Manufacturing

Monica McDonnell is director strategic business development Europe at Informatica.

Articles

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.

The Challenge of IDMP Compliance

Peter Soelkner is Managing Director of Vetter Pharma International GmbH, Germany.

The trends in the year 2017 will present the industry with new challenges, and companies will be able to meet them successfully if they focus on the issues at hand.

Past, Present, and Future Trends Affecting the Bio/Pharmaceutical Industry

Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages

Drug Shortage Survey Points to Pharma’s Supply Chain Management Weaknesses

Agnes Shanley is senior editor of Pharmaceutical Technology.

Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving novel therapies.

Cold Chain: Zeroing In on the Last Mile

An example of a new cold chain temperature-controlled shipping technology is Cocoon, which was commercialized in November 2016 and designed for use with pallet-sized shippers.

Last-mile temperature control

Brian Keesee is Executive Director for North America Operations, PCI Clinical Services.

Cold-chain requirements and the tight logistical windows needed for cell and gene therapies demand a focus on early communication and risk mitigation.

Careful, Early Cold-Chain Planning is Crucial for New Biologics

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.

Preparing an Approach to Cold Chain for Cell- and Tissue-Based Therapies

Staffan Widengren is director of corporate projects at Recipharm and program manager for the Recipharm global serialization project. He has been working as quality director and general manager within the Recipharm Group since 2002.

Many pharmaceutical manufacturers were late in involving contract partners in serialization efforts. Are you ready, and are you working with the right partner?

Serialization: The Final Countdown

Haris Kamal is senior vice-president of Verify Brand.

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.

Serialization Preparation Prompts Data and Business Questions

Currently, pharmaceutical manufacturers are said to waste $25 billion on supply chain inefficiencies. Technology offers a way to achieve transparency and results.