Biopharmaceutical contract manufacturing is a service pharmaceutical and biopharmaceutical companies can outsource to contract manufacturing organizations (CMOs) — also referred to as contract development and manufacturing organizations (CDMOs) — to produce biologics and biosimilars. Unlike traditional pharmaceuticals such small molecules that are generally made using chemical synthesis, biopharmaceuticals are medicines made in living organisms such as mammalian cells or yeast. Biopharmaceuticals require specialized facilities, equipment, and expertise to efficiently produce high-quality products and biopharmaceutical contract manufacturing delivers these requirements, which can help de-risk projects by accelerating speed to market and reducing development and manufacturing costs.
Biopharmaceutical Contract Manufacturing Market
According to Research and Markets, the biopharmaceuticals contract manufacturing market was valued at roughly $13.7 billion in 2019 and is expected to reach almost $25.5 billion by 2027 based on growing at a CAGR of 8.2% from 2020 to 2027. The major market drivers include the increasing trend of pharmaceutical companies outsourcing development and manufacturing activities and the growing demand for biologics. The global market is segmented by products and services. The product segments include biologics and biosimilars, with biologics accounting for the largest market share in 2019, but biosimilars expected to grow at a faster rate.
Services are segmented into development process, final dosage operations, and final packaging. The development process held the largest share of the market in 2019, and analytical and quality control market segments are anticipated to grow the fastest.
Biomanufacturing Biologics and Biosimilars
Biologics are large, complex proteins made from living cells by using complex manufacturing processes. Examples of biologic drugs include vaccines, antibodies, blood, blood components, cells, allergens, genes, tissues, and recombinant proteins. A biosimilar is a copy of a biologic drug that is similar, but not identical, to the original medicine that can become available on the market after the patent for a previously authorized version has expired. For a biosimilar to be approved, it must be deemed “highly similar” to an approved biologic (i.e. reference product), in terms of structure, function, safety, purity, and potency, and sometimes efficacy. Additionally, biosimilars need to have comparable pharmacokinetic and pharmacodynamic properties to the reference product.
Biomanufacturing involves establishing a production cell line by genetically engineering a cell (i.e. production cell) to produce a specific protein. E. coli bacterial cells and Chinese hamster ovary cells (CHO cells) are the most commonly used production cells. Once a CMO successfully manipulates a cell to generate the target protein, the cells proliferate to create a reliable cell line. After the production cell line is established, CMOs generate a master cell bank using bioreactors to create hundreds of millions of identical cells that can be divided and frozen for use in future production. Bioreactors contain the necessary nutrients and conditions for optimal cell growth and target protein production. These vessels enable massive cell populations to generate the target protein product efficiently. A frozen vial of production cells from the master cell bank can be thawed and placed in the bioreactor to allow for growth when the protein product (biologic) is needed. Downstream manufacturing activities include capture and recovery to separate the product from cell debris in the bioreactor, intermediate purification to remove bulk contamination such as host proteins and viruses, and polishing to eliminate trace elements and impurities. Every product requires different conditions and parameters, making it very complex and requiring substantial time and investment, which is why many companies opt to outsource biopharmaceutical manufacturing.
Biopharmaceutical Contract Manufacturing Services
CMOs offer a variety of drug development and manufacturing services as well as relevant analytical and regulatory support. Several modern CMOs offer comprehensive solutions to support companies from discovery through commercialization and delivery. Biopharmaceutical CMOs often establish and optimize key protocols such as cell line development to reliably produce materials for preclinical research and clinical trials. With the biopharmaceutical landscape increasing in diversity, regulatory and quality guidelines are regularly changing, which can delay production and reduce speed to market if companies do not have the relevant knowledge and expertise. Regulatory support is now an expectation of CMOs to help pharmaceutical companies navigate frequently evolving guidelines and ensure compliance.
Drug substance production is the primary service of CMOs and many manufacturers offer comprehensive capabilities in terms of scale, capacity, and technology. Offerings can include characterization, solid state research, process development, analytical development, quality control, stability studies, manufacturing, formulations, dosage development, and packaging to, ultimately, determine and deliver the most productive route for drug production and get life-changing medicines to patients.
5 Biopharmaceutical Contract Manufacturing Organizations
Lonza Group AG
Website: https://www.lonza.com/
Recognized for reliable, high-quality service; global capacity; innovative technology platforms; and extensive experience. In 2019 they provided manufacturing services for over 300 commercial molecules, supported the development of over 700 pre-clinical and clinical molecules,and supported the launch of pioneering autologous cell therapies.
Pantheon by Thermo Fisher Scientific
Website: https://patheon.com/about-us/
A CDMO that has over 55 locations worldwide and offers integrated, end-to-end capabilities through all phases of development, including API, biologics, viral vector services, formulation, clinical trial solutions, logistics services and commercial manufacturing.
Cytiva
Website: https://www.cytivalifesciences.com/en/us
Formerly part of GE Healthcare Life Sciences, it is a global provider of technologies and services for fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. They operate in 40 countries and are dedicated to advancing and accelerating the development and manufacture of therapeutics.
Samsung Biologics
Website: https://samsungbiologics.com/
The CDMO with the largest single site capacity, and the fastest throughput. Samsung Biologics is an award-winning partner of choice and is a one-stop shop for development, manufacturing, and laboratory testing services at every stage for biopharmaceutical products while offering comprehensive regulatory support and contract research services.
Merck KGaA
Website: https://www.emdgroup.com/en
A global pharmaceutical and biopharmaceutical contract manufacturing organization offering end-to-end solutions for clinical drug development, scaling processes and implementing local production facilities. They have a full manufacturing process, including designing and implementing at the customer’s facility or at their GMP site. They are recognized for supporting customers move cutting-edge therapies to market with world-class process development and manufacturing capabilities for virus-based therapeutics.