With the burgeoning interest in the use of disposables for the production of modern biopharmaceutical products, the level of scrutiny surrounding the topic of Leachables and Extractables has moved into a higher gear. It seems that there is an endless amount of attention being paid to this topic because of the potential impact on patients receiving biopharmaceutical based therapies.

As a result, there is a frantic level of regulatory activity as scientists attempt to predict and quantify whether there’s any regulatory impact, particularly as it relates to safety.

Although issues connected with Leachables and Extractables has been discussed for over 25 years, the recent trend towards the use of new disposable methods of production which includes; wave bags, disposable plastic bioreactor inserts and their myriad of associated tubing and samplers, means that the probability of some elastomer eluting from the components or alternatively some breakdown product washing off the material might be much greater.

With the potential for both Leachables and Extractables to have a marked effect on the quality and safety of protein therapeutics, the challenge is therefore on to find better testing methods to provide an adequate level of sensitivity and specificity that will assure both quality and safety concerns are met.

Similarly, provider companies are looking at newer materials that may not have the same potential contaminating profile which might reduce or minimize the problem.

With all this activity going on its often helpful to solicit the help of a consultant that is aware of the issue s to help guide a path forward.

In developing protein therapeutics that may be sensitive to contact with rubber and plastic components, the potential effect of Leachables over time can become a critical processing consideration. To help to address this issue, part of the modern approach is to use Risk Assessment and Risk Mitigation strategies to first quantify the extent of the potential risk and then to subsequently ameliorate possible negative outcomes that are identified. This is a really important step and should be planned carefully as it can save a lot of effort if it’s completed according to a well-defined approach.

With the projected level of activity in using disposable production systems expected to increase markedly over the next 5-10 years, we can expect to see this area receive even more attention. Currently, various industry associations are interfacing with the FDA to develop various standards to help to address these issues in order to prevent them from becoming a limiting condition to the application of this technology.