Quality/GMPs

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.

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

A QbD paradigm advances process understanding in development and manufacturing.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

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.

The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi's six-in-one pediatric vaccine for marketing authorization.

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

Shortages spur efforts to overhaul manufacturing oversight.

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

Project: transfer a manual concentration/diafiltration process for siRNA production.

Eastern Europe is moving towards a goal of harmonized regulations.

Improvement strategy should be linked to business strategy.

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

Additional approvals in December have helped to outpace a recent high set in 2011.

FDA talks about the changing scope of regulatory science.

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

Shortages spur efforts to overhaul manufacturing oversight.

The EU fine-tunes the Falsified Medicines Directive.

What the industry's future holds and what needs to be done to get there.

Neil Lewis, chief technology officer at Malvern Instruments, talks about the challenges associated with biologics.

A recent ISPE guidance provides a baseline for the design of quality laboratory facilities.

The management board of the European Medicines Agency (EMA) has endorsed the agency?s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

Mylan Inc. has issued a recall of three lots of the painkiller tablets, hydrocodone bitartrate and acetaminophen, USP 10 mg/500 mg, due to the potential risk that these lots (lots 3037841, 3040859 and 3042573) may exceed the potency stated on the label.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

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

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.