New and Unknown Challenges Facing Biomanufacturing

Upstream and downstream processing in biomanufacturing follow different rules. Upstream processing is biology-driven, and a lot of black box issues remain to be explored. On the other hand, purification is clearly engineering-driven and can be described and simulated with the precision of mathematical models. However, despite our still-limited knowledge of cells as bioreactors, it is upstream fermentation that is setting the pace. Downstream processing is having a hard time accommodating the output of this revolution in biosynthesis development. In any case, the two separate areas must be aligned and integrated in order to manage the challenges that lie ahead. But what are those challenges, and what technical solutions are available?

THE BIOTECH SECTOR TO DATE: FULL PIPELINES AND EMPTY POCKETS

The days are over when time was the only thing that mattered and resources seemed unlimited in biotechnology. Initial public offerings (IPOs) poured lots of cash into startups and second-generation biotech companies, creating a big bubble that remains a liability today. Those who thought biotechnology was delivering on all the premature hopes and unrealistic expectations raised by the human genome initiative ignored serious warning signs. Nevertheless, it is fair to say that ratings in the biotech sector were never as absurd as in other areas, such as the dotcom sector. Now that the grace period is over, consolidation is occurring and biotech mustdeliver on these raised expectations. Is there a doubt that the sector will deliver? Absolutely not. More than 150 new biological entities (NBEs) are on the market and hundreds of promising second-and third-generation products addressing unmet medical needs are in development. In addition, the pharma-biotech industry is generating a sustained flow of positive news and will eventually come out stronger than ever .

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