Commercial production by CDMO Lonza follows the recent US FDA nod for Portola’s Prior Approval Supplement (PAS) for recombinant factor Xa product Andexxa.
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
The production of this second-generation Andexxa [coagulation factor Xa (recombinant), inactivated] has now begun, with Swiss contract development and manufacturing organization (CDMO) Lonza supplying the recombinant coagulation factor from its Porriño, Spain facility at the 10,000 L scale.
“We worked with Portola to develop this second generation manufacturing process that has now been approved for commercial supply by the FDA,” Sylke Hassel, head of mammalian and microbial manufacturing, Lonza Pharma & Biotech, told us.
Portola Pharmaceuticals received US Food and Drug Administration (FDA) for this second generation manufacturing process for its reversal agent for Andexxa late last year.
The product launched in May 2018, with fellow CDMO AGC Biologics supplying the bulk drug substance. However, this first generation had a limited rollout, leading to the firm submitting a prior approval supplement (PAS) to the FDA in August, aimed at producing enough supply to stock more than 1,000 hospitals.
According to Hassel, the tech transfer ran smoothly. “Our commercial mammalian facilities are based on standard platforms and teams receive standard training. We also move the team with the product to ensure a smooth transition.”
She continued: “Tech transfers are a regular part of our business – we supported 22 commercial scale biologics in 2017, including mammalian manufacturing, which gives you a sense of the number of tech transfers we do.”
The CDMO is also intending to supplement production of Andexxa from its facility in Visp, Switzerland.
“Visp will also be in large-scale stainless steel. For the scale that Portola need – commercial supply – stainless steel is the most cost-effective option.”
In September, Lonza ploughed CHF 400 million ($415 million) into its Visp site to expand its Ibex manufacturing offerings, first launched in July 2017.