- U.S. FDA approval of Portola Pharmaceuticals, Inc.'s Prior Approval Supplement (PAS) for second-generation Andexxa® follows collaboration with Lonza Pharma & Biotech to develop the manufacturing process
- Large-scale capacity in Porrino (ES) and IbexTM Dedicate in Visp (CH) will ensure flexible commercial supply of Andexxa
- Full commercial launch is underway in the United States; CHMP opinion anticipated on 28 February 2019
Basel, Switzerland, 24 January 2019 – Following the recent U.S Food and Drug Administration (FDA) approval of the Prior Approval Supplement (PAS) for second-generation Andexxa, Portola Pharmaceuticals, Inc. and Lonza announce the start of commercial supply of the recombinant coagulation factor from Lonza's Porriño (ES) facility.
The production at Lonza Pharma & Biotech's 10,000L mammalian facility in Porriño will be supplemented by additional large-scale capacity in IbexTM Dedicate at Lonza's Visp (CH) site when it comes on line in 2020. The two sites will ensure the flexible supply of Andexxa to patients.
Lonza worked closely with Portola to develop the second-generation manufacturing process for Andexxa.
“Our teams have taken up the challenge with Portola by combining our expertise to ensure their product can reach the patients who need it,” said Sylke Hassel, Head of Commercial Mammalian and Microbial Manufacturing at Lonza Pharma & Biotech.