The Biopharmaceutical Manufacturing Survey - Pharmaceutical Technology

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The Biopharmaceutical Manufacturing Survey
A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 7

Figure 3: Product mix. Total exceeds 100% because multiple responses were allowed. mAb is monoclonal antibody.
The press has been so focused on monoclonal antibody (mAb) drugs, that we were surprised to learn that a majority (56%) of respondents manufacture protein and peptide drugs other than mAbs, which are manufactured by 43% of respondents. Almost 18% of respondents manufacture nucleic-acid based drugs, and 17% of respondents manufacture cells for tissue and cell therapies—a field on which many are heaping high hopes, especially now that government funds are available for embryonic stem-cell research (see Figure 3). Thirty-eight percent expect their companies will manufacture follow-on biologics; 22% expect their companies will not manufacture follow-ons; and 39% don't know.

Production challenges

Figure 4: Technical problems reported in protein manufacturing. Total exceeds 100% because multiple responses were allowed.
We queried respondents about the challenges they face manufacturing their respective products, and among manufacturers of protein-based drugs, we found something of a schism. Fifty percent—fully half—of those producing protein drugs, including mABs, said that they had difficulty producing high enough product yields. And yet 44% reported that purifying protein products was a challenge because yields were so high. Product instability was a problem for almost 40% of respondents, while contamination was a problem for 20% (see Figure 4).

Stability seems to be a problem confronting 56% of producers of nucleic-acid based drugs, with another 50% reporting difficulties with purifying these products. Thirty-six percent have formulation problems, and almost 28% find it a problem to produce adequate yields.

Industrial-scale cell manufacturing is still in its relative infancy, as evidenced by the fact that 62% of respondents said that developing a manufacturing process posed a challenge to them. Forty-three percent reported difficulties maintaining product stability and uniformity, while 32% said that formulating cell-based therapies posed a challenge. Almost 30% have difficulty finding bioreactors of adequate volume to accommodate their product yields.


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