Pharmaceutical Development

PBL case study featured in July edition of Manufacturing Chemist

The challenge was the conversion of the production of an enzyme product from a native Pseudomonas system to a recombinant system in Escherichia coli. For this product, the development and alteration of the manufacturing process was done in a quick and efficient manner, leading to vast improvements in yield and method of production.

The gene was successfully transformed into E. coli and the target enzyme expressed, purified, and verified in terms of sequence and performance in the intended application. The entire process, from initiation to proof-of-concept data, took only a matter of months, and demonstrates that modern bioinformatics can be used to drive innovation in process development for recombinant proteins and enzymes.

In the attached article we demonstrate how the application of modern molecular biotechnological and purification techniques, in parallel with a rational process development protocol, has been demonstrated to deliver significant improvements in yield, purity and activity.  A principle applicable to other legacy products which PBL is able to offer to customers.

The full article can be viewed in the July edition of Manufacturing Chemist.

Fermentation capabilities