Development

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

The $1-billion deal includes select parts of Merck?s manufacturing site in Oss, The Netherlands and Sioux City, Iowa as well as 11 finished products.

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

A Q&A with SCHOTT Pharmaceutical Systems and West Pharmaceutical Services

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

Companies can use metrics as a tool to help drive positive change and quality process improvements.

Project will optimize expansion and harvest of human cells in bioreactors.

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

The author presents best practices for extractables and leachables.

Catalent Pharma Solutions has acquired a license to market Redwood Bioscience 's proprietary SMARTag precision protein-chemical engineering technology.

Astellas and Ambrx have entered into a collaboration to discover and develop novel antibody drug conjugates (ADCs) for an undisclosed number of targets in oncology. ADCs enable targeted delivery of drugs to the target tissue.

Have FDA initiatives improved manufacturing quality?

Latin America's diverse growing market seeks regulatory harmonization.

Opioid abuse generates calls for efforts to curb distribution.

Applications of ZFN technology in biopharmaceutical cell-line engineering.

EU authorities are stepping up their efforts to incorporate QbD principles.

This article examines the options to best match needs and spending for quality and regulatory leadership.

The authors present solutions based on a review of current service offerings and their audit experience.

Vaccine development is benefiting from manufacturing advances.

Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

Shortages spur efforts to overhaul manufacturing oversight.

Innovative products and a range of indications drive the therapeutic antibody market.

Therapeutics targeting epigenetic mechanisms of disease will change the pharmaceutical marketplace.