By Bruce McCafferty and Mark Santos
The pharmaceutical industry’s targeting of new therapies for niche markets has added another dimension to traditional business models. Biopharma companies contending in this fragmented and competitive market are now under pressure to find innovative ways to get ahead of their competition and reap the first-to-market benefits. Doing so, though, means making capacity decisions long before you know how your drug will perform on the market (or if it is even approved) or waiting until clinical trial data can better guide your decisions. The latter puts you at risk of not having enough capacity when you need it, risking a drug shortage, while the former could result in capacity being underutilized. Both scenarios could have costly and damaging consequences for your brand or, more importantly, patients in need of their medication.
The alternative is to work with a CDMO. With outsourcing, the onus is no longer on you, the biomanufacturer, to ensure you build the appropriate capacity for your product’s launch. Nevertheless, the partner you select must be able to respond appropriately to fluctuations in demand in order to maintain reasonable operational and capital expenditures. This requires facilities designed to ensure a reliable delivery of materials for clinical through commercial manufacturing, including a wide range of bioreactors to suit changing volume needs. Stainless steel bioreactors that can hold a wide range of volumes have historically been the go-to for drug manufacturers. Yet, the advent of single-use technology (SUT), which enables faster process changeover, lower investment costs, and smaller facility footprints, provides the opportunity to manufacture a drug at volumes of 2,000 liters or less, a significant advantage in today’s evolving landscape. However, the disparity between these bioreactor volumes leaves little room for demand flexibility between large- and small-volume needs. One solution is to use mid-volume capacity bioreactors, which offer agility in an unpredictable industry while also balancing the cost of goods as a program prepares to launch.