Outsourcing

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers to better secure the pharmaceutical supply chain.

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

Industry groups offered perspectives on the strengths and weaknesses of the European Falsified Medicines Directive.

The investment activity of CDMOs and CMOs reveals the broader business and technical trends of the pharmaceutical industry.

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.

The PharmTech/PharmSource annual outsourcing survey results suggest that CDMOs may be getting complacent.

Increased pharmaceutical trade creates new challenges for regulatory oversight.

Claudia Roth, President of Vetter Development Service USA, discusses trends in single-use technology for clinical manufacturing.

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.

Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.

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

The US and EU move forward with measures to fortify the pharmaceutical supply chain.

Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.

Roberto Darienzo, chief operating officer of Halo Pharmaceutical, describes strategic plans and industry trends.

Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.

A Q&A with Stuart E. Needleman, President and Chief Operating Officer of Aptuit, on recent industry trends.

Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.

Eisai and Biogen Idec pursue an innovative approach to capacity management.

As the strategic value of emerging markets increase, pharmaceutical companies increase their R&D and manufacturing investments.

FDA's requirements for API manufacturers in regards to ICH Q7.

Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.

Is the contract-only CMO an endangered species?

A UC Berkeley survey provides insight into biopharma's risk concerns and strategies.

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry through a combination of acquisitions, partnerships, and select investments.