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Enabling small market opportunities

The impact of disposable and single-use technologies in bioprocessing has become significant over the past five years. Certainly, there are many factors driving adoption of these technologies, but two that stand out are increased development speed and capital avoidance. These two benefits can lead to improved financial returns for smaller projects by reducing the large up-front capital costs and lead-times associated with establishing production using conventional technologies. As a result, companies that would have certainly outsourced to CMOs ten years ago are contemplating (or have already begun) producing clinical trial supplies in house. Similarly, countries, frustrated by reliance on others for supply of vaccines for pandemic or regional diseases, are planning to establish manufacturing capacity using flexible, disposables-based facilities for self-sufficiency. And as personalized medicines and autologous therapies advance in research and development, the concept of manufacturing many similar products at a very small scale using fully disposable processes is no longer a pipe dream.

But are these opportunities fully enabled by disposable technologies? At a discussion panel at the IBC Antibody Production conference last March, several participants expressed concern that development and quality-related fixed costs associated with bringing new products through the approval process still pose significant hurdles for the economic viability of personalized medicine products. To fully enable the potential of smaller market products, we believe that disposable technologies are necessary but not sufficient. We must also find technologies and approaches that will “right size” such fixed costs as research and development, quality systems, and regulatory compliance. Even applications that may already be economically viable through the use of disposable technologies – like in-house production of clinical supplies and smaller-scale national based production of vaccines – would benefit from the “right sizing” of fixed costs.

In our view, the cause of this dilemma is that our fixed cost structure has grown to a size and scale that is appropriate for supporting the industry’s historical and current “blockbuster” model. We have pursued expensive development programs and built elaborate quality systems in order to buy down risk as far as possible, which is understandably justified by the magnitude of blockbuster sales in our heavily regulated market. However, if our industry is to successfully move away from the blockbuster model towards the development of larger numbers of niche products or personalized medicines, then something has to give. The question is how will we meet the growing regulatory expectations for product quality and characterization while bringing down fixed costs? It is clear that our approach to managing development, assuring product quality, and achieving regulatory compliance must become far more flexible and efficient to truly enable smaller-market product opportunities. We welcome your thoughts and ideas on how we might accomplish this. Or, if you think the blockbuster model is here to stay, we’d like to hear arguments on that side as well.