The Market
Given their specificity, biopharmaceuticals can cure diseases, not just treat symptoms, whilst often causing fewer side effects. As the number of new diseases that can be treated with biopharmaceuticals increases, so does the demand for these around the world. Biologics, which constitute 30% of all therapeutic compounds being developed, are very popular among Pharma companies and the country’s protein therapeutics market is expected to grow significantly by 2010. Within this group, one of the most important biotherapeutics is monoclonal antibodies, and this global market is estimated to grow by billions of dollars.
Why Outsourcing Biopharmaceutical Manufacturing Works?
- Biopharmaceutical products must be manufactured under the current Good Manufacturing Practice (cGMP) conditions for clinical trials. Manufacturing for biologics is technologically complex and highly regulated by the FDA; this requires a great deal of experience and special skills to be able to produce large complex protein structures on a large scale. The smallest of variations can alter the process, stability, and efficacy of the final product. The manufacturing personnel must possess technical expertise in upstream and downstream operations, process development, project management, process engineering, quality assurance, analytical development, quality control, and regulatory compliance, among other specialized functions.
- The investment of capital to build a manufacturing facility is enormous, going up to many $100 millions in some cases, and it takes several years for a facility to be ready for operation. Large Pharma companies are able to build their own cGMP compliant manufacturing facilities, but small or medium companies are not.
With the maturity of the biopharmaceutical industry, the option of Pharma outsourcing services has become a viable and necessary production strategy. Pharma outsourcing companies offer an attractive high-quality and economical alternative for all size companies, from virtual ones to large conglomerates.
By outsourcing some processes, Pharma companies can center their activity on their main capabilities while lowering production costs, improving manufacturing efficiency, minimizing risk, and decreasing development timelines. They will be spending their resources in what they know to do best.
Contract manufacturing organizations (CMOs) offer services ranging from cell-line development, cell banking, bio-reactor production, process development, protein purification, scale-up, pilot scale production, cGMP production, analytical and testing services, validation, quality control testing, protein conjugation, modification and radiolabelling, to final formulation, lyophilisation, fill and finish. It is clear they cover the whole spectrum of Pharma drug development and manufacturing processes.
CMOs play an important role in the Pharma industry, and they are a great way to give value to your clients. They are prepared to design the best process suitable for each situation. Ask your pharmaceutical consultant about this option; they will be able to explain how this kind of outsourcing can work for you.
