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Though largely operating in the background until recently, Prolific Machines’ optogenetic approach to biomanufacturing is set to make waves thanks to the achievement of an impressive milestone in monoclonal antibody manufacturing.

The company chalks up a financial impact of about 150 billion Korean won ($102 million) from “preemptive production adjustments” made to mitigate potential manufacturing impacts, a spokesperson said.

After topping up its long-running operations in Puerto Rico last year, Amgen is infusing $300 million more into the U.S. territory.

The company looks to achieve an “amicable resolution as soon as possible” and is focused on minimizing disruption to its operations, a spokesperson said in an emailed statement.

Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when replying to the

Amarox, the U.K. unit of India’s Hetero Group, issued a voluntary recall of one batch of sertraline tablets in Britain after a patient found two different antidepressants packaged together.

Novartis will construct an active pharmaceutical ingredient (API) facility in Morrisville, North Carolina, the company said Thursday. The 56,200 square-foot plant will manufacture compounds for solid-dose tablets, capsules and RNA therapeutics.

After recalibrating its production strategy in the late 2010s to help meet the realities of the CAR-T market, Gilead Sciences’ Kite Pharma is preparing to hit the ground running with the potential

During Pfizer’s right-sizing push after the COVID-19 pandemic, the company’s multibillion-dollar cost-cutting campaign has affected its Ireland operations in several ways. Now, more employees in the country are set to lose their