Manufacturing

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.

As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

This article is part of a Special Report on the Emerging Markets of The East, October 2009

Pharmaceutical companies get ideas for sustainable packaging from other industries.

The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.

Jeff Robertson talks about a unique form of micro-tag technology that can be applied to solid dose pharmaceuticals.

Even though the pharmaceutical industry has come to recognize the importance and associated benefits of using computers, evolving computer-based simulation technology has still to make a suitable impression.

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of protein.

A new report evaluating the biotechnology sector in new European Union member states and candidate countries has described biotech developments as "uneven" because of contrasting economic strategies in different countries.

Formoterol presents formulators and manufacturers in the asthma and chronic obstructive pulmonary disease marketplace many challenges.

The biopharmaceutical company Seattle Genetics (Bothell, WA) introduced a sugar-engineered antibody (SEA) technology that is designed to increase the potency of monoclonal antibodies through enhanced effector function.

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.

Company and People Notes: Boehringer Ingelheim will acquire Wyeth's animal health business; Amsterdam Molecular Therapeutics appoints CEO; more...

Julian Mosquera, Director of LCP Consulting, advises how pharma companies can make their supply chains leaner.

Sophie Walton, Business Manager at CPI UK explains how Centre for Process Innovation (CPI) UK partners with industry to promote microreactor technology (MRT).

Microreactor technology (MRT) has recently been introduced to the pharmaceutical manufacturing circuit as a promising technology for the continuous processing of commercial quantities of pharmaceuticals.

Despite the economic downturn, Spain's pharmaceutical industry continues to grow - particularly when it comes to biotechnology.

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

Abbott Laboratories (Abbott Park, IL) agreed to acquire the pharmaceutical business of the Solvay Group (Brussels, Belgium) for EUR 4.5 billion ($6.6 billion) in cash, according to an Abbott press release.

Vetter (Germany) is intending to open a technologically advanced customer services facility at the end of 2009 in Chicago (US).

While pharma is not synchronized with the boom and bust of the general economy, lessons from the business cycle facing manufacturers can enable the pharmaceutical industry to tackle the problems it faces.

The Gerresheimer Group is opening two new centres: an R&D center for medical plastic systems in the US and a new production center for pharmaceutical plastic packaging in Spain.

A joint venture between a charity and a pharma giant has led to the creation of the Hilleman Laboratories, which will use a not-for-profit operating model to develop and deliver vaccines to low-income countries.

A report from the European Medicines Agency (EMEA) has highlighted the critical fact that there are not enough new antibiotics in the pharmaceutical industry's pipeline to fight multidrug-resistant bacteria.

Many pharmaceutical companies in the United Kingdom are turning to basic business-skills training to help them emerge from the recession stronger than before.

Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more...

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

Semisolid Formulation Development: The CRO Approach - SP Formulations Whitepaper

The FDA has approved four vaccines for the H1N1 influenza virus, while other companies, including UK pharma giant GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.