Drug launches face intense competition, especially those involving biologics. Biologics are large molecule drugs isolated from living organisms that are used as targeted therapy to precisely regulate disease pathways. Pharma companies tend to focus on the same pathways, so a biologic that gets to market first, or one with more recognized value, can become the market leader for a specific indication. A blockbuster biologic can generate millions of dollars in profit, but it comes at a cost.
Biologics require much higher development and manufacturing costs than classic small molecule drugs. Because of the large expense, and long development time, pharma companies developing biologics try to balance the timing of their investments in research and development versus manufacturing. They usually delay capital expenditures until the drug shows positive results in clinical trials, indicating it has a high chance of success, before funding manufacturing efforts.
Once the drug is approved, manufacturing it quickly is of utmost importance because each day the drug is not supplied to the market is a day a patient could go without a potentially life-saving treatment, as well as a day of lost revenue and expired patent protection. Although a contract manufacturing facility (CMO) is often used to expedite manufacturing of a small molecule drug, many biopharma companies choose to build their own bioprocessing facilities for a biologic drug to retain full control over product quality and certainty of supply. Even if outside manufacturing were to be considered, CMOs in many parts of the world lack deep understanding of the mechanisms of drug action for manufacturing biologics.
When a pharmaceutical company decides to build a manufacturing facility, it is always a rush to complete. Building a facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in structural design and engineering, process flow, equipment, automation, and information technology networking. If it is the company’s first time manufacturing a biologic drug, staff will need to be hired and trained.
BeiGene, a commercial-stage biotechnology company with a largescale biological manufacturing facility currently under construction in Guangzhou, China, can attest to these challenges.