Improving the Security, Quality & Compliance of your Biologic Operation



Pharma IQ
02/21/2012

In the coming years, biologics are expected to make up a greater proportion of revenue growth for pharmaceutical companies, with some figures placing it as high as 60 per cent. 

The US Food and Drug Administration last year approved a total of 24 new molecular entities and six new biologics, the greatest number approved since 2004.

This new batch of drugs includes a number that target unmet medical needs and hit new targets. There are a number of reasons driving this development.

The What You Need to Know About the Follow-On Biologic Market in the US: Implications, Strategies, and Impact report from Thomson Reuters draws attention to the patent cliff and abbreviated approval pathway for biologics as making biologics so attractive.

And this means the development of biologics will be placed under greater scrutiny, enhancing the need for better security, quality and compliance within biologics operations – not least the international transportation on which companies are becoming increasingly reliant.

Updated guidance on good distribution practice from a number of countries across the globe suggests the increasing scrutiny transportation is being placed under.

As the distribution of biologics becomes more complex, the associated challenges for compliance, quality and security are likely to increase.

Demand for biologics in the United States is expected to exceed $100 billion in 2015. But in meeting this demand, companies are expected to take an increasingly global view. 

India, China and Korea are all being targeted as forums for development by US companies, thanks to their lower costs and, in some cases, easier approval processes. 

In particular, these countries are benefiting from increased interest in biosimilars, a major category for development in the segment in the future, and one which presents a whole manner of challenges when it comes to compliance and quality. 

In the next five-to-ten years, a significant number of biologics will experience patent expiries, and those which take an international approach are most likely to succeed, some industry insiders suggest.

Writing for Express Pharma, Rishiraj Lahiri, Analyst, GBI Research and Dr Vishal Agrawal, Project Manager, GBI Research, explained"Successful companies in the future biosimilars market will be those who can align manufacturing, clinical evaluation, commercialisation and regulatory guidelines in a single strategic framework, and have not only local market dominance, but a significant global presence."

But are the distribution channels currently in place sufficient to support this growth and the increasingly international reach of these products?

Outsourcing is also continuing to increase at both the research and manufacturing stages, placing further pressure on the distribution of both samples and finished products.

End-to-end solutions are likely to be in greater demand to deal with the security threats and logistical challenges presented by the transfer of biologics – and samples – from CROs and CMOs in emerging countries with the markets within the United States and Europe.

Compliance with labelling and documentation guidelines – both valuable in the fight against counterfeit pharmaceuticals – are becoming the increasing focus of regulation, in particular when it comes to the shipment of temperature-controlled pharmaceuticals. 

Cold chains are facing increasing demand as the industry shifts towards a greater focus on biologics, and using one provider minimises the risk of temperature excursions, improving both quality and compliance.

According to TNT Express, which recently launched its PharmaSafe product for cold chain distribution, typically more than 20 parties are involved in an air shipment, bringing with them an increased risk of issues with customs clearance and damaged packaging. 

It claims by using just one provider, using its own aircrafts and delivery networks, accompanied by real-time location monitoring and temperature tracking, these risks are reduced.

It also predicts that over the next five years, demand for air transport for temperature-controlled pharmaceuticals is set to grow 12 percent a year, fuelled by both stricter regulations and growing demand for pharmaceuticals.

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