Mfg News: BI, Ascendis Pharma & Fusion Pharma By
A roundup of manufacturing news from Boehringer Ingelheim, Ascendis Pharma, and Fusion Pharmaceuticals. Highlights below.
* BI Investing $313 M for Chemical Mfg Innovation Center
* FDA Issues Complete Response Letter to Ascendis Pharma for Mfg Issues
* Fusion Pharmaceuticals Opens Radiopharmaceutical Mfg Facility
BI Investing $313 M for Chemical Mfg Innovation Center
Boehringer Ingelheim (BI) has broken ground on a new EUR 285-million ($313-million) chemical innovation plant at its headquarters in Ingelheim, Germany.
Starting in 2026, the facility will develop manufacturing processes for active pharmaceutical ingredients and produce drugs for use in clinical trial phases. The building will cover 11,500 square meters on seven floors.
Source: Boehringer Ingelheim
FDA Issues Complete Response Letter to Ascendis Pharma for Mfg Issues
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) related to manufacturing issues to Ascendis Pharma, a Hellerup, Denmark-based bio/pharmaceutical company, for the company’s new drug application (NDA) for TransCon PTH (palopegteriparatide), a drug for treating hypoparathyroidism. In the CRL, the FDA cited concerns related to the manufacturing control strategy for the variability of delivered doses in the TransCon PTH drug/device combination product. The FDA did not express concern about the clinical data submitted as part of the NDA package.
Source: Ascendis Pharma
Fusion Pharmaceuticals Opens Radiopharmaceutical Mfg Facility
Fusion Pharmaceuticals, a Hamilton, Ontario, Canada-based clinical-stage oncology company, has opened a new radiopharmaceutical manufacturing facility. The 27,000-square-foot GMP compliant facility, which is located adjacent to the company’s R&D labs, has clinical- and commercial-scale capabilities designed to support the company’s pipeline of targeted alpha therapies (TATs).
The new manufacturing facility, part of a 15-year lease agreement with Hamilton, Ontario-based McMaster University, was built by McMaster and equipped and validated by Fusion. At full capacity, the facility is expected to produce more than 100,000 doses of TATs per year.
Source: Fusion Pharmaceuticals