GMP Grade

Recombinant Carboxypeptidase B, GMP Grade

CAS No. 9025-24-5

GMP-grade C-Terminal Cleavage Enzyme for Biologics Manufacturing

Recombinant Carboxypeptidase B, GMP Grade

Ordering Information

Size / FormatCat. No.DescriptionAction
1 gPB-05-001gRecombinant CPB, GMP Grade, 1 gOrder

Overview

GMP Grade rCPB is the regulatory-compliant manufacturing counterpart to Sequencing Grade CPB, produced under GMP conditions with full documentation support. It is used as a downstream processing reagent in mAb manufacturing to enzymatically control C-terminal Lys/Arg heterogeneity as a CQA management strategy. Full traceability and defined specific activity support process validation across development and commercial manufacturing.

Validated for Insulin & Biosimilar Manufacturing
IEX-Compatible for Downstream Processing
High Purity >99% by SDS-PAGE
High Specific Activity Pharmacopoeial Grade

Key Benefits

GMP-grade manufacture with full documentation support including Certificate of Analysis and Certificate of Origin

Specifically cleaves C-terminal Lys and Arg residues for controlled removal of basic C-terminal heterogeneity

Recombinant and animal-component free and is suitable for GMP-compliant downstream processing

Defined specific activity and purity specifications for process validation support

Available in 1 g format for manufacturing-scale applications

Compatible with standard biopharmaceutical processing buffers

Supports ICH Q6B CQA management strategies for therapeutic monoclonal antibodies

Product Specifications

GradeGMP Grade
Enzyme SourceRecombinant; animal-component free
SpecificityCleaves C-terminal Lys and Arg residues
FormFrozen Liquid
Storage Condition−15°C to −25°C
Optimal pH7.5–9.0
CofactorZn²⁺ (metalloenzyme; avoid metal chelators such as EDTA)
Purity>95% by SDS-PAGE; CoA provided per lot
DocumentationCoA, Certificate of Origin, GMP compliance documentation available

Applications

C-Terminal Processing in mAb Manufacturing
Process Development and Scale-Up
Release Testing
Comparability Studies
Multi-Enzyme Manufacturing Workflows

Frequently Asked Questions

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