Manufacturing

Bristol-Myers Squibb Company (BMS, New York, NY) selected Devens, Massachusetts as the site for its new, large-scale, multiproduct bulk biologics facility.

China?s State Food and Drug Administration (SFDA, Beijing, China) issued a notice on May 18, 2006, requiring drug regulatory departments of provinces, autonomous regions, and municipalities to further strengthen the supervision and management of drug manufacturers.

Schering-Plough Corporation (Kenilworth, NJ) announced plans to phase out manufacturing operations at its Manati, Puerto Rico site, expecting to discontinue operations there by the end of 2006.

On May 26, AstraZeneca (Wilmington, DE) announced it would invest $100 million in research and development in China over the next three years.

I always suspected that our purchasing manager had agreed to this just to save money . . .

Thermal effusivity and power consumption may help predict granulation end point in high-shear granulators. In this study, power consumption was monitored and compared with percent relative standard deviation (RSD) on thermal effusivity measured at-line. Lactose monohydrate, microcrystalline cellulose, and magnesium oxide were granulated, and the effect of load size on granule growth in a fixed-volume granulator was evaluated using three load levels. Load size, liquid addition rate, and impeller speed were measured, and the correlation among RSD on effusivity, power consumption, mean granule specific surface area, and granule compressibility index were determined.

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Interphex provided an opportunity to examine the latest pharmaceutical packaging concepts and packaging machines.

The biggest single recent trend in outsourcing solid-dosage processing has been the movement toward discovery and synthesis of more potent active pharmaceutical ingredients.

ORA leadership looks to staff redeployment and risk management to ensure product quality despite diminishing resources.

The construction of a new oral solid form (OSF) plant is an important decision and a real challenge. The team in charge of the basic conceptual design has to ensure that the new plant will be up-to-date and efficient not only at start-up, but for the next 15–20 years. This means that the project must be able to adjust to capacity changes, product changes and technology changes. It sometimes seems like an impossible challenge.

The first part of this article discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1 This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.

This column provides a summary of the key trends that are occurring within pharma–biotech alliances, as well as looking at biotech–biotech. It will explore the changing balance of power in pharma and biotech deals, providing examples and insights into which areas alliances are becoming increasingly popular.

Bioequivalence with the reference product is the only reliable measure of demonstrating the therapeutic equivalence of a generic product to the innovator product. Systematic and comprehensive innovator product characterization can be used to make generic product development easier. This involves characterization of API and quantification of the critical excipients. The latter contributes towards performance of the final dosage form. This article describes the capsule formulation of a poorly water-soluble drug, celecoxib, which contains sodium lauryl sulphate as a critical excipient. The importance of a decoding process aimed at developing a generic product that matches the innovator formulation in a discriminating dissolution method is demonstrated.

Xethanol Corporation's (New York, NY) subsidiary CoastalXethanol signed a letter of intent with Pfizer Inc. (New York, NY) to purchase Pfizer's pharmaceutical manufacturing complex in Augusta, Georgia.

Rutgers, the state university of New Jersey (New Brunswick, NJ), the New Jersey Institute of Technology (Newark, NJ), Purdue University (West Lafayette, IN), and the University of Puerto Rico (Mayag?ez, PR) won a $15-million, five-year grant from the National Science Foundation (Arlington, VA) to improve the manufacturing of pharmaceuticals, food, and agricultural products.

Roche (Basel, Switzerland) has entered into a nonexclusive agreement with Aspen Pharmacare (Port Elizabeth, South Africa) to speed up production and supply of a generic version of oseltamivir ("Tamiflu") for Africa.

Merck & Co Inc. (Whitehouse Station, NJ) has agreed to acquire two biologics companies: GlycoFi Inc. (Lebanon, NH), a specialist in yeast glycoengineering for $400 million, and the biopharmaceutical company Abmaxis Inc. (Santa Clara, CA) for $80 million.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).

The US Food and Drug Administration?s (Rockville, MD) Center for Drug Evaluation and Research (CDER) received 637 commercial investigational new drug (IND) applications in 2005, a 20-year high.

Bringing Exubera to market requires extensive collaboration by Pfizer, Nektar Therapeutics, West Pharmaceutical Services Tech Group, and Bespak.

China's State Food and Drug Administration prepares to strengthen the enforcement of good manufacturing practices.

With single-enantiomer separations dominating the blockbuster charts, simulated moving bed chromatography and other multicolumn continuous chromatographic processes offer a quick route to clinical trial materials, along with the resolution, economy, and scalability to support tons-per-year production.

Manufacturing and formulation innovation spurs drug develop-ment, but raises new safety and quality issues.

With all the challenges that the manufacturing industry has had to deal with over the last ten years - growing compliance demands, increased competition and price pressures - it is perhaps not surprising that pharmaceutical firms are increasingly trying to streamline their manufacturing processes to maintain profit margins, speed up the time-to-market, as well as comply with market regulations that are becoming increasingly stringent.

The evolution of sophisticated monitoring systems has been accelerated because of stringent EU legislation surrounding the pharmaceutical industry and the escalating demand for preventative maintenance techniques. This article gives an overview of the benefits of implementing these systems in pharmaceutical manufacturing.

Any aseptic processing technology that allows intervention by gowned personnel during operation cannot be considered an advanced technology. Although a standardized definition of restricted access barrier systems has been developed, these systems fall well short of being classfied as advanced technologies.

The author explores the importance of the proposals to revise Annex 1 of the EU GMPs in the context of the desire for science-based, internationally respected GMPs. Commentary also is provided about the relationship between this annex and CEN–ISO cleanroom standards.

Model organisms are useful when validating sterile filtration, but successful retention of the model organism does not always guarantee that effluent is sterile. The authors explore the various factors that influence sterile filtration.