Laureate Will Apply Boehringer's Manufacturing Technology

Laureate Pharma (Princeton, NJ, www.laureatepharma.com) has signed an agreement with Boehringer Ingelheim (BI, Ingelheim, Germany, www.boehringer-ingelheim.com) for access to BI’s comprehensive manufacturing technology platform for biopharmaceutical products produced by mammalian cell culture. Through this collaboration, Laureate aims to help its customers increase yields, enhance overall manufacturing efficiency, and reduce costs.

“Boehringer’s proprietary gene expression system, BI HEX, enables fast-track development of high-quality processes for producing biopharmaceuticals with CHO cells,” said Dr. Andreas Werner, director of biopharmaceutical production coordination at BI. BI HEX combines several technology platforms, Werner explained, including vector systems, serum-free transfection, selection and cultivation of suspension adapted CHO-DG44 cells, serum-free FACS-based automated single cell cloning, and cGMP cell banking of master and working cell banks in chemically defined media.

Through this collaboration, Laureate will offer its clients bioprocessing services that include: creation and development of production cell lines using the BI HEX expression system; full-service process development and manufacture of early stage clinical supplies at Laureate’s cGMP manufacturing facility in Princeton, NJ; and access to large-scale commercial production by Boehringer Ingelheim at its facility in Biberach, Germany.

“This collaboration will help customers whose processes have low yields and where traditional cell line optimization techniques are not sufficient to increase yield rates,” said Mike Cavanaugh, vice president of sales, marketing, and business development at Laureate Pharma. “Access to BI-HEX will potentially increase yields and positively impact overall manufacturing efficiency.” Once early clinical phases are completed at Laureate, and when large-scale manufacturing is required for Phase 3 and commercial product, access to BI’s mammalian cell culture capacity of over 180,000 L will be a major advantage, he said.

For customers who choose to use the BI-HEX platform, cell line development, including clone development, will be performed at BI. An early clone transfer, including the transfer of a media package to Laureate, will ensure the timely uptake of the project in order to start further process development at Laureate. Early preparation for the manufacture of clinical Phase 3 material at BI will save additional time when the process is transferred back for late stage production.

“To ensure a seamless transfer, Boehringer will provide Laureate with certain process formats, which fit exactly into the large-scale production facilities of Boehringer,” said Cavanaugh. This, he added, will save the client substantial time that usually is needed to adapt the process after it has been transferred to a different facility. “The biggest challenge will be to fully understand and harmonize differences inherent in our existing equipment at the two companies and develop concise and effective transfer methodologies,” he said.