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P

Protease

Biopharmaceutical Glossary

Protease designates an enzyme that catalyses the hydrolytic cleavage of peptide bonds in proteins, performing essential functions in biological systems and serving as both therapeutic targets and critical tools in biopharmaceutical manufacturing. These enzymes regulate countless physiological processes including digestion, blood clotting, immune response, and cellular signalling.

Proteases are classified by their catalytic mechanism into serine proteases, cysteine proteases, aspartate proteases, metalloproteases, and threonine proteases. Dysregulated protease activity underlies numerous pathological conditions, with excessive matrix metalloprotease activity contributing to cancer metastasis and HIV protease enabling viral replication, making proteases highly successful drug targets. Beyond their role as drug targets, proteases are indispensable tools in biopharmaceutical production for cleaving affinity tags from recombinant proteins, activating therapeutic proteins from precursor forms, and controlling glycosylation patterns during production. Quality control laboratories use site-specific proteases to generate peptide maps for protein characterisation and comparability studies mandated by regulatory authorities. The biologics industry continues developing improved protease variants with enhanced specificity, stability, and efficiency.

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