Figure 3: Product mix. Total exceeds 100% because multiple responses were allowed. mAb is monoclonal antibody.
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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.
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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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