Lonza Launches XS Pichia 2.0 Expression and Manufacturing Platform for Development of Next-Generation Therapeutics

Pichia pastoris was designed as a valuable alternative to E. coli and CHO cells for production of novel protein formats such as multi-specific antibody mimetics. Lonza has established a new XS™ Pichia 2.0 system designed to provide high product titers (up to 6 g/L) for these novel compounds along with a fast, robust and scalable manufacturing process suitable for commercial production.

Scaling-up of traditional Pichia fermentation processes can be challenging due to use of methanol and complex feed regimes. In addition, the fermentation times of traditional Pichia processes require a long guaranteed sterility of the vessel and medium. To address these challenges, Lonza has developed a new proprietary expression and manufacturing system that delivers:

• High product titers
• High cell viability for improved product quality
• Drastically-reduced fermentation times that approximate E. coli processes
• Ease of implementation in large-scale plants

A model-based process development approach enables a product-specific setup based on the specifications of the full production process and the requirements of the production plant. In addition, XS Pichia 2.0 is complemented by an effective high throughput screening, which assures identification of high performing clones under fed-batch conditions.

“Lonza is committed to helping our customers develop next-generation biotherapeutics as quickly and reliably as possible,” said Karen Fallen, Vice President, Business Unit Head, Clinical Development, for Lonza. "We leveraged our 30 years of expression and process development expertise to create a system that provides a commercially-viable alternative to E. coli for appropriate drug candidates. In addition, our licensing program provides attractive options that allow use of this system in our customers’ own labs under a Research Evaluation Agreement.”