Publications
Leachables and Extractables Affect Single-Use and Disposable Systems
By Nigel J. Smart PhD, Managing Partner, Smart Consulting Group
Published on PharmaQuality.com in their April/May 2012 Issue
Take steps to limit undesirable effects
Leachables and extractables have become a significant driver in the potential application of single-use and disposable systems. The increase in industry activity associated with these systems and products reflects their perceived relevance and importance for biopharmaceutical drug manufacturing.
Issues connected with the use of leachables and extractables with various plastics and polymers have been discussed for more than 25 years in the pharmaceutical industry, where products have been in widespread use and have been associated with a variety of applications. Many applications have included use in water-based systems such as syringes and various other sealing components, so there is a long history with regulatory authorities such as the FDA.
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Lean Manufacturing:
The role of continuous processing in the pharmaceutical industry
By Nigel J. Smart PhD, Managing Partner, Smart Consulting Group
Pharmaceutical Processing – August 2012
One of the fundamental tenants of lean manufacturing relates to the use of continuous processing as a game changing methodology to replace more traditional batch processing.
At the heart of this philosophy is the basic concept that to reduce individual break points in the manufacturing process reduces the non-added value work components of the process. In reducing these manufacturing breakpoints, many of the seven forms of waste can be eliminated which ultimately has a significant impact on the efficiency of the overall pharmaceutical production process.
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Vaccine Production Using Single-Use Disposable Technology
By Nigel J. Smart PhD, Managing Partner, Smart Consulting Group
Published on PharmPro.com on Tuesday, January 15, 2013
Biotherapeutics require specialized manufacturing approaches when compared to synthetic chemical entities because the process used to synthesize the 3-D structure of the molecule defines its pharmacological activity and its associated value as a medical product. In practice, this involves the culture conditions of the host organism used to express the molecule and potential changes that may occur to the chemistry of the active components during recovery and purification. These changes can include both conformational changes in the structure as well as alterations due to protease and other enzymatic action. In these cases, moieties can be clipped selectively from the tertiary drug skeleton, or changes can occur in the degree of glycosylation due to enzymatic or chemical hydrolysis. Individually and/or collectively these can have a profound effect on the pharmacological activity and bio availability of the drug.
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