
- BioPharm International-06-01-2006
- Volume 19
- Issue 6
From the Editor in Chief: When Does Glycosylation Matter?
The belief that glycosylation is critical to ensuring the functionality of protein therapeutics-and preventing immunogenicity-drives many manufacturing decisions. But is it time to question this industry tenet?
The belief that glycosylation is critical to ensuring the functionality of protein therapeutics—and preventing immunogenicity—drives many manufacturing decisions. But is it time to question this industry tenet?
Laura Bush
At an April conference on vaccine manufacturing sponsored by the Institute of Medicine and the National Academy of Engineering (
And most therapeutic proteins, Estell said, do not require glycosylation to ensure their efficacy or important properties.
If that's true, why isn't the biotech drug industry using industrial biotechnology methods?
In fact, some are. Every year, more than $13 billion of injectable and oral antibiotics are produced through fungal fermentation. But most of the industry is not. The disconnect, according to Estell, is that the biotech drug industry became fossilized in 1982, when it switched to CHO cells and decided that the high cost of products derived from CHO cells didn't matter, because the doses were small.
These statements are provocative. But many in the industry will admit that their belief that glycosylation occurs properly in the proteins they manufacture is based more on assumptions than science. In many cases, it's not considered cost-or time-effective to fully characterize protein drug products. The thinking is, "If it weren't working, we'd know it." That is odd. If glycosylation is critical, why aren't we clearer about how well we have controlled it?
Perhaps the reality is that glycosylation is not as critical as we think.
Articles in this issue
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Final Word: The US is Falling Behind on Generic Biopharmaceuticalsover 19 years ago
Filter Integrity Testing in the Pharmaceutical Process Environmentover 19 years ago
Producing Proteins Using Transgenic Oilbody-Oleosin Technologyover 19 years ago
Regulatory Beat: FDA's Field Force Does More With Lessover 19 years ago
Pursuing Pharmaceutical Quality and EconomyNewsletter
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