Manufacturing
Laboratory testing services

Samsung Biologics emphasizes process innovation to make sure it delivers the highest quality manufacturing practices in conjunction with client-centric innovation. The company’s execution excellence is enabled by its agility, adaptability, and rapid response to changing business conditions. These traits allow the company to provide cost competitiveness for the benefit of its customers and for patients via access to life-saving medicines.

Portfolio innovation is another area of emphasis for the company, enabling it to continuously expand its business scope and the services it offers beyond CMO to also include CDO and CRO. Samsung Biologics offers global reach and integrated end-to-end services through its diversified business portfolio. The company works with its customers to provide seamless tech transfers, clinical and commercial manufacturing, aseptic fill/finish, and analytical testing.

Boehringer Ingelheim

Boehringer Ingelheim strives to serve mankind through its actions to improve the health of both humans and animals. It is a global group of family-owned companies that has grown from the pharmaceutical company founded by Albert Boehringer in 1885. The company focuses its pharmaceutical development activity primarily in the areas of cardiovascular diseases, respiratory diseases, metabolic diseases, diseases of the central nervous system, and oncology.

Boehringer Ingelheim BioXcellence is the group’s biopharmaceutical contract manufacturing unit. The division provides tailor-made contract development and manufacturing services to the industry by offering the complete production technology chain from DNA to fill and finish in a single location, making outsourcing easy. The company uses its innovative technologies and dedicated staff to provide process development assistance.

Almac

Almac is a world-leading contract pharmaceutical development and manufacturing company that helps companies navigate the complete biopharmaceutical lifecycle, starting at drug development and leading to commercialization. The company has numerous facilities spread across Europe, North America, and Asia from which it offers expert pharmaceutical drug product development solutions. Almac’s facilities are state-of-the-art, featuring custom designs to help the company’s scientists optimally develop its customers’ formulations as well as manufacture solid oral dose products through all clinical trial stages.

Almac has boosted its ability to offer pharmaceutical drug product development services by purchasing two connected facilities inside the Charnwood Campus in Loughborough, United Kingdom. The purpose-built facilities significantly increase the company’s capabilities in solid oral dose drug product development, manufacturing, and analytical testing. Almac reports that its Almac Clinical Services unit currently provides its services to more than 600 pharmaceutical and biotech companies globally.

Vetter

Vetter, with 5,000 employees worldwide, serves as a global CDMO (contract development and manufacturing organization) focusing on aseptic processes. The company specializes in producing aseptically prefilled syringe systems, cartridges, and vials. The company does not manufacture its own drugs. 80% of its products are biologics.

Vetter helps guide biopharmaceutical companies and their products through the drug development process from preclinical through phase III. The company stands ready to provide clinical fill and finish for various batch sizes and injections systems, including vials, syringes, and cartridges. Vetter has significant experience and expertise in: