Mfg News: Intellia and Mallincrodkt

A roundup of manufacturing news from Intellia and Mallincrodkt.

Intellia To Build Mfg Facility for CRISPR-Based Therapies
Intellia Therapeutics, a Cambridge, Massachusetts-based genome-editing company, has entered into a lease agreement to develop a 140,000-square-foot manufacturing facility in Waltham, Massachusetts to support the manufacturing of key components for its CRISPR-based investigational therapies.

The new manufacturing facility will support preclinical through commercial supply upon regulatory approval. The new facility is expected to be operational in 2024.

Source: Intellia Therapeutics

Mallincrodkt Gets FDA CRL for Mfg Issue
The US Food and Drug Administration (FDA) has issued a Complete Response letter (CRL) to Mallincrodkt regarding the timing of an inspection for terlipressin, an investigational drug to treat adults with hepatorenal syndrome (HRS), a disease that reduces kidney function. Lilly had earlier submitted a new drug application (NDA) for the drug and the drug is under review by the FDA.

Mallincrodkt reported that within the last two weeks (as reported on February 22, 2022), it became necessary to identify a new packaging and labeling manufacturing facility for the drug, which meant that an inspection of the new facility by the FDA could not be completed by the FDA target date under the Prescription Drug User Fee Act. A satisfactory inspection is required before the NDA can be approved. The company says this is the only outstanding issue noted in the CRL; there were no safety of efficacy issues.

Mallincrodkt says it believes that there is a path to approval for the drug in 2022.

Source: Mallincrodkt