Facility builds and retrofits are a leading indicator of which companies will be manufacturing which products, and where, in two to five years. Until 2017, the FDA approved approximately 22 new medicines per year. Beginning that year approvals jumped to the 50-plus range, which does not include several products (and tests) released under emergency use authorizations.
Facility projects also reveal something about a potentially new business model emerging for therapeutic biotech—one that emphasizes value and quality, perhaps, rather than the blockbuster model whose success is based on sales volume.
Mike Barrett, vice president of project delivery services at CRB, attributes the expansion frenzy to “unique business drivers” and the simultaneous emergence of novel therapies and demand for them.
“These business-case criteria intersect more frequently now, and enable biopharmaceutical companies to hedge and lower their capital investment risk profiles,” he says. “Biopharmaceuticals have traditionally relied on the blockbuster model, whereas today’s risk profiles hedge pipeline depth. Each opportunity remains backed by market demand which is driving the manufacturing scale.”
Flexibility is key
Facilities, Barrett says, are incorporating flexible office, laboratory, and research spaces that promote standardizing on repeatable building blocks so they can be scaled appropriately.
“We have seen expansion plans that support higher levels of social distancing constructed now, but which may further ‘densify’ without major renovation,” he continues. “We have found using LEAN design and construction principles like TAKT planning creates a flow of construction on-site that supports social distancing policies.”
TAKT—not an acronym or a new idea—is a project-completion strategy whereby steps occurring at different rates are harmonized temporally to reduce chaos and uncertainty.
Facility expansions are also an indication of biopharma’s interest in new technologies and production philosophies, e.g., Industry 4.0 or Biopharma 4.0.
According to Barrett, CRB evaluates many innovative process technologies during early planning phases to lock in the technology selections specified by the customer’s business criteria, so the technologies that stick and eventually are utilized typically have a unique connection to that business case.
“For example, if a client has a net energy criteria high in their conditions of satisfaction, then green initiative technology may receive greater focus,” he tells GEN. “If a company has a speed-to-market condition of satisfaction, then innovation in single-use technologies will get our attention. It is rewarding to be part of projects that explore several technologic innovations on the same investment.
“This is an exciting time to be leading biopharmaceutical design and construction because the market simultaneously demands both innovation and standardization.”