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Piramal Pharma Solutions – Who are we?

Piramal Pharma Solutions may not be known to everyone in the Scottish Life Science Community but we form part of a long history of chemical and biopharmaceutical manufacturing in Grangemouth.

Who are we?

We are a site of approximately 170 staff who form part of a global conglomerate with interests in pharmaceuticals, biopharmaceuticals, API manufacturing, discovery services, critical care products, realty and glass manufacture.

The history of manufacturing on our site started in 1919 with Scottish Dyes, the site eventually becoming part of ICI, until business units were divested with our facility becoming part of Zeneca until further divestment to Avecia Biologics.  Avecia Biologics then sold our unit to Piramal in 2005.

What do we do?

This is the interesting bit ! Since 2004 we have been working on the development and manufacture of Antibody Drug Conjugates and a wide variety of other bio-conjugates.  If you don’t know what Antibody Drug Conjugates (ADCs) are, they are biopharmaceutical products, typically a monoclonal antibody to which a cytotoxic drug (payload) is attached.  Increasingly, antibodies conjugated to a cytotoxic drug are being use in the treatment of many forms of cancer as they allow targeting of specific antigens which are proteins expressed on the surface of cells.  In cancer cells, specific antigens are often overexpressed which make them easier to target increasing the selectivity of the cytotoxic payload.   Traditional chemotherapeutic agents kill healthy and diseased cells indiscriminately, so by attaching these small molecules to an antibody we are able to make them more selective to cancer cells that overexpress specific antigens.  Note the use of the word “more”…

How have we grown?

In 2004 the Grangemouth team embarked on the development and manufacture of our first ADC which has went on to become the commercial product known globally as Adcetris®.  From 2011 until 2013 was the only ADC on the market with Mylotarg having been voluntarily withdrawn by Pfizer.  2013 saw the introduction of the Genentech product Kadcyla which is an ADC built on the oncology drug Herceptin.

From 2005 the site grew with an increased demand for our contract manufacturing services and by 2012 we had supported development and manufacturing of a large percentage of the ADC products in clinical trials.

To meet the growing demand for our specialist service the site has had to grow significantly and as such has seen a doubling in headcount over the past 5 years.  This growth can be mainly attributed to the increase in demand from the SME biotech sector as well as continued collaboration with large pharma entering into the area of bio-conjugation.  This change meant an increased focus in both process and analytical development where we have grown significantly and excel.  Together with a change in customer base, we have also seen more projects going further in the clinic which drives changes in manufacturing scale (and complexity) needed to support clinical demand.

What our challenges?

Continued growth brings challenges of its own.  The continuing need for hire and retain good people is always key and in parallel, our internal systems have had to be adapted to cope with the increased headcount.  Facilities and equipment have also grown and compliance has remained key.  Together with these obvious challenges, we have also had to manage the changing landscape of the industry.  Whilst several ADC products have had great success or show promise, the high toxicity of the small molecule component remains a challenge through off target toxicity.  This has been the major reason for many products failing in the clinic as the “therapeutic window” cannot be made wide enough to achieve the desired therapeutic effect without the unwanted side effects.

This has certainly driven a lot of research within the industry and we have started to see more “non-ADC” bioconjugates coming through our facility and in areas other than oncology.  Again these bring challenges as conjugation chemistries and modes of action may be novel requiring us to be more development focussed, often employing new engineering strategies within manufacturing.

Where are we going?

We have continued to expand both on site at Grangemouth and within other Piramal facilities that enhance our service offerings.  Our facility in Aurora (Canada) supplies non or low cytotoxicity drug linker, our Riverview (US) able to supply higher potency (HPAPI) drugs.  Together with our fill-finish site in Lexington (US) we have the ability to support most elements of the ADC supply chain as an integrated service.

On site we have expanded the number of commercial suites available here at Grangemouth and are now actively looking at further expansion opportunities to support products going into late stage development and potentially commercial supply.

ADC / Bioconjugation manufacturing will continue apace here at Grangemouth and through our talented teams we will continue to support our customers and take more products through the clinic benefitting patients across the globe.

 

Blog contribution by Allan Davidson, Head of Development, Piramal Pharma Solutions Grangemouth

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