Lonza is offering a fixed-price manufacturing service for generating preclinical quantities (up to 1,000 mg) of microbially derived biopharmaceuticals. The company claims its XSpedite Microbial Services™ option can deliver non-GMP proteins and plasmid DNA in 10 to 15 weeks (from strain to purified product) and guarantee the delivery of a minimum quantity after initial lab evaluation.
The new service has been designed so clients can cost-effectively accelerate early-stage microbial biopharmaceutical programs without investment in a full GMP process development program. The XSpedite Microbial Services package also provides a solid basis for future cGMP manufacturing process development, Lonza points out.
“Our customers have emphasized the value of rapid process development and supply of quantities of purified non-GMP material for critical preclinical evaluation such as proof-of-concept studies,” comments Diego Schmidhalter, Ph.D., 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 new XSpedite Microbial Services are fully complementary to Lonza’s AggreSolve™ Protein Aggregation Predictor platform for protein molecular modeling and its high-titer XS Microbial Expression Technologies™. Launch of the XSpedite Microbial Services facility comes just a week after the company announced it was combining its exclusive synthesis and biopharmaceutical business sectors into one single division, Lonza Custom Manufacturing.