Someone has to do it!

Jacinta George, RSSL, highlights the role of contract laboratories in the drug industry

In the highly competitive world of pharmaceuticals, drug discovery is usually top of the agenda for the pharmaceutical scientists, and time to market is the issue that most often concerns the board of directors.So there is usually little time or space in the laboratory's busy schedule for the seemingly less glamorous routine analyses that are nonetheless necessary for the successful development and commercial exploitation of new pharmaceutical products.

That being the case, the role of the contract laboratory has become increasingly important, and when technical expertise can be matched with an ethos of customer service, the relationship between the contract laboratory and client sponsor can prove highly beneficial for both organisations.

symbiotic relationship

Indeed, whereas the contract laboratory might once have been seen as a useful buffer, able to handle the excess workload of an in-house resource, this relationship has now changed. These days the relationship is more symbiotic. The contract laboratory has become a strategic partner, playing a crucial role in the financial success of the sponsor client.

This is no idle claim. A recent report from the Tufts Centre for the Study of Drug Development, suggests that a manufacturer that can cut drug development times by 19% can save itself up to U$100m. Any outsourcing partner that is able to reduce the time to market has the potential to save the drug company several millions dollars. So when the relationships work well, the contract laboratory is a valuable partner to its clients.

For RSSL Pharma, a contract laboratory for almost 10 years' in the pharmaceutical industry, the secret of success has been in understanding that routine does not imply low-skill. In fact, entirely the opposite is the case.

With a client base spanning the traditional pharmaceutical market and its chemical suppliers, the biotechnology sector, and the herbal medicines market, RSSL Pharma must apply its expertise to a vast array of actives, excipients, solvents, breakdown products and ingredients. Far from being routine, in the sense that this word normally implies, RSSL Pharma's routine work is ever changing and ever challenging.

developing compliance

Method development and validation, including the writing of protocols, for the quantification of residuals, actives and related substances is a big part of the routine work. During the development of actives, many clients will develop an assay for purity, but may not have the resources to develop it sufficiently for regulatory submission.

Other clients entrust the entire method development process to RSSL Pharma.

Now that the drugs used in phase I and phase II clinical trials have to be manufactured to GMP, there is also a greater demand for the analysis of excipients and raw materials at an earlier stage of drug development.

expertise and innovation

Whether methods are developed in house and then transferred, or developed by the contract laboratory, it is, of course, necessary for the contract laboratory to be able to offer expertise and innovation in a wide range of extraction, separation and identification technologies. These include HPLC, GC, ICP, dissolution profiling, NMR and GC-MS instrumentation.

That said, there is clearly little room for innovation when many of the analyses conducted on behalf of clients must be carried out to established Pharmacopoeial standards. On the other hand, in the investigation of product emergencies, an area of particular expertise for RSSL Pharma, under the banner of RSSL's Emergency Response Service (ERS), then the unpredictability and uniqueness of incidents demands innovative thinking, and often the input of expertise from a wide variety of scientific disciplines.

Problems such as physical contamination, off-flavours and taints, precipitation and discolouration can arise due to a variety of factors during the manufacture or storage of pharmaceutical products and their ingredients.

Such incidents may require investigation by microscopists, microbiologists, chemists and even sensory evaluation scientists in order for the problem to be properly explained and resolved.

Extortion threats, deliberate contamination and product counterfeiting investigations are also scenarios that the ERS is called in to assist with.

In many respects, the ERS is a flag-ship service for RSSL Pharma, although the confidential nature of the work makes it difficult for RSSL Pharma to promote the fact.

It is vital that it maintains this confidentiality, especially at the time of the incident. The purpose of every ERS investigation is to provide client companies with information that will help them decide how best to deal with whatever crisis is affecting their products. The last thing any client needs in such a situation is the attention of press and publicity that might force decisions that are unnecessary or otherwise damaging to the company.

Despite the importance of the ERS, the bulk of RSSL Pharma's work is centred on routine analyses geared towards improving the quality and acceptability of products, ironically, avoiding the problems that might require an ERS investigation.

Reformulation of OTC medicines, particularly from the perspective of improving their taste characteristics has also been a growth area for RSSL Pharma, following the acquisition of new product development company LinTech, by RSSL.

future growth

These new services demonstrate a growing willingness from the pharmaceutical industry to outsource even more aspects of drug development, and even drug discovery.

Most independent analysts predict that the demand for contract services will continue to increase. Quoted in US trade magazine, Pharmaceutical Formulation and Quality (May 2004), Ajit Baid, industry manager for pharmaceuticals and biotechnology at Frost & Sullivan says: 'Outsourcing is still in a nascent stage in the pharma industry, with a lot of scope for growth. Contract organisations are increasingly becoming more organised and more tech-savvy. New markets for CROs are emerging in Europe and Asia.

In 2003, the total market for CROs was in excess of U$8.5bn, and I expect this to grow to more that U$14bn by 2007. Around 18-20% of total drug testing will be outsourced.'

firm foothold

For laboratories like RSSL Pharma that already have a firm foothold in the European outsource market, any talk of growth is good news. However, no-one is jumping to conclusions. For laboratories seeking to gain a share of this market, being willing to do the routine jobs that free up time in the in-house laboratories, is just the minimum requirement for entry onto a prospective client's list of preferred suppliers.

As more complex and business critical duties are being outsourced, the demands on contract laboratories are always increasing.

It is a commitment to quality and technical excellence, the ability to innovate, a partnership mentality and an ethos of service, flexibility, a history of investment and reputation, price and added value that are far more important factors in building a business from providing contract laboratory services.