Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market.

Pharmaceutical Outsourcing Present and Future

The need for preclinical testing expertise is growing as molecular complexity increases.

Navigating the Preclinical CRO Outsourcing Process

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

A Closer Look at Affinity Ligands

Topic

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

Articles

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

Agnes Shanley is senior editor of Pharmaceutical Technology.

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

Selecting the best partner contract service and fostering a successful relationship requires detailed research and effective communication.

What Works Best in Pharma-CRO Relationships?

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

The Digital Supply Chain: Seizing Pharma’s Untapped Opportunity

Charlotte Hicks is an independent supply chain management and risk consultant based in Raleigh, NC.

Supply chain risk monitoring is crucial for any company doing business today, and it doesn’t have to be expensive.

Zero Budget Supply Chain Risk-Monitoring and Mitigation

Mike Jovanis is the vice president of product management at Sparta Systems

More life-sciences companies are starting to manage global suppliers holistically.

Getting, and Staying, Ahead of Global Quality Demands

Philip Lienbacher is head manager of raw material policy ownership at Shire, Vienna.

Manfred Karner is head of material lifecycle management at Shire, Vienna.

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.

Collaborating for Efficiency and Safety in Raw Material Inspection

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.