Lonza To Commence Commercial Supply Of Portola's Second-Generation Andexxa
- 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 Ibex 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
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 secondgeneration 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.
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. As an integrated solutions provider, Lonza is boosting its value creation along and beyond the healthcare continuum with a strong focus on patient healthcare, consumer preventive healthcare and consumer's healthy environment.
Lonza harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life. With the recent Capsugel acquisition, Lonza now offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries.
Benefiting from its regulatory expertise, Lonza is able to transfer its know-how from pharma to hygiene and fast-moving consumer goods all the way to coatings and composites and the preservation and protection of agricultural goods and other natural resources.
Founded in 1897 in the Swiss Alps, Lonza today is a wellrespected global company with more than 100 sites and offices and approximately 14,500 full-time employees worldwide. The company generated sales of CHF 5.1 billion in 2017 with a CORE EBITDA of CHF 1.3 billion. For more information, visit www.lonza.com.
Source: Lonza Ltd.