The vital role APC plays in support of the US National Biotechnology & Biomanufacturing Initiative

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The COVID-19 pandemic, Brexit and the war in Ukraine have brought into sharp focus the precarious nature of global supply chains and the threats which exist to the ability of individual nations to access vital materials which impact on the health and economic well-being of their citizens.  This is particularly keenly felt in the Biotech/Pharma industry.    

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The recent signing of an Executive Order by President Biden, to launch a National Biotechnology and Biomanufacturing Initiative is perhaps the most significant move yet by the US government in response to this. Last week, the White House hosted a Summit on the National Biotechnology and Biomanufacturing Initiative during which it was planned that the cabinet agencies would announce a wide range of new investments and resources that will enable the US to harness the full potential of biotechnology and biomanufacturing and advance the President’s Executive Order. 

Specifically one of the key planks to the Initiative is to “Grow Domestic Biomanufacturing Capacity”. In recent decades, US pharma and biotech companies have in large numbers outsourced their manufacturing to countries like India and China, because of lack of sufficient domestic manufacturing capacity. Thus, the Initiative is designed to build, revitalize, and secure national infrastructure for biomanufacturing across America. In doing so, there is an opportunity for these companies to create jobs at home whilst at the same time having more robust supply chains and greater control and oversight of tech transfer as their drugs progress through the various stages of development. 

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However, the building of more domestic manufacturing infrastructure is not a “silver bullet” solution. Each medicine has its own unique process development challenges and if not properly understood and addressed can often cause costly batch failures and expensive delays in getting material to clinic.   

Drug development companies without their own in-house manufacturing capability who outsource this activity to Contract Development & Manufacturing Organizations (CDMO’s) are acutely aware of this. The typical CDMO business model is to focus more on the Manufacturing than on the Development. This is because they have a depreciating asset in the background (i.e. their plant) which they need to fill. So they’ll often treat the development as a loss leader in order to secure a longer term manufacturing contract. Generally speaking, these CDMO’s are not set up, either equipment-wise or from a business model perspective, to get an in-depth understanding of the process to make a medicine due to the commercial pressure to “keep the tanks filled”. But this lack of understanding means that the process is nowhere near good enough to produce large volumes of material in an efficient or cost-effective manner. Yet the drug development company may often have tied themselves into a relationship with a CDMO who is incapable of reliable or efficient production of the medicine because of this lack of process understanding.

Thus it is clear that if the US government Initiative is to fully bear fruit, the issue of process development cannot be ignored.
This is where APC & VLE come in!

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For more than a decade, driven by our “Process Advancing Medicine” philosophy, we have been working with 8 of the top 10 Big Pharma and a range of other drug development companies across the world – utilizing our expertise and infrastructure in an "information partnership" approach with them. Our singular focus on process understanding, means that unlike the CDMO’s, we can effectively, and in an un-biased manner, de-couple development from manufacturing for these companies (very many of whom are in the US). This provides their process dev, tech transfer and manufacturing groups with ownership of in-depth knowledge/information related to their medicines and empowers them with full control of their CMC strategy – giving them increased portability and flexibility of (i) where and (ii) how their products can be manufactured. At the same time, this approach arms them with the in-depth information required to meet the ever-increasing demands from the regulatory authorities.

Our only interest is in developing for our clients a process which works and is fully understood. If our clients are armed with a deep understanding of the Critical Process Parameters (CPPs) of their process, they can make an informed decision about what the most appropriate manufacturing infrastructure is to make their medicine – whether that means re-patriating the manufacture of an existing product back to a US location, or designing the process for new products in such a way as they can be deployed made locally in an economic and efficient way for the benefit of all.