Susan Haigney

Process validation is an extension of biologics development processes.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

Communication and taking the time to develop the process are key to successful transfer and scale up of biologics

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

John Ward, vice-president of Engineering at Patheon, discusses the potential for cross contamination in the manufacture of biopharmaceuticals.

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies about automating processes in upstream processing.

BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.

Industry experts discuss what the outsourcing market holds for 2016.

Industry experts discuss the development of process chromatography in bioprocessing.

Industry experts discuss challenges, trends, and innovations in fluid handling.

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design

Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

Congress Passes Generic Drug Act

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

FDA Updates List of Warning Letters

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

The National Institutes of Health have gained the participation of Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, and Sanofi in their effort to advance new therapeutic research.