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Contamination risks challenge clinical supply manufacturers

By Emilie Reymond , 23-Oct-2006

Minimising the risk of cross-contamination in the production of medicines for use in clinical trials is a major challenge for manufacturers, who need to implement safety measures in order to avoid production failure.

The manufacture of investigational medicinal products (IMPs) can appear, on the face of it, a fairly straightforward exercise.

 

In reality, it can be a complex logistical challenge, and companies generally need to put in place comprehensive methods and equipment to ensure the safety of production, in terms of contamination.

 

MP5, for example, a French pharmaceutical company specialised in the production of highly potent IMPs, uses different tools to control and minimise the risk of cross-contamination during the manufacturing process.

 

Cross contamination is an important issue for IMP manufacturers mainly because of the nature of the products.

 

"There are few data available on the toxicity of the products we produce because they are in the clinical trial stage," Frederique Turlin, business manager at MP5, told In-PharmaTechnologist.com.

 

"The risk is amplified by the fact that we specialise in highly potent IMPs, which means that a very small quantity has a powerful effect of contamination if measures are not taken."

 

Fundamental to the process for preparing IMPs is the need to comply with the requirements of good manufacturing practice (GMP), which were modified two years ago and now include IMPs.

 

To comply with strict regulations and avoid cross-contamination in production batches, MP5 has adopted several techniques during the production process, such as the use of home made isolators as well as single use equipment.

 

"We use single use equipment to reduce the time spent cleaning," said Turlin.

 

She said there are higher costs involved but it is the price to pay to minimise the risks.

 

Furthermore, the company adapts cleaning methods to each product and this specific cleaning process is conducted after each production containing an active pharmaceutical ingredient (API).

 

Adding to these measures, the firm works on a campaign basis, which means that it conducts only one production at the same time and no production can start before the validation of the previous cleaning.

 

"There is always a high risk of contamination but we can afford to make no mistakes, otherwise we would be wasting entire productions," Turlin concluded.

 

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