Contract Manufacturing, Biopharmaceutical Production

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.

There are significant differences between small molecules and biologics fill/finish capacity.

A dynamic market, industry consolidation, and demand fluctuations lead to a mixed picture of pricing results.

Representatives of contract service organizations discuss technology trends with BioPharm International.

The author highlights the top 10 outsourcing trends found during a survey of biopharmaceutical manufacturers.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

Successful management of the CMO/client relationship should include open communication and trust.

Will international biomanufacturing outsourcing become mainstream in this decade?

The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."

Measuring the size of the market for contract manufacturing services requires a careful hand.

Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.

Industry wants more innovation, but can suppliers meet customers' needs?

Industry experts discuss significant achievements. Plus: What's in store for the future.

Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.

Industry optimism is on the rise for 2012.

Industrializing design, development, and manufacturing of therapeutic proteins.

China rises to the top as a destination for international outsourcing.

The authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.

Formulation strategy is an important consideration when selecting and managing outsourced biopharmaceutical development programs.

Partner with a contract manufacturing organization that integrates best practices from project management, customer service, and Lean.

Collaborations between Western and Indian companies may provide the best path for offshoring successfully and for developing India's readiness.

"A systematic approach taken by a company involved making an assessment of internal capabilities, strengths, and needs before the selection process."

How to ensure smooth technology transfers.

There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.

The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.

After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.

When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.

A CMO faces significant risk of lost revenues and profits if the product fails in clinical trials or doesn't meet sales projections.