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Roles and Responsibilities of Specialized Clinical Supply Experts

PharmaTech

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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Novel two-chamber setup could predict HPAPI dustiness

European Pharmaceutical Review

Processes in pharmaceutical manufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The researchers highlighted that the risks of hazard exposure include danger to the health of operators and cross-contaminations during manufacturing.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Providing ‘how to’ videos and wikis available at the point of use for the system, rather than relying on distributing printouts of long and complex written standard operating procedures (SOPs). Lorrie is leader of the GAMP laboratory Special Interest Group and Co-Chair of the GAMP Data Integrity Special Interest Group.

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Self-Regulating Footwear for Diabetic Foot Issues

Medgadget

Researchers at the Indian Institute of Science created footwear that can self-regulate the pressure distribution when a person walks, helping to avoid pain and friction that can lead to issues for people with diabetes. Over time, this can lead to issues such as foot ulcers, which can be particularly bad because of the underlying diabetes.

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Making the Case for Case Management for Cell and Gene Therapies

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. It is crucial to ensure supply chain risks are mitigated and have proactive strategies in place to address unforeseen challenges before they become an issue.

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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective 

Pharmaceutical Technology

CGT trials operate with much lower volumes of manufactured final product. CGT have highly unique and specialized manufacturing processes. This implies precise (and frequently changing) timeline planning for drug manufacture and delivery. This is a primary factor for the staggeringly high unit cost of CGT.

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Leading pharmaceutical wholesalers

Pharmaceutical Technology

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. GDP and GMP advisory.

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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.