About Biopharma Contract Manufacturing
Biopharma contract manufacturing companies are businesses designed to help solve the unique challenges facing drug companies as they produce, test, and ramp up production of a wide array of complex drug products and successfully bring them to market.
For many drug manufacturers who aren’t as large as the industry’s major players, and especially for start-up drug companies, there are major financial barriers when it comes to access to equipment and resources, and biopharma contract manufacturing helps to fill these gaps and enable delivery of a wide variety of new treatments and technologies.
Through partnership with biopharma contract manufacturers, developers can scale up production on a leaner investment, more easily negotiate contracts and get approvals when working in fields that are tightly regulated, and solve some of the most common problems affecting drug companies when it comes to warranties, liabilities, timelines, drug pricing, and use of intellectual property. Any one of these issues can stop a drug with life-saving potential from ever reaching the market, and these partnerships are a proactive and effective solution.
A rapidly growing field
As of 2017, the global biopharmaceutical contract manufacturing market was worth approximately $9.6 billion USD. Year after year, this field continues to grow as contract manufacturers continue to enable the production of new drugs. By eliminating in-house manufacturing, which sometimes lacks the expertise necessary to produce drugs efficiently and effectively, contract manufacturers have grown and flourished in a fast-developing global marketplace.
Based on a report published in 2017, Monoclonal Antibodies (MAb) were responsible for the majority of contract manufacturers’ market share, with recombinant proteins, vaccines, antisense, RNAi, and molecular therapy following in that order. This is predominantly due to the fact that MAb plants are extremely expensive, and contract manufacturers can provide enormous value by helping drug companies sidestep these enormous startups and scale up costs as they launch new products and projects.
One sticking point, however, is the fact that very large drug manufacturers have proven resistant to outsourcing their manufacturing operations, as they do not want to lose control or managerial oversight of their products. That said, contract manufacturing has simply not yet been proven viable for those companies, and this may change as businesses find new efficiencies and technology continues to improve.
A global industry
Many of the largest contract manufacturing organizations are located in North America, but major players are emerging in China, India, and Korea, as well. For example, Samsung Biologics, founded in 2011, has experienced substantial growth year after year, providing drug manufacturing services in three plants from a single facility within South Korea. Other companies, some of which are listed below, have major presences in Europe, Latin America, and in the Middle East and Africa as well.
Major players in the global biopharma contract manufacturing industry
Listed below is a small survey of some of the major manufacturers providing comprehensive services in this field.
Samsung Biologics is a company founded by South Korea-based Samsung Group to provide Contract Development Organization (CDO), Contract Manufacturing Organization (CMO), and Contract Research Organization (CRO) services to drug companies. They offer a wide array of integrated services, including process development, cell line generation, analytical services, clinical and commercial bulk cGMP manufacturing, and fill-finish service. As a whole, they empower drug companies to create recombinant and monoclonal drug products and substances in a flexible, scalable, and cost-effective way, overcoming some of the toughest challenges and barriers to entry that stops companies from achieving major drug manufacturing.
In addition to their comprehensive toolkit as a drug manufacturer, Samsung Biologics is also ISO27001 certified. This uniquely positions them as the first CDMO to be recognized for information security management practices. In 2019, Samsung Biologics also made a major expansion of their biomanufacturing capacity, giving them the ability to perform N-1 perfusions at large scale for commercial application.
With over 2,600 employees internationally and over 30 major clients, as well as 22 successful inspections and more than 50 approvals, Samsung Biologics is on track to continue to thrive and expand well into the future.
Rentschler Biotechnologie GmbH
Rentschler Biopharma is a full-service CDMO that provides comprehensive outsourcing services for bioprocess development, cGMP manufacturing, and approval strategies. Headquartered in Laupheim, Germany and with an additional site in Milford, Massachusetts, they provide extensive expertise in consulting and solutions delivery.
Since its founding in 1927, Rentschler has remained independent and family-owned, and has cultivated extensive experience with Interferon products, including Fiblaferon and Polyferon, and helps drug manufacturers work with over 200 different antibodies, fusion proteins, and enzymes. They are a preferred outsourcing partner for over 100 clients around the world.
JRS Pharma is a biopharma contract manufacturer with a focus on excipients, coatings, and formulations for solid and liquid dosage manufacturing. With a presence all over the globe, the company’s portfolio includes binders, disintegrants, lubricants, functional fillers, thickeners, stabilizers, and carriers, and they provide extensive technical support and services to help customers develop and deliver the formulations their customers need.
Founded in 1878, the company serves more than just the pharmaceutical industry, providing nutraceutical products, contract pharma services including scale up, quality assurance, and optimization, and custom health treatments in veterinary medicine for both livestock and companion animals. All JRS Pharma products are cGMP and ISO9001 certified, and the company’s excipients meet NF, JP, and Ph. Eur. requirements.
AGC Biologics creates tailored, custom services for manufacturers scaling up and overseeing cGMP manufacturing of protein-based therapeutic treatments at every stage from pre-clinical to commercial production. AGC allows clients to complete projects at facilities in the United States, Europe, and Japan, including cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking, storage, and protein expression. The company also has a proprietary expression system, CHEF1, to efficiently produce protein with CHO cells.
Currently, the company has over 850 employees, providing solutions to unique challenges for over 100 clients across five continents. AGC Biologics facilities are also ISO14000 certified to ensure minimal impact on the environment.