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

director of Scientific Writing and Regulatory Affairs at Sciformix Corporation

Articles

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

Implementing FDA’s Electronic Labeling Proposal

Contract development and manufacturing organizations join forces to address legislative, regulatory, and business concerns in the Pharma & Biopharma Outsourcing Association.

A Voice of Their Own

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.

What if the expanding pipeline isn’t enough to fuel CMO growth?

What’s Next for the CMO Industry?

Agnes Shanley is senior editor of Pharmaceutical Technology.

Driven by competitive pressures and using models pioneered in other industries, pharmaceutical companies are extending collaboration efforts well beyond their walls.

Opening Up Pharma Innovation

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Handling HPAPIs: Do Your CMOs Have the Right Stuff?

After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.

Moving On to Implementation for Elemental Impurities Testing

Cloud computing has made it easier for pharma companies and their contract partners to gain visibility into their combined supply chains.

Multiple Partners, One Supply Chain

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Industry Viewpoints: Can Sterile Manufacturing Turn the Ship Around?

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Recovering the Value of Repurposed Drugs

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.