Agnes Shanley

Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the November 2018 US Drug Supply Chain Security Act serialization deadline.

A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.

Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.

Internet of Things, advanced analytics, and blockchain solutions such as smart contracts promise to give manufacturers more control over products and supply chains.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

Continuous downstream bioprocessing is proving its worth, but connecting different operations and integrating upstream remains a challenge.

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.