Biopharma Embraces a Microbrewery Mindset with Single-Use Bioreactors

Biopharma Embraces a Microbrewery Mindset with Single-Use Bioreactors

This blog post serves as an introduction to the bioreactors market and an impactful biopharma industry trend. More information regarding the market for single-use bioreactors can be found in Kalorama Information’s recently publishedThe Worldwide Market for Bioreactors.

Fermentation is serious business, whether its in the biopharmaceuticals or beverage industry.  Similarities in the production processes of biosimilar drugs and beers can be spotted readily, but the comparison usually ends there for products sold in markets worlds apart. All the more intriguing when recent market forces have evoked a common response from the industries in terms of infrastructure and production flexibility.

 Both brewing and bioproduction require sanitized if not sterilized infrastructure and carefully controlled environments in terms of temperature, nutrients, aeration and circulation to ensure optimal microbial or cellular productivity. The traditional set-up for biopharmaceutical production even resembles a brewery - fixed, stainless steel bioreactors or fermenters with capacities up to 25,000 liters using impellers and temperature control coils. The fixed bioreactor and macrobrewery fermentation tank have become vulnerable, however, to shifting, and even diversifying market demand in biopharmaceuticals and beer.

In the United States, the craft beer renaissance would not have been possible without the flexibility and leanness of microbrewery and nanobrewery set-ups beginning with simple plastic or glass carboy. Small outfits and hobbyists succeeding in capturing and developing niche demand and customer loyalty by releasing a spectrum of beer styles untouched by U.S. macrobreweries or traditional industry. Attrition rates in the coalescing craft beer industry were high and remain high, if not in terms of microbreweries then at least the small-batch craft beers that could be discontinued in search of a better formulation. Limited releases reduced investment risks behind the launch of a new beer line, but upstart brewers could expand production as successful beers fetched premium prices.

A lesson could be gleaned from the craft beer industry narrative, but the distance between biosimilar and beer markets eliminates any plausibility that the biopharmaceuticals actively emulated the strategy of microbrewers (barring the intervention of some either widely active or influential microbiologists). Nevertheless, a common parable emerges with the biopharmaceutical industry’s embrace of single-use bioreactors: aim small, miss small but potentially win big.

Addressing high-volume biopharmaceutical demand necessarily involved fixed stainless steel bioreactors. The facilities require high capital investment for stainless steel, high-grade plastic or glass bioreactors and the intricate design and installation of supporting fluid handling systems (piping, filtration, pumps, condensers, valves). Traditional bioreactor facilities can cost in excess $300 million and take years to construct and prep. Operationally, fixed bioreactors have become inefficient with excess, unused capacity emerging as a result of improved cell line yields, culturing techniques and downstream processing. Fixed capacity is also unresponsive to changes in market demand. Fixed bioreactors can also drag down efficiency when multiple products are needed as intermediary cleaning and sterilization entail significant downtime.

With advances in systems biology and bioproduction, increasing numbers of biopharmaceuticals are being introduced to the market and facilities need to diversify production and frequently at lesser volumes. Several scenarios have stressed production flexibility in biopharmaceuticals including:

  • Supply chain disruptions may open opportunities for smaller batch runs;
  • drug development and other premarket or contract production is most efficient at smaller capacities with fast turnaround;
  • smaller market orphan drugs can represent lucrative business opportunities for nimble set-ups;

Single-use bioreactors have served as a common solution. In these systems, cells are grown in disposable plastic bags or tanks with plastic liners. The systems offer advantages in terms of modular production scalability, low initial costs, and mitigation of cleaning and sterilization requirements. Single-use bioreactors have also become attractive in emerging markets because of their reduced capital commitment, lesser demand on upkeep and maintenance, and the smaller size of regional targets. Single-use bioreactors can also replace capacity at the scale of fixed bioreactors at unit capacities of up to 2,000 liters each. Production risks are also importantly mitigated using single-use reactors through the commitment of less resources and facility capacity. Companies can also manage market-based risks by using single-use bioreactors to diversity production. Contamination risks can also be reduced or eliminated by making limited or one-off use of disposable bioreactors.

The strong market performance of single-use bioreactors has been a result of the rising specialization in biopharmaceutical manufacturing much as the rise of craft beer production could be sourced to growing sophistication in consumer taste. Vendors supporting client transition to more flexible operations stand to benefit from an increasingly vibrant biopharmaceuticals industry.

For an industry review of bioreactors (including single-use units), detailed market perspectives and market breakdowns, please consult Kalorama Information’s The Worldwide Market for Bioreactors.