Biopharma's capacity crunch
Over the next few years, the industry will be hard pressed to meet demand for promising new protein-based therapeutics that are now emerging from the laboratories. Manufacturing shortfalls in physical capacity and talent could spell lost revenues for companies through the middle of the decade.
The capacity gap is caused by:
- Large capital requirements: With the high cost of developing a drug, its limited patent life, and the increasing competition in biologics, companies must capture every day of revenue by ensuring an adequate supply of their products;
- Long build-out period: Producers-biopharmaceutical companies and contract manufacturers alike-are now tripling their production capacity, but new plants take three to five years to design, build, and certify;
- Shortage of talent: Experienced process-development scientists and engineers, validation engineers, quality assurance personnel, and plant managers are already in short supply. Furthermore, universities are not producing anywhere near as many qualified manufacturing specialists as the industry needs;
- Success of monoclonal bodies: Much of the demand is driven by monoclonal antibodies, a powerful class of therapeutic proteins that must be administered in extremely high doses and can currently be produced only in mammalian cell-culture facilities. Yet the current worldwide cell-culture capacity of 450,000 liters is almost fully utilized;
- Prior regulatory contents.
What companies need to do :
- Develop a biologics-manufacturing strategy: Even at a cost of some $300 million to $500 million a plant, expansion is warranted. Our analysis suggests that for some biologics facilities would be profitable even if as little as 25 percent of capacity were used.
- Reduce the shortage of talent: US companies are not only expanding overseas to tap the large, educated labor pools of Europe and Asia but also working to bring foreign talent to the United States.
That is why industries need to :
- Reinforce linksbetween the commercial world of biopharma and academics;
- Leading companiesto form allianceswith local universities and research institutions;
- Sponsorcooperative programs;
- Hostforumsandpresentationsfor students.
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