Pharmaceutical Technology Europe-06-01-2006

Pharmaceutical Technology Europe

Evolving concepts in plant design: part 1

June 01, 2006

Facilities

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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.

A guide for testing biopharmaceuticals Part II: acceptance criteria and analytical method maintenance

June 01, 2006

Biopharmaceuticals

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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.

Generating and protecting knowledge with electronic laboratory notebooks

June 01, 2006

IT

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In the face of spiralling R&D costs, currently estimated at $800 million to produce a new drug, the discovery industry is constantly searching for ways to keep expenditure low, increase productivity and meet ever-stricter guidelines imposed by regulatory bodies.

Spotlight

June 01, 2006

Spotlight

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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.

Criticality of functional excipients and decoding methods during generic product development

June 01, 2006

Chemicals and Raw Materials

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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.