A new case study details how Brazilian pharmaceutical company Cristália enlisted Bioengineering’s engineering, automation and manufacturing services to produce their patented animal-free collagenase in a GMP, BSL-3 plant.

The downloadable PDF traces Cristália’s journey from a small psychiatric clinic in the São Paulo countryside to the first laboratory and industrial park in the country capable of manufacturing the complete drug chain.

Brazil is home to one of the richest biodiversities in the world. While bioprospecting for novel microorganisms in soil samples, a strain of Clostridium histolyticum T248 was discovered, which, after extensive assays and molecular characterizations, exhibited genetic features similar to the reference strain, and a superior yield in an animal-free medium.

The resulting enzymatic complex is used for the debridement and accelerated healing of dermal ulcers, wounds, burns and necrotic tissue, with millions of tubes of the Kollagenase ointment having been marketed after the production line was successfully approved by the National Sanitary Surveillance Agency (ANVISA) and accredited with Good Manufacturing Practices (GMP).

Over the years, Bioengineering has published a series of case studies showcasing our clients, their applications and the plants we have designed and manufactured for them. Text and scientific diagrams are provided by the customer with photography, design, layout and publication by Bioengineering.

Other editions, featuring projects such as the world’s first EMA and FDA approved biosimilar monoclonal antibody or the fast-track implementation of the world’s largest single biomanufacturing facility as of 2017 are available at this link.