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Contract manufacturing by biopharmaceutical and biotechnology outlets is on the rise as these companies look to optimize manufacturing capacity by either outsourcing or manufacturing for others. Outsourcing to Top Biopharma Contract Manufacturing Organizations (CMOs) is a valuable and critical option. That allows companies to divert their resources and talents to focus on their primary objectives. In many, the skills, equipment, or experience needed for certain R&D processes and manufacturing tasks may not be available in-house. So, for the biopharmaceutical and biotech industry, CMOS serve as capacity reservoirs for companies to tap in as needed.
What makes this challenge so unique? That is biopharma manufacturing has certain special requirements and differences when compared to traditional pharmaceuticals. Their main manufacturing product is generic drugs and other small molecules. On the other hand, the biopharma industry specializes in producing large molecules like antibodies, vaccines, recombinant proteins and enzymes, antibiotics and hormones, and other novel technologies such as cell and gene-based therapy. The stringent manufacturing guidelines, resources, and skills needed to produce the above are available only with a few select Top Biopharma Contract Manufacturing Organizations (CMOs) who are at the forefront in this specialized marketplace.
1. Samsung Biologics
Samsung Biologics was established in 2011 when its parent company decided to diversify into the biopharmaceuticals and CMO space. Since then, Samsung Biologics has undergone massive expansion to become the number one biopharma CMO/CDMO since 2018. Samsung Biologics’ first two biopharmaceutical manufacturing plants were built in Incheon. The first plant accommodated six stainless steel bioreactors with an upstream capacity of 5,000 liters. Each with a total capacity of 30,000 liters. It designed and built to carry rapid high protein production. Within the plant are suites for upstream, downstream, filling and finishing units, an administration building, and a warehouse with long-term cold storage capacity. The second biopharmaceutical manufacturing plant contains ten bioreactors with an upstream capacity of 15,000 liters each and a total capacity of 150,000 liters.
This allowed the company to enter the mammalian cell culture sphere, whose industrial working requirements mandated bioreactor capacities of 12,000 liters or more, a space previously occupied only by Boehringer Ingelheim and Lonza. The completion of the second facility allowed Samsung to offer services such as cell line generation, process and analytical method development, and analytical services at its facilities. Samsung Biologics opened its third biopharmaceutical manufacturing plant in Songdo in 2018 with an annual production capacity of approximately 180,000 liters a year. Combined with the two former units, it increased total production capacity to 364,000 liters at a single site, exceeding those of Lonza (260,000 liters) and Boehringer Ingelheim (240,000 liters), making Samsung Group one of the world’s largest CMO’s.
2. Boehringer Ingelheim
In 1885, the German manufacturing company established. While evolved into its current form through the merger of Boehringer Ingelheim KG and Dr. Karl Thomae GmbH, making it one of the largest biopharmaceutical companies in the world. While, the R&D arm of the company is focused on the development of innovative drugs for cardiovascular disease, respiratory diseases, CNS disorders, metabolic and viral diseases, and cancer therapy. The company also specializes in mammalian cell-based bioproducts with its bioreactor capacity reaching a total volume of 240,000 liters.
In 2008, it acquired Actimis Pharmaceuticals (for $515 million). They had an asset swap with French drugmaker Sanofi (worth $12.4 billion). The company also entered immuno-oncology therapy with OSE Immuno-therapeutics in 2018, worth $1.4 billion. As of now, the company has assets worth $30 billion and an operating revenue of $20 billion. The company offers tailor-made contract development and manufacturing services to the biopharmaceutical and biotechnology industries, providing the entire production technology chain from DNA to fill and finish under the same roof.
3. Lonza Group AG
Lonza Group is a Swiss pharmaceutical and biotechnology company founded in 1897 with headquarters in Basel, Switzerland. The Lonza Group has two main divisions. The first is Lonza Pharma, Biotech & Nutrition, which provides a wide range of services and products from early phase discovery to custom development and manufacturing of active pharmaceutical ingredients (APIs) to innovative dosage forms for the pharma, consumer health, and nutrition industries. The other, Lonza Specialty Ingredients focuses on microbial control for personal care. And also use for the protection of homes, schools, workplaces, and environments from potential pathogens. This division also offers custom development and manufacturing of specialty chemicals and composites to support the electronics, aerospace, food, and agrochemical industries.
The company is also one of the few outfits with experience and skill in mammalian cell culture processing with a bioreactor capacity of 260,000 liters. Furthermore, In 2011, Lonza acquired the American chemical manufacturers Arch Chemicals for $1.4 billion. And the gelatin-capsule manufacturer Capsugel for $5.5 billion in 2016. Lonza group has procured CMO projects for producing monoclonal antibodies from GlaxoSmithKline. And biological manufacturing from Bristol-Myers Squibb in 2010 and 2014 respectively. The company has assets worth $21.8 billion and a sales revenue of $5.7 billion. Lonza today has more than 15,500 employees and operates 120 sites and offices in more than 35 different countries.
4. Sandoz/Novartis
Novartis AG is a publicly-traded Swiss holding company that operates the Novartis Group. Apart from being a Top Biopharma Contract Manufacturing Organizations (CMOs), it is also one of the largest pharmaceutical companies worldwide by market capitalization and sales. In 1996, from the merger of two Swiss companies. A new company Novartis was created. 1 is Ciba-Geigy, while second is Sandoz Laboratories. The company’s global research operation is called Novartis Institutes for Biomedical Research (NIBR), While located in Cambridge, Massachusetts.
NIBR has two institutes that focus on developing drugs and vaccines for infectious diseases endemic to the developing world. The Novartis Institute for Tropical Diseases works on tuberculosis, dengue, and malaria, and Novartis Vaccines Institute for Global Health, works on Salmonella typhi (typhoid fever) and Shigella. The company also participates in publicly funded collaborative research projects with other industrial and academic partners. For the fiscal year 2019, Novartis reported earnings of USD 11.732 billion, with an annual revenue of USD 48.677 billion.
5. Catalent, Inc. (Catalent Pharma Solutions)
The catalent is a multinational corporation in New Jersey. These companies involves in biologic, drug manufacturing, and gene therapy services. Catalent Biologics has partnered with AstraZeneca PLC to prepare for large-scale. The commercial supply of the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The company acquired Paragon Bioservices in 2019 (for $1.2 billion) to expand into the gene-therapy arena. Catalent Cell & Gene Therapy specializes in adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production.
Catalent Cell & Gene Therapy has a global network of dedicated large-scale clinical and commercial manufacturing facilities for cell and gene therapy, and fill-finish and packaging capabilities located in the U.S. and Europe and has produced more than 100 cGMP batches across 70+ clinical and commercial programs. Catalent employs over 13,500 people, at more than 40 facilities, and generated over $2.5 billion in annual revenue in 2019.
