Lonza Launches XSpedite Microbial Services™ for Pre-clinical Quantities
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 program 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 programs. 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 modeling (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.
For more information, please contact one of our experts:
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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. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.
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