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Pharmaceutical Manufacturing and Packing Sourcer

Industry Insight

I always say that you can judge the standard of a conference by the difficulty you have in choosing which of the sessions to attend. I have found the same difficulty when picking out the articles to highlight in this edition of PMPS. There is so much content I could have discussed here, but I must begin with the article on the Falsified Medicines Directive (FMD) by Simon Slater of Datamere Software Solutions.

For some time now, it has been well known that counterfeit and falsified medicines are a growing problem. This falsification in drug manufacturing is a potential threat to the health of patients, particularly those requiring drugs to treat critical illnesses and also those who ingest drugs with ineffective or illegitimate ingredients. Likewise, it is damaging to pharmaceutical manufacturers.

Slater therefore welcomes the European Commission Directive, which came into effect earlier this year. He hopes that we may see the emergence of an industrywide bespoke system for combating counterfeiting. This would integrate with existing technology within the production process and impact on data management across the board, dealing with counterfeits at an individual packet level until the drug is dispensed.

Perhaps the ultimate method of preventing falsification and counterfeiting of drugs could be personal medicine. Andy Fry and Paul Greenhalgh from Team Consulting ask a simple question: why should drug delivery devices not be personalised? This would surely give the sufferer from asthma or diabetes, for example, more confidence in the drug they are being dispensed.; not to mention the possibilities for tackling the differing cognitive and physical abilities of each patient, which may mean that easier to handle devices, or even packets, may be required.

The authors expect that personalised devices will help ensure the medical condition is better managed, which is beneficial to both patients and the healthcare system. Pharmaceutical companies which market such devices would expect to increase market share and customer retention. Fry and Greenhalgh feel that this is an opportunity to be grasped.

One of the more difficult steps towards personalisation may be in the area of taste, as explored by Amie Gehris and Jon Fisher from The Dow Chemical Company. They note that the majority of orally administered APIs are inherently very bitter, and this is a particular problem with paediatric formulations. With the ability to mask bitter-tasting APIs seen as one of the biggest challenges facing drug formulators today, their interesting paper discusses a variety of approaches to taste-masking, specifically ion-exchange complexation.

Many of those involved in R&D would describe generic drugs as copycat, in a pejorative sense. However, it is only through the use of generic drugs that healthcare can be even remotely affordable. The aforementioned FMD applies not only to patent-protected drugs but also to generic drugs, and will force all APIs used in Europe to be manufactured in accordance with GMP, as explained by Michael Gamlen of Gamlen Tableting. With a similar move taking place in the US, he feels that the quality of generics can only improve in years to come.

I cannot close without drawing your attention to a stimulating article by Heather Fraser from IBM which reports a major survey of 664 supply chain management executives, of whom 33 were from life sciences companies. The survey revealed three significant issues which one might call the three Vs: volatility, visibility and value.

Iím sorry not to have space to bring more attention to articles on cold chain supply, novel packaging materials, and especially Siemensí article on barriers to growth. Thank you to all our contributors Ė I hope you enjoy these articles as much as I did.

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