Development

FDA publishes guidance on ANDA submissions.

EMA releases details of restructuring.

EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.

FDA updates guidance to reflect advances in technology.

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

Novasep's Sius single-use tangential flow filtration skid offers a 100% single-use TFF solution.

EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.

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

A new end-user survey of more than 220 physicians and 650 patients by Frost & Sullivan finds that regardless of disease area, physicians select drug delivery methods that drive consistent patient compliance and effective outcomes.

Almac's Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products.

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.

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.