Alain Pralong on Sound Risk Management in Biomanufacturing

Alain Pralong, VP New Product Introduction and Technical Life Cycle Management at GlaxoSmithKline Vaccines, speaks to Pharma IQ, about the challenges faced evaluating single-use systems for extractables and leachables and the need for sound risk management in biomanufacturing. Pralong also shares his opinion on the current regulatory landscape.

Pharma IQ: How much of a priority is extractable and leachable testing for you currently? And is it still one of the biggest issues that you have, when implementing single-use systems?

A Pralong: First of all, having a risk assessment on leachables and extractables is a regulatory requirement and, in that sense, it is important. It is a basis, which allows to embed and implement single-use technology successfully and, in the end, also to ensure patient safety in the end. It has a high importance and it needs to be done; no question about that.

Pharma IQ: What is the biggest challenge with regards to extractables and leachables?

A Pralong: It’s the current absence of standards, because, basically, each supplier has, more or less, an own view what are the tests that need to be done. Then, it’s up to the user to define, in this framework of the components that are used, their own. Most are proper leachables and extractables studies and, in that sense, it becomes quite complex and quite costly to go ahead with this. So, I think that standardisation would help a lot and there are quite some drivers in the industry right now to go ahead with creating standards. There are established organisations like DPSA or also the  Bioforum, BPOC, that are now, have, are working on draft of standards or have issued standards already some time ago and the latest is now that the ASTM, the American Society of Testing Material will publish draft standards for balloting, which will then be available for] community to comment.

Pharma IQ: Guidances are available from varying different groups and associations. What’s your opinion on the current regulatory landscape?

A Pralong: For me, one of the issues is, it depends who sits in which of these groups and associations. There is some kind of attendancy, depending where you are and, I think that we need to come above this level of interest, in order to come to a conclusion, which allows industry as a whole, which, industry means, that where, industry means suppliers and users, that they can go ahead and that they can make standards where the suppliers at the end know, into which range of properties they need to develop their single-use groups and users know what their single-use goods can and how they behave under the conditions that have been tested and these conditions need to be worked out in a way, which makes single-use technology feasible, which hangs together with the risk assessment of biotechnology; the manufacturing processes that have been registered in the past, but also, the ones that are currently going through legislation.

Pharma IQ: What’s the biggest difference in implementing single-use systems downstream, rather than upstream and what makes it so much more difficult?

A Pralong: When downstream, you might use raw materials and flash chemicals on the harsher conditions that you have in upstream. In upstream, you work always on the conditions, which support mammalian or patterned cell growth. When you are in the downstream part, you are doing more, in brackets, chemistry, and in that sense, you might work with different temperatures, you might work with different PHs and, in that sense, the stress for a single-use system can be high.

Pharma IQ: What can be done to get past this?

A Pralong: Development, innovation one side and on the other side, it’s also about making sound testing and sound risk management. And when I talk about this, then it’s not just on the synergies side, but it’s also, I suppose, beyond that, it’s about the conditions how chromatographies are done or what resins are in there. So, there is a whole field of innovation that can now work and it’s not only the single-use community that needs to work on; it’s also the other part that can contribute, which are providing the means for the effective purification or the downstream technology.

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