CPhI debut for Amberzyme technology

The recently-formed Advanced Biosciences unit of Rohm and Haas has introduced the first product in a new line of functionalised resin systems for the immobilisation of biocatalytic enzymes at the CPhI meeting in Frankfurt, Germany.

A spokesman for the company told In-pharmatechnologist.com that the Amberzyme oxirane product is used in the manufacture of beta lactam antibiotics and should be commercially available before the end of the year. Others are in the pipeline but details could not be disclosed.

The technology is based on Applied Biosciences' expertise in ion exchange resins and beads as biocatalysts. This rests on the principle of taking an enzyme that is highly-specific for a chemical reaction and would have activity at near-ambient temperature in an aqueous environment, and substituting a bead-anchored reagent that can extend the enzymatic activity and improve its stability at higher temperatures (e.g. 200-300 degrees C).

Attachment to a bead also means that the reactions require no solvents and the reagent is cyclable and can be re-used, he noted.

Amberzyme oxirane was developed alongside antibiotic manufacturers to overcome problems associated with alternative products serving this particular application: the covalent immobilisation of common peniccilin acylase enzymes.

The problem with competing products detailed by manufacturers, said the company, included inconsistent product performance with respect to enzyme loading, stability in use, random carrier morphology and high swelling of the enzyme.

Amberzyme oxirane addresses these customer issues by providing an enzyme carrier which is consistent in size shape, has excellent shear resistance to avoid fracturation during process cycling and is low swelling to improve capacity utilisation in existing process tanks.

"Amberzyme oxirane retains more than 99 per cent intact activity even after 1, 000 cycles,"​ said the spokesman.

Applications testing shows Amberzyme oxirane to have superior physical bead stability, equivalent or better on bead enzyme activity and a lower level of bead swelling upon hydration in water or aqueous buffers. This means less bead breakage (which can create real problems for follow-on filtration systems), a longer usage times in stirred-batch applications, as well as significantly lower costs in compound use (e.g. Reagents) and high efficiency in terms of reduced levels of random by-products that make downstream purification easier.