samedan logo
 
 
spacer
home > pmps > autumn 2007 > cool runnings
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Cool Runnings

Robert Kayum at Kuehne+Nagel outlines the novel possibilities offered by future temperate chain shipping solutions

THE CURRENT CLIMATE

Key drivers in recent years within the pharmaceutical and healthcare sectors relating to temperature-sensitive APIs and finished products include:

  • Growth of temperature-sensitive products from R&D to marketplace
  • Increasing focus by regulatory authorities
  • Broader guidelines/regulations
  • Increased media focus
  • The need to deliver complete, integrated solutions for the purpose of the customer

One significant change within recent years has been an increasing focus on temperate products; the MHRA aptly stated that “30 per cent of serious GDP deficiencies during 2004 and 2005 related to storage and transportation of medicines other than cold chain products”, raising the question, what are these products types and why? The correct definition coined by the MHRA is as follows: “temperate chain distribution refers to storage and transportation of products that are chemically and physically stable between +15 and +30°C, with occasional excursions permitted to +35°C”. The reasoning behind such stability is that major time and temperature excursions beyond these ranges leads to separation, change in crystalline structure, sedimentation of active ingredients and reduced product shelf life (1). Products within this range can include anaesthetics, oncology products, eye drops, selective serotonin reuptake inhibitors (SSRIs) and antibiotics.

Another crucial point to mention that reinforces the need for the increasing spotlight on products within this range is that medicines with a combined worth of $65 billion currently stand to lose patent protection within two years and will be taken up by Indian generic manufacturers, who are currently pushing through patent challenges (2). Furthermore it has been reported that the NHS would make considerable savings amounting to several billion pounds by switching, where possible, to cheaper generic versions of drugs whose patents have or are due to expire.


Read full article >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
5
     

There are no comments in regards to this article.

spacer
Robert Kayum is Head of Cold Chain Compliance at Kuehne+Nagel. He originally started working within the cold chain sector 17 years ago for Laminar Medica UK Ltd, where he gained invaluable experience in manufacturing, product development and validation. In more recent times, Robert supported Softbox Systems and their partner DHL through the provision of value added consultancy. This lead to Robert acting as an external, Cold Chain Consultant to companies such as Kuehne+Nagel, BMI and DHL prior to joining Kuehne+Nagel at the start of 2007. Robert is part of IATA’s Perishables Board, has recently been inducted into the International Who’s Who Historical Society of Professionals and is a member of the editorial board for the International Pharmaceutical journal.
spacer
Robert Kayum
spacer
spacer
Print this page
Send to a friend
Privacy statement

Industry Events

EMBALLAGE 2008. World Packaging Exhibition

16-21 November 2008, Paris-Nord Villepinte - France

“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
More info >>

 
News and Press Releases

MipTec, October 14 – 16, 2008, Switzerland

MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com    
More info >>

 

©2000-2007 Samedan Ltd.
About Us | Register | Login | Site Map | Terms and Conditions | Contact Us |
Add to favourites

Print this page

Send to a friend
Privacy statement