PHARMACEUTICALS
Kaus – Logistics have been Curia ’ s biggest challenge
As a supplier to pharma and others , Cernick added , Pressure Chemical carries out challenging and dangerous chemistries ; its plant could be viewed as a dangerous neighbour . It has addressed this by investing heavily on recycling and scrubber systems to cut down emissions . Even so , she doubted that the public really understands what the industry does to minimise its impact and deliver safe products ; they still think mostly in terms of exposure to chemicals .
Risk & reward
The regulatory system in the US and the EU , Waltermire observed , has strongly pushed greener manufacturing methods like continuous production and enzymatic reactions but does not reward those who use them . Meanwhile , advances in analytical technology have enabled regulators to push even harder on trace levels of genotoxic impurities and nitroasmines . The result has been product recalls that have further tarnished the industry ’ s image . As a sartan producer , Siegfried was directly confronted with the nitroasmine analytics , Späne said . “ There was no excuse because as soon as we heard that we had to do it , we could thank God that we had a good development analytical department .
They had to work day and night to find a method to get this detected .” The company then talked with its drug substance supplier in Asia , made the different drug products and finally talked with the customer about how to use them . The sartans , she noted , are all generics : customers simply wanted their product delivered to the committed timelines at the risk of penalties . “ The pressure was only from the government to us . There was no dialogue and this was not our mistake because we didn ’ t have it before and we didn ’ t get given an analytical method that would detect it . We had to detect it very quickly ourselves and work together to get the product to the patient . And nobody is paying us the additional cost .” This issue , Boyce agreed , has put extra focus on due diligence in the supply chain . CDMOs now have to check their suppliers ’ ability to show transparency in their processes in general and in particular to carry out a critical assessment of the likelihood of nitrosamine formation , depending on the chemistry . The best way of controlling nitrosamines is to avoid them in the process , she added . Ideally they should be taken out at the start rather than in Phase II-III when a CDMO would typically get involved . “ That ’ s something you would also look at internally to ensure that you understand your supplier ,” she said . “ Also , the chemistry we perform ourselves , we would always now provide certainty , via risk assessments or testing . We put a lot of time and effort into developing the appropriate nitrosamine methods and work closely with our customers to ensure that everything we supply is tested or risk-assessed .”
Who pays ?
Of course , all this comes at a cost . SK Biotek Ireland is constantly balancing the issues of cost versus margin , as with other regulatory burdens . “ Who is the payer at the end of the day is always a concern ,” Boyce concluded . About five years ago , Kaus recalled , Curia began an initiative of looking at every single API process and assessing whether nitrosasmines could be removed from them . Now , after spending a considerable amount of time and money , it is looking at new processes and avoiding any chemical raw material that can lead to them . Developing a nitrosamine-free process – or any greener or more sustainable process - should mean accelerated regulatory approval , Späne suggested . Of course , the system does not work this way . The system is about control , not reward , though Siegfried and others have discussed this with the European Parliament . “ We also have to educate our politicians because they don ’ t really understand what we are talking about ,” she said . “ We really need to get different conditions . If you have a process that is more sustainable , less dirty or uses less material , you should get an advantage . “ We need to think about new processes . This costs money and at present you don ’ t have a regulatory advantage in doing it . We all now have to work together to work with government agencies on how we can motivate accelerated approvals for this kind of chemistry .” •
Boyce – SK Biotek has had to plan ahead more
32 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981