What is biopharma contract manufacturing?
Biopharma contract manufacturing organizations provide drug companies with access to the tools and infrastructure needed in order to quickly scale up production of new drugs and bring them into the market. They provide their clients with technology that might otherwise be unaffordable, help them accelerate product entry, and allow innovators to bring new flexibility to their operations.
These are major benefits for businesses in a field where manufacturers face many challenges, including a lack of necessary equipment to create and scale up drug production in-house. By working with a biopharma contract manufacturing partner, more biotech and biopharma companies have been able to successfully launch their product than ever before. They can create standardized, straightforward contracts for easy negotiations in tightly regulated fields, addressing issues including intellectual property, prices, timelines, warranties, and liabilities—all of which can become sticking points in operations or even bring them to a halt altogether.
Why is the field growing?
Technology used in pharma manufacturing industries like EBR software which improves and bioprocessing continues to develop, drug companies are looking for new ways to bring down costs while achieving continual growth. Working with a biopharma contract manufacturer empowers them to achieve faster turnaround times and reduced expenses. These companies also help drug manufacturers complete process development, fill-finish operations, analysis, QC, and packaging—all of which could otherwise be outsourced to other partners in order to bring a drug to market.
Many different biologics products are growing in popularity globally, including monoclonal antibodies (MAbs), recombinant proteins, vaccines, antisense, RNAi, and molecular therapy treatments, to name just a few. MAbs dominated the industry in 2017, but requires substantial investment to manufacture.
A number of established players have had a foothold in this industry for quite some time, but others are quickly gaining momentum. New to the field, for example, is Samsung Biologics. Launched in 2011, the company has three plants and a production capacity of approximately 364,000 liters, and plans to start construction of a fourth facility in 2020.
What barriers are there to continuous growth?
Very large pharmaceutical manufacturers continue to express concern over the dangers of outsourcing. Specifically, they worry about losing control of their supply chain and being unable to oversee management of product manufacturing. That said, this impact does not mean that there are not substantial opportunities in the field, and that biopharma contract manufacturers will not continue to achieve growth in their industry for years or decades to come; it simply means that industry players with their own manufacturing operations will continue to utilize them.
Get To Know The Major Biopharma Contract Manufacturers
Founded in 2011 by the Samsung Group conglomerate, Samsung Biologics is a Contract Manufacturing Organization, Contract Development Organization, and Contract Research Organization that flexibly and cost-effectively produces monoclonal and recombinant drug substances and drug products. The company’s integrated services include cell line generation, process development, clinical and commercial bulk cGMP manufacturing, analytical services, and fill-finish services.
In 2019, Samsung Biologics achieved ISO27001 certification, making them the first CDMO to be recognized for information security management. They also implemented large scale N-1 perfusion for commercial application and signed a third drug manufacturing deal with UCB to produce an anti-tau candidate to treat progressive supranuclear palsy.
The company has over 2,600 employees worldwide, a total of 68 clients with global footprints, and over 60 approvals from global regulatory authorities. Samsung Biologics has also won the CMO Leadership Award for seven consecutive years, with capacity and accomplishments growing significantly over the course of the company’s first decade of existence.
Boehringer Ingelheim is a research-driven global pharmaceutical firm focused on improving quality of life for humans and animals alike suffering from diseases and conditions with no satisfactory treatment options currently in existence. The company creates therapies to extend patients’ lives and provide preventative care.
Founded in 1885, Boehringer Ingelheim has dedicated much of its resources to the study of treatment of cardiovascular disease, central nervous system diseases, metabolic diseases, virologic diseases, oncology, and respiratory diseases. With its headquarters located in Ingelheim, Germany, the company has 175 affiliates and over 50,000 employees across the world.
Lonza is a well-known contract developer and manufacturer with extensive experience in manufacturing small molecule drug substances and intermediaries. In 2019 alone, Lonza manufactured over 300 commercial molecules and helped to facilitate the development of over 700 pre-clinical and clinical molecules, as well as a number of up and coming autologous cell therapies.
Additional offerings include manufacturing of monoclonal antibodies; complex proteins and recombinant proteins; complex cell and gene therapies for patients with cancers and genetic diseases; bioscience solutions including cell culture, discovery technologies, and biomanufacturing software; and innovative dosage capsules. At nearly 40 sites worldwide and with over 11,000 employees, Lonza can provide extensive local and regional solutions to pharmaceutical manufacturing challenges.
Founded in 2002, Inno Biologics is a Malaysia-based contract manufacturer of monoclonal antibodies and therapeutic proteins. The firm’s cGMP facility provides drug companies with 200L and 1000L production bioreactors, associated inoculum suites, and the primary recovery equipment necessary to conduct cell removal and concentration and purification processes. This makes Inno Biologics uniquely qualified to facilitate development of therapeutic and diagnostic antibodies against colorectal cancer markers and several other treatments.
The company’s facilities help their clients complete all biomanufacturing needed to complete standards-compliant clinical trials, and has achieved substantial growth over the last 18 years. As of 2012, the company employed 95 people, including 35 scientists and 17 engineers, and has a wide array of exclusive partnerships in place. The company was also awarded BioSpectrum’s Asia Pacific Emerging Company of the Year in 2010.