What are Serine Proteases?
Serine proteases are a class protein catalyst (enzymes) that cleave amide bonds in other proteins and have a conserved serine residue at their active sites. This group of powerful enzymes are found in virtually every type living organisms and are involved in many physiological functions including digestion of food, blood clot formation and fighting infection. They are also implicated in many diseases, including infectious and degenerative diseases, inflammation, cancer, and many others.
Why is Serine Protease impurity removal important for biopharmaceutical?
Presence of residual serine proteases in the final biopharmaceutical drug can have a significant impact on the long-term stability of the preparation. Protease catalysed hydrolysis of the amide bonds leads to degradation and aggregation of products leading to presence of peptide fragments and increased heterogeneity. To minimize the impact serine proteases derived from the expression system (host cell protein), affinity chromatography can be used to remove this impurity in the purified product to an acceptable level. This strategy mitigates against the requirement to use of protease inhibitors in the downstream process.
p-Aminobenzamidines are potent synthetic inhibitors of serine proteases and immobilized para-isomer of Aminobenzamidine has been used in the purification of a large number of serine proteases and esterases by affinity chromatography including trypsin, thrombin, kallikrein, urokinase, acetylcholinesterase and alkaline phosphatase. It can also be used to separate one serine protease from another (for example, trypsin and chymotrypsin) and for the removal of trace proteases to stabilise protein product from proteolytic degradation.
Key Features of p-Aminobenzamidine AP6XL:
- Affinity purification and removal of serine proteases
- High purity p-aminobenzamidine ligand
- Ligand binds selectively to the active site of serine proteinases
- High dynamic binding capacity
- Sanitisable with 20% ethanol/1.0M acetic acid or 8M urea allowing multiple cycles
- Highly reproducible batch-to-batch manufacture to ISO 9001 standard
- Supported with a comprehensive Regulatory Support File
- Multiple end users in regulated bio- pharmaceutical development and manufacturing scale processes