HPAPIs And Bioconjugates - Pharmaceutical Technology

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HPAPIs And Bioconjugates
Tom Gelineau, Director, Business Development, at SAFC, speaks to Pharmaceutical Technology Europe about the market for HPAPIs and the key trends influencing HPAPI bioconjugates.

Pharmaceutical Technology Europe
Volume 23, Issue 9

What challenges lead some pharma manufacturers and contract manufacturers to shy away from HPAPIs or bioconjugates? How is the industry overcoming these issues?

It is extremely important to create a safe environment to manufacture them in and this requires a lot of investment to build and maintain. With that said, it is not just the initial capital investment, but the continuing costs to operate in a safe and compliant manner. The pharmaceutical companies that are looking to develop these drugs put the emphasis on the CMO to be responsible for ensuring that the proper infrastructure is in place to operate things correctly. As such, there have been companies that have looked at the HPAPI market as an easy one to get into, until they recognized all that would be involved in order to operate safely.

As the industry further realizes the importance of protecting their workers and the environment as well as the product, a number of CMOs are now making sure they put the proper controls in place to become Safebridge certified. SAFC has already established this and it is a major differentiator of our business.

Do you think the growth opportunities in HPAPIs and bioconjugates justify the expensive investment required in specialised containment and manufacturing technologies?

Yes, we do. We have recently made quite a number of investments, so as an organization we absolutely do believe that the opportunities justify the expenditure. We are already working with a number of technology innovators in that space which is an important part of justifying the long term commitment and investment. We have also seen that our smaller scale capacity is already filling up nicely which furthers this justification.

Looking ahead five years from now, how do you see the market for HPAPIs and bioconjugates evolving?

I see nothing but upsides. The bioconjugate area, in particular, is in the early stages of technology development, so it is going to be critical that over the next few years we start to see some successes in that area. Seattle Genetics has submitted a biologic license agreement for brentuximab vedotin, and this could be one of the first potent drug–antibody conjugates on the market.

I believe the next few years will be very telling; there is a high degree of confidence that these conjugates are going to be successful. I think that almost every major pharmaceutical company has taken a licence to, and invested in, this type of technology. That is a pretty strong endorsement that the major pharmaceutical companies believe ADCs are going to be an important technology over the next few years.


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