Definition and types of contract manufacturing organizations in biopharma
Contract manufacturing is the production of goods by a company for another company. Companies outsource manufacturing services to external companies with the required equipment, facilities, expertise, and/or bandwidth to generate a specific amount of a customized product.
Within the pharmaceutical industry, contract manufacturing organizations (CMOs) — sometimes referred to as contract development and manufacturing organizations (CDMOs) are organizations that pharmaceutical, biopharmaceutical, and biotechnology companies can partner with to move medical innovations from research and development to market.
CMOs manufacturing therapeutics are generally classified as pharmaceutical or biopharmaceutical based on the method of production. Pharmaceuticals are manufactured through a series of chemical syntheses, whereas biopharmaceuticals are manufactured in living organisms (e.g. bacteria, mammalian cells, etc.). Some CMOs are capable of manufacturing both pharmaceuticals and biopharmaceuticals.
Areas of expertise in biopharma contract manufacturing organizations
CMOs can be experts in specific areas, offering services for a particular industry niche, or can have wide-ranging capabilities enabling development and manufacturing services. Selecting the appropriate partner depends on the specific needs and product pipeline of the (bio)pharmaceutical company. Below are some areas of expertise of CMOs.
- Aseptic Fill/Finish – A process where the drug product, container, and closure are sterilized separately and then combined.
- Injectables – A drug delivery system where injectables are rapidly inserted into the body using a syringe, bypassing primary metabolism.
- Pre-filled syringes – An approach that minimizes drug waste, increases product life span and enhances level of market share. They are recognized as an efficient, reliable and convenient method for drug administration and make self-administration easier, which could boost compliance.
- High potency API – Pharmacologically-active ingredient or intermediate with high sensitivity that are effective at a much smaller dosage than traditional APIs. The potency can present specific handling challenges.
- Vaccines – Drug class that contains an agent resembling a disease-causing microorganism, which is usually weakened or killed forms of the microbe, its toxins, or a surface proteins
- Small molecules – Well-defined chemical compounds manufactured through chemical synthesis.
- Antibodies – Therapeutic antibodies can activate, repress, or alter immune responses to specific cells or molecules. The manufacturing process can involve in vitro or in vivo processes depending on certain factors such as scale, cost, and molecular features.
- Antibody drug conjugates – Complex molecules combining the customized targeting capabilities of monoclonal antibodies with cytotoxicity of certain drugs to discrimination between healthy and diseased tissue and kill diseased/compromised cells.
- Gene Therapy – Gene-modifying molecules, often packaged in viral vectors, that repair or replace cellular/tissue damage.
Some services offered by biopharmaceutical contract manufacturing organizations
Research and development
Research and development starts after a candidate drug is discovered and is the initial phase of the product life cycle. It includes numerous rigorous experiments, including protocol establishment and optimizations (i.e. cell line development), preclinical research, and clinical trials to assess therapeutic potential.
Drug Substance Production
Once a drug is deemed a suitable therapeutic, establishing a commercial manufacturing process capable of consistently producing a drug substance of the intended quality is critical to meeting demand, saving time, and mitigating costly delays and bottlenecks. Activities can include drug substance characterization, solid state research, process development, analytical development, quality control, stability studies, and manufacturing. Ultimately, the CMO is determining the best possible synthesis or production route for the target product to support the entire workflow required to make the product available for clinical studies and market authorization.
Formulated Drug Production
Proper formulations can determine intellectual property potential, lifecycle, and the success of a pharmaceutical product. Formulated drug production is a process that combines different chemical substances, including the active drug, to produce the final medicinal product. This involves dosage form development, dosage form production, packaging, and logistics.
Analytical Support
CMOs often offer a full suite of analytical services throughout research, development, and manufacturing phases to deliver high quality products and comply with regulatory guidelines. Some analytical support offered include methods development and validation, stability studies, raw materials and trace metals assessment, and microbiology/contamination evaluation.
Regulatory Support
Many CMOs minimize regulatory burdens for pharmaceutical companies by offering regulatory support. This can include navigating the regulatory landscape, filing for investigational new drugs and new drug applications, ensuring proper market authorizations, and maintaining up-to-date knowledge on guidelines relevant to the industry and specific product. Several CMOs offer support throughout the entire process from discovery through commercialization, which helps de-risk projects and streamlines go-to-market strategies.
Five Examples of Biopharmaceutical Contract Manufacturing Organizations
- Grifols International
A pharmaceutical and biopharmaceutical CMO with 15 state-of-the-art manufacturing plants, subsidiaries in 30 countries and regions, and commercial operations in over 100 countries. It offers research & development, drug substance production, and formulated drug production services for injectables, parenterals (large and small volume), and proteins. It has particular expertise in plasma-derived medicines and diagnostics. Grifols is recognized for accessible senior management, innovation, state-of-the-art facilities, and scientific competency.
- FujiFilm Diosynth Biotechnologies
A biopharmaceutical CDMO with expertise in cell culture, microbial fermentation, and gene therapy. It offers quality control, analysis and testing required to support the release of the drug substance, drug product, placebo and stability studies. It provides process development and manufacturing at four locations in the USA, UK and Denmark.
- Millipore Sigma
A biopharmaceutical CDMO offering cell line development, process development, manufacturing, scale up, analytical services, and regulatory support for biologics. It has 60 state-of-the-art manufacturing sites worldwide.
- Samsung Biologics
A biopharmaceutical contract development, manufacturing and research organization located in Incheon, South Korea with the largest biomanufacturing capacity (364 KL) at a single site. It offers research and development, drug substance production, formulated drug production, analytical support, and regulatory support. It is recognized for quality, compatibility, service, and speed in getting your drug to market faster and better. Upon completion of construction, the company’s fourth plant will be the world’s largest and most innovative manufacturing facility in the world.
- Wuxi Biologics
A China-based biopharmaceutical CDMO offering research and development, drug substance production, and formulated drug production for wide-ranging capabilities such as high potency compounds, antibody drug conjugates, and fusion proteins. It is recognized for compatibility, expertise, quality, reliability, and service and has partnered worldwide with 16 of the 20 largest pharmaceutical organizations.
With drugs becoming more complex and diverse, pharmaceutical companies need to be innovative and increase speed to market to remain competitive and boost returns on investment. Companies partnering with CMOs/CDMOs gain access to facilities and expertise required to move pharmaceutical innovations from discovery to market. With the ideal CMO partner, companies can save time, de-risk projects and avoid hefty upfront equipment and operational costs.