Manufacturing

Roche (Basel) launched a groupwide operational-excellence initiative intended to modify the company's cost structures and accelerate its productivity improvements.

After hosting the first international scientific workshop on nanomedicines earlier this month, the European Medicines Agency (EMA) has concluded that further research is needed to provide an adequate scientific basis for evaluating the quality, safety, and efficacy of such medicines.

The Society for Chemical Manufacturers and Affiliates (SOCMA) issued recommendations relating to disclosure of confidential business information (CBI) in response to Environmental Protection Agency's (EPA) decision to limit CBI claims on chemical identity under the Toxic Substances Control Act (TSCA).

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasized the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonized, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline's pandemic influenza vaccine Pandemrix to investigate whether there is a link between vaccination and cases of narcolepsy, a rare sleep disorder.

Editors' picks of pharmaceutical science and technology innovations.

Weighing the pros and cons of REMS for bringing risky products to market.

Company and People Notes: Lonza Acquired Vivante; PPD Appoints VP of Quality Management; And More.

The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data for scaling up a project.

Industry efforts toward global healthcare surpass average expectations.

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.

Pending legislation may give FTC the authority to regulate all Hatch-Waxman settlements.

Pharmaceutical Technology gains insight into approaches for producing aromatic amines.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

Software and online monitoring are helping the pharmaceutical industry improve its corrective and preventive action programs. This article contains bonus online material.

PharmTech talked to anticounterfeiting experts to discuss terrorism as a source of counterfeit products.

Industry participation is crucial as USP embarks on far-reaching monograph modernization initiative. This is an online-exclusive article.

New data provide insight into pharma-industry professionals' daily lives.

In the final article of a three-part series, the authors discuss how to present a design space and evaluate its graphical representation.

The President's Council on Advisors on Science and Technology (PCAST), a group administered by the federal Office of Science and Technology Policy (OSTP), issued recommendations to improve the country's ability to accelerate vaccine production and delivery in the event of a pandemic flu outbreak.

Genzyme (Cambridge, MA) confirmed that it had received sanofi-aventis's (Paris) proposal to acquire all of its outstanding shares for $69 each.

A Strengths, Weaknesses, Opportunities and Threats analysis of the biosimilars market is given.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

Despite the poor economic climate, large-scale mergers and acquisitions in the pharmaceutical industry struck back with a vengeance in 2009.

Bristol-Myers Squibb's fit-for-purpose mode for clinical-trial materials for early-stage development seeks to achieve a better way in resource allocation. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

The current trend in the pharmaceutical industry for the manufacture of small-molecule therapeutic agents is moving toward continuous flow processes. This article is part of a special issue on APIs.

In an increasingly competitive landscape, outsourcing providers are under mounting pressure to get their name out there and secure new and repeat business.

The author presents recent developments in simulated moving-bed chromatography in production of active pharmaceutical ingredients and intermediates. This article is part of a special issue on APIs.

The author explains the background behind the excipient pedigree and how to implement its use.

Every biopharmaceutical is unique and products are defined as much by their manufacturing process as their analytical characterisation. Because of this, the development of biologics has many inherent complexities over small molecule projects.