Boosting Bioavailability Through Partnerships



Pharma IQ
09/02/2010

If the trends that have been seen in the pharmaceutical industry over the past few years prove anything, it is that drug development companies are increasingly recognising the value of teamwork. There is plenty of evidence that businesses in the sector are seeing the benefits that partnerships with contract research organisations can offer, at a range of points in the production process.

One stage where working with a partner is now becoming more common is testing in relation to both bioavailability and bioequivalence. Both of the concepts are based around the effectiveness of drugs and their ability to reach the required site of action, which means they play a key role in the calculation of dosage.

Mark Hammond, chief executive officer for Melbourn Scientific, recently outlined the benefits that a partnership can offer to pharmaceutical organisations that are aiming to get new products to market but find themselves at such a stage.

"An experienced partner will ensure that the formulation and testing procedures reflect the adequate requirements for a pre-clinical or first-in-man trial, whilst making certain that sufficient data is collated for regulatory purposes at each stage," he explained.

"This will help the product get to clinic in a cost-effective and time-efficient manner."

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Mr Hammond made the comment as his organisation announced the launch of its new fast formulation screening service, which is designed to speed up the development of drug formulations which face problems in terms of poor bioavailability.

A key aspect of the service, which also follows Good Manufacturing Practice for early trials, is the introduction of platform technology designed to ensure researchers can test a range of formulations. Melbourn Scientific has emphasised that the approach would allow clients to work closely with it on the issue of bioavailability.

Discussing the issue, Mr Hammond said: "Our clients are at the forefront of innovation and some also want to have a hands-on approach. 

"We offer them the opportunity to work alongside our scientists at our facilities in dedicated project rooms that protects their confidentiality and that of our other clients."

The introduction of Melbourn Scientific's new service has come just months after the UK-based organisation celebrated the 20th anniversary of its launch. With a team of around 60 analysts, the organisation has knowledge in a range of testing areas as well as formulation.

It hinted at its expertise in the area of dosage last year, when it announced the introduction of a new analytical service in which it makes use of Terahertz Pulsed Imaging to create 3D pictures of solid dosage systems. Such data can then be used to assess and confirm the attributes of drugs, including thickness and coating uniformity.

Speaking in October, Mr Hammond highlighted the potential benefits of the technology, saying: "This provides new insights and will enable us to quickly correlate the release of the active ingredient with the density or thickness of the coating. This increased understanding then allows trouble free scale up and product optimisation."

While bioavailability and general issues related to it are important, the comments from Mr Hammond highlight how speed is of the essence for many drug development firms as they look to make decisions on the topics and get their creations onto the market as quickly as possible.

The speed with which organisations react may differ but, no matter how quickly the subject is approached, bioavailability remains a vital part of the regulatory approval process which those creating innovative new treatments must go through. As the work and experiences of Melbourn Scientific suggest, partnerships have become a key aspect as organisations look to meet such needs, while they will arguably only become more prominent in the coming years.