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Pharmaceutical Manufacturing and Packing Sourcer

Industry Insight


Jonathan Blamey at DHL Supply Chain asks an important question: “a reliable supply chain can make or break the success of a clinical trial, but why isn’t maximising efficiency a focus for many pharmaceutical companies?” (page 78). One might include CROs as well. Perhaps the supply chain might not be considered a hugely important factor in clinical trials; managers tend to concentrate on recruitment as the rate-determining step in completion of the trial. However, when you start to consider the huge costs involved in moving investigational medicines across the globe, and the need to account for all returns to complete the trial, it is possible to appreciate how a supply chain that isn’t operating at maximum efficiency can result in clinical trials taking longer and costing more than necessary.

James Wright and Andrew Partis at PA Consulting Group discuss some of these difficulties in their contribution to this issue (page 108). They contend that today’s pharmaceutical supply chains tend to be slow to react, high in inventory and often pursue a ‘one-size-fits-all’ approach. Parts of them are often regionally managed, even where unnecessary, leading to different approaches and speeds of adoption of innovation. Therefore, they can be slow to optimise and as a result, significant performance improvement is not sustained, as business requirements continue to move too quickly. In addition, it is essential to design supply chains that are driven by market need rather than by legacy arrangements, and not to be afraid to re-design them as markets evolve.

If your supply chain is not efficient – never mind optimised – it puts a strain on the supply of product to clinical trial sites. These products are experimental by their very nature and it may well be that their packaging is sub-optimal, and moreover may itself be undergoing evaluation and optimisation. Michael Lock at Smithers Rapra discusses the issue of plastic packaging, pointing out that in order to achieve product performance, product validation and shelf life it is important to consider the nature of primary packaging and explore appropriate plastics material selection (page 100). Indeed, the consequences of inappropriate selection can ultimately be product failure, and prove to be very costly.

A particular challenge to packaging a product for consumption may lie in cutting-edge formulations. One such challenge is discussed by Scott D Barnhart at ARx, LLC (page 37). He highlights oral thin film technology, which offers formulation flexibility and can naturally transition to transmucosal delivery applications. The benefits of dissolvable film technology include fast, accurate dosing in a safe, efficacious format that offers convenience for the patient and caregiver alike. Looking forward, the use of micronised and nano-particle APIs in a film can open the door for potentially more effective drug delivery methods.

I only have space to highlight a selection of the interesting articles in this rich edition of PMPS but would finish with a warning that I received in my email the other day. “Be prepared. The FDA is just weeks away from having broad new authority to oversee and enforce pharma and device supplier quality. FDA inspectors are already asking to see manufacturers’ lists of approved suppliers and those demands will only get tougher. Congress is pushing pharma supplier agreements to the top of FDA’s to-do list. Pharma supplier audits are also likely to be required soon.” Manufacturers and CMOs should ignore these warnings at their peril.

And Finally

As this issue goes to press, PMPS is already looking ahead to the autumn’s major events. The line-up kicks off with ICSE/CPhI/P-MEC in Madrid, from 9th-11th October. The world’s top pharmaceutical CMOs, packaging organisations and formulation specialists will be on show, promoting their latest ideas – and as a sponsor of the ICSE Speaker’s Corner, PMPS will be taking a front seat. You can catch us in Madrid, or if you’d like to know more, do get in touch.

In November, the focus will be on logistics, with some essential insights on how to maximise supply chain performance and connect more effectively with your cool chain provider. We’ll also be considering supply chain sustainability and the measures the industry is currently looking at to tackle a growing issue. Of course, if there’s anything else you’d like to see covered, feel free to email me: chrisb@samedanltd.com. Enjoy the read.

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Graham Hughes
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Chris Baker
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