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Moderna lays off parts of manufacturing team after resizing COVID footprint

Fierce Pharma

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

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Eli Lilly's troubled NJ manufacturing site in hot water again over maintenance, quality control lapses

Fierce Pharma

Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance. Food and Drug Administration’s crosshairs, Reuters first reported.

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Takeda winds down manufacturing and R&D operations in Austria after gene therapy pivot, plots 190 layoffs

Fierce Pharma

After Takeda’s unsuccessful attempt to sell an Austrian manufacturing and development site, the Japan-based company is calling it quits on much of the operations at the facility.

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AGC extends CDMO expansion spree, plans second manufacturing facility in Japan

Fierce Pharma

Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama. Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.

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Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls

Fierce Pharma

When it comes to manufacturing cell therapies, it's often said that the "process is the product." The company says it's working to address the situation.

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Astellas' gastric cancer candidate rejected by FDA because of manufacturing issues

Fierce Pharma

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

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Making the Case for Case Management for Cell and Gene Therapies

A dedicated Case Manager provides end-to-end supply chain management and 24/7 oversight and support to help ensure the seamless manufacturing and distribution of each therapy dose to every patient.