Development

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

Merck KGaA fill-finish expansion in Italy will be completed in 2017.

The Pediatric Clinical Research Group initiative expands to include pediatric research sites.

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

HHS plan makes progress in ensuring availability of safe vaccines.

Design of experiment is a powerful development tool for method characterization and method validation.

The targeted delivery of cytotoxic drugs using antibody drug conjugates would not be possible without effective linkers to connect and then release the key chemical and biological materials.

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

NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes.

Genmab enters collaboration with Eli Lilly to use and evaluate Genmab's DuoBody technology for bispecific antibodies.

Antibody fragments pose unique challenges in recovery, purification, and formulation.

Clinical-stage biopharmaceutical company Ambrx leverages its site-specific bioconjugation technology through partnerships.

Merck Serono fuels innovation with an integrated research, development, and manufacturing program and seed funding for startups.

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

A new report details FDA's role and responsibilities in personalized medicine.

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

USP is developing and revising distribution standards in response to changes in the global supply chain.

The authors discuss how to develop a cost-effective thermally protective packaging system.