Outsourcing

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

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

As payers refuse to cover new drugs, CMOs take a hit.

Aesica Pharmaceuticals S.r.I. collaborates with QAD to meet China's Food and Drug Administration's shortened serialization deadline.

With budgets growing, clients see CMOs' costs as less crucial.

Evolving clinical trial research services give biopharmaceutical companies options for full- and functional-services.

Biopharma companies should not overlook India's growing market.

The CMO industry's value proposition is limiting its market penetration.

Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.

Vetter launches new serialization process to support track-and-trace efforts.

Changes in company ownership shake up the CMO industry.

Thirteen companies are accepted for participation in the supply chain program.

CMOs may find opportunities in alternative expression services.

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

The R&D model is in transition and creating new demands on contract services providers.

Partnering with CDMOs can help bridge the innovation gap.

Ongoing changes create new opportunities for CROs and CMOs.

Almac releases an enhanced third-party logistics customer billing application.

Lyra Myers, associate director and value creation agent at Roche, has been elected DCAT president.

ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

Data from BioPlan Associates' 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

Practicality of implementation should be a part of vision in the bio/pharmaceutical industry.

Through its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.

Are strategic partnerships in clinical research a model for CMC services?

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

The report highlights a need for greater third party certification to ensure GMP vigilance.

Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.

The facility, which includes state-of-the-art formulation, analytical and synthetic laboratories as well as a customer training center, will focus on bioavailability enhancement and oral dosage formulations.

The industry may not be ready for India and China as regulatory issues emerge.