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Leading clinical packaging companies in contract marketing

Pharmaceutical Technology

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.

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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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Why demand is rising for secure and climate-controlled gene therapy services

Pharmaceutical Technology

“Cell and gene therapies are not your typical clinical supply chain. It’s much more complex and it has to be 100% correct, or else patients are really at risk,” explains Michael MacNeir, vice president of Business Development, Sharp Clinical. The requirements When handling personalised medicines, time is of the essence.

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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia.

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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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Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities

The Pharma Data

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. at the BioProcess International Theater.

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Top 5 Dos and Don’ts of RTSM 

VirTrial

Do consider the impact of decisions A lot of decisions get made during the design of a clinical trial; be they decisions on data or packaging and distribution design. Don’t involve RTSM too late If it’s beneficial to involve RTSM early , then conversely, it’s a bad thing to leave RTSM development until closer to FPI.