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France's Orano Med debuts radiotherapy manufacturing plant near Indianapolis

Fierce Pharma

to establish a manufacturing plant as it progresses on its radiopharma journey. Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana.

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FDA cracks down on China's Hengrui in scathing manufacturing write-up

Fierce Pharma

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |

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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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Thermo Fisher plots layoffs at California plasmid manufacturing site as demand swings

Fierce Pharma

Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping b | Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than (..)

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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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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

What are the top three challenges associated with gene therapy manufacturing? Manufacturing of AAV vectors for gene therapy presents several significant challenges, such as: Scalability : AAV production often involves complex biological processes that are difficult to scale without compromising quality and yield.

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AstraZeneca places $1.5B bet on end-to-end ADC manufacturing in Singapore

Fierce Pharma

Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan this winter—AstraZeneca is placing a b | Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan (..)

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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.