Bovine Chymotrypsinogen – FAQ’s
Q: Where is the raw material sourced from?
Raw material is sourced from OIE (World Organisation for Animal Health) member countries classed as
negligible risk for BSE. The pancreas is harvested by certified establishments using approved
procedures. The importation and inspection of the pancreas is under the authority of the South African
Department of Agriculture Fisheries Forestry (DAFF) regulatory requirements.
Q: Is Chymotrypsinogen produced from bovine and / or porcine raw material?
All chymotrypsinogen produced at BBI Solutions are extracted from bovine pancreas.
Q: Where is Chymotrypsinogen manufactured?
Chymotrypsinogen is extracted and purified at BBI’s class ISO9001:2008 bulk extraction facility in
Cape Town, South Africa. Final products are prepared and packaged in an ISO 8, Class 100,000
facility.
Q: Can the product specification be customised if we need any additional testing?
Yes, we can investigate the additional requirements and will profile this specification against our current
process capability. If product specification falls outside our process capability, the project will be
handled by our R&D department.
Q: Recommended Storage conditions?
We recommend you store the material at -20°C and ship at ambient temperature.
Q: What are the key features and benefits?

Guaranteed quality: Chymotrypsinogen is manufactured under our Quality System compliant
with ISO 9001:2008, with stringent QC analysis for every batch.

High Activity: Our crystallised chymotrypsinogen has been developed over 40 years ensuring
optimal performance and the highest quality.

Batch-to-batch reproducibility: Enabling consistent formulations.

EDQM approved: We maintain a Certificate of Suitability for TSE Risk Management issued by
the EDQM for materials derived from bovine raw material.

Bulk extraction capability: We are able to offer large volumes to your exact product
specification.

Secure supply: We have direct relationships with our raw material suppliers to ensure a secure
supply chain.
Q: What volume of material can I buy?
We can produce up to 100Kg of Chymotrypsinogen per month. Product availability and lead times can
be discussed with our Account Management team.
Q: Is stability data available for materials supplied?
BBI has implemented a stability shelf-life program, which includes selected materials, and is currently
in progress. The program will be expanded to include all materials progressively. Stability data is
available for selected materials.
Q: What is the potential chymotrypsin activity?
Chymotrypsinogen is lyophilised as an inactive precursor, and does not have any activity unless it is
activated. The potential chymotrypsin activity is determined by a controlled activation sequence within
the QC laboratory to determine the potential chymotrypsin activity that can be expected.