In response to growing customer demand, Lonza has introduced an unprecedented fixed-price manufacturing service for rapidly delivering quantities of microbially derived biopharmaceuticals (up to 1000mg). Lonza guarantees a minimum quantity will be delivered after an initial lab evaluation. Called XSpedite Microbial Services, the new offering integrates Lonza's existing and innovative platform technologies and systems to quickly provide non-GMP proteins and plasmid DNA for critical pre-clinical requirements in 10 to 15 weeks (from strain to purified product).

"Our customers have emphasized the value of rapid process development and supply of quantities of purified non-GMP material for critical pre-clinical evaluation, such as proof-of-concept studies," said Dr Diego Schmidhalter, head of Lonza Microbial Services. "In response, Lonza has created an integrated and streamlined service offering that can now supply high-quality product for all material needs -- from concept through toxicology, clinical and commercial supply."

The success of a drug development programme can be severely and negatively impacted by limited amounts of low-grade material for in vitro or in vivo studies. Much early-stage biotechnology research requires certain quantities of purified material for proof of concept studies as a key milestone in the evolution of pre-clinical programmes. By facilitating the efficient and rapid development of fermentation expression and purification processes, Lonza's XSpedite Microbial Services enables customers to cost-effectively accelerate early stage microbial biopharmaceutical programs without having to invest in a full GMP process development program. This service package provides a firm foundation for establishing robust cGMP manufacturing processes necessary for subsequent supplies of toxicology and clinical trial material.

The new XSpedite Microbial Services are fully aligned and complementary to Lonza's proprietary platforms for protein molecular modelling (AggreSolve Protein Aggregation Predictor) and Lonza's high-titer XS Microbial Expression Technologies. The combined services now enable molecular design through rapid strain and process development.

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture.