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Manufacturing

 

Informatics: The use of LIMS in the management of translational research and pilot manufacturing operations

22 October 2013 | By Diana Russom (Department of Information Technology Systems, Beckman Research Institute of the City of Hope) / Amira Ahmed and Nancy Gonzalez (Laboratory for Cellular Medicine, Beckman Research Institute of the City of Hope) / David L. DiGiusto (Laboratory for Cellular Medicine and Department of Virology, Beckman Research Institute of the City of Hope)

The volume of data generated in modern medical research centres is growing exponentially and becoming more diverse as advancements in automation and biotechnology transform the basic operations of these laboratories and clinics. Patient care and laboratory instrumentation generate data at a rate that rapidly outpaces the ability to track and…

Towards the real application of rapid microbiological methods in developing countries

22 October 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and Suzan Mohammed Ragheb, Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries

Rapid microbiological methods (RMM) have gained popularity and acceptance within a number of industry sectors, including food and beverages, diagnostics, environmental, personal care and pharmaceuticals. In recent years, many firms have successfully validated and implemented RMMs for a wide variety of applications. However, many geographic areas around the world still…

Six Sigma: How Rottapharm is using Lean Six Sigma principles

20 August 2013 | By Richard Hayes, Continuous Improvement Manager, Rottapharm

From their headquarters based in Monza, Italy, Rottapharm’s long history of success began in 1961 with the creation of a small laboratory for independent research. The company from its early beginning has continuously invested in research, innovation and development of pharmaceutical products for distribution on a worldwide scale. After acquiring…

The Encyclopedia of Rapid Microbiological Methods: The new fourth volume discusses technologies, regulatory acceptance and validation case studies

13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com

This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…

Current activities of the USP Microbiology Expert Committee

18 April 2013 | By Radhakrishna S. Tirumalai

For sterile as well as nonsterile pharmaceutical products, manufacturers must eliminate or minimise potential risks to patients as well as product quality. While many contributing factors may affect the quality of a medicine or its ingredients, microbial contamination control and proper sterilisation methods are critical considerations for the manufacturer throughout…

A pragmatic approach for the adoption of QbD principles for analytical method development and validation

18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG

The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…

The central role of excipients in drug formulation

18 April 2013 | By Pascal Furrer, Pharmacist

Active substances are rarely administered alone. For example, levothyroxine, a synthetic form of the thyroid hormone, indicated in the treatment of hypothyroidism, is administered at a very low dosage, ranging from 15 μg to 200 μg. These very small amounts of powder mean that it is not possible to manufacture…