Industry Expert Panel

“We have seen significant outsourcing of early stage R&D from the pharmaceutical industry recently. Are you also observing a similar trend in the areas you work in?”

Paul Wituschek, Vice President of Sales, Development and Clinical Services, Catalent:

As early phase drug development takes the longest time and the majority of resources, and as the pharmaceutical industry continues to seek efficiency gains while accelerating pipeline development, increasing early phase outsourcing and active collaboration with academia has become a common strategy for large Pharma.

Pharma companies are increasingly recognising that through partnering early with a delivery solutions provider, they are more likely to resolve delivery issues and achieve better therapeutic profiles for their drug. This is especially the case for the growing number of insoluble compounds that are also less permeable in the gut. Modified release technologies can be formulated at an early stage to better target a particular site of delivery, or to slow the degradation of the active pharmaceutical and control plasma levels, reducing unwanted side-effects.

“How has the containment industry changed over the past five years and what are the impacts of this?”

Harald Stahl, Senior Pharmaceutical Technologist, GEA Pharma Systems:

The pharmaceutical industry’s keen interest in containment started over 10 years ago and has grown rapidly ever since. The reasons for the increased interest came from two main sources: an increasing number of potent compounds coming out of the R&D pipelines and an increasing focus on Health and Safety.

The early adopters of containment technology were, naturally, the R&D-oriented Pharma companies in the western countries. Guidelines like EU Directive 89/391 EEC laid down fundamental requirements relating to containment such as the responsibility of employers for the health of their workforce, the need to minimise risk and the principle that collective protection should always be given priority over individual measures.

These guidelines forced pharmaceutical companies to consider ways in which they could contain whole working areas in preference to providing employees with individual containment suits. They also encouraged the industry to form expert panels to establish how it would be possible to harmonise the way in which the toxicity of an API could be accurately determined and how the performance of a containment system should be assessed.

As more drugs came off patent, so came the need for the generics industry to focus on containment. Many of these companies were operating in emerging countries where health and safety rules were less strict and where the use of air suits was both common and generally accepted. However, it didn’t take long before these companies realised that modern containment equipment, without the need for air suits, would provide them with better housekeeping; the ability to change much faster from product A to B as in most cases, no extensive room cleaning is required; a significantly reduced risk of cross contamination and a much better working environment for their staff. For these reasons, it made good commercial sense and was quickly taken up by the generic companies worldwide.

Since then, and despite the impressive performance of containment systems, the current trend is to accept the fact that there are no fully closed systems and so companies are increasingly taking a risk-based approach to evaluate the safe dose to which operators can be exposed. The European Medicines Agency (EMA) has acknowledged this in its latest advice on the setting of limits based on a risk analysis.