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Encouraging
'enviropreneurship'
Applying green chemistry principles earlier in the
drug development process could dramatically
reduce the environmental impact of pharmaceuticals
manufacture, Nitesh Mehta reports
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competition increases. This leads to a commercialise a green chemistry and
drastic reduction in its price, shrinking green engineering based process for the
pharma company margins. Green entire manufacturing process of a pharma
chemistry processes improve economic intermediate or drug. The objective was
competitiveness, and hence the to make the entire synthetic chemistry
possibility of sustaining profitability. based process ‘greener’. Currently, we
Around four years ago, one of the are in the final stage of negotiations with
fastest growing pharma companies in one of the largest pharma companies in
India approached Newreka to work on India for one of its molecules for which
one of its molecules. This antiretroviral it intends to scale-up manufacturing
drug prevents the transfer of virus from capacity to 100t/year. The company
a HIV infected mother to the child in the is conscious about the environmental
womb, thereby helping to reduce the footprint of its manufacturing operations
number of HIV positive babies being and hence intends to reduce its E-Factor
born. before expanding production capacities
The firm wanted us to develop a green for the molecule.
chemistry based process for the first four Every pharma company could benefit
steps of this molecule, all of which were from green chemistry approaches. Existing
very polluting and also hazardous. The synthetic chemistry processes offer
first step was a diazotisation-hydrolysis huge scope to improve economic and
generating huge quantities of high environmental competitiveness. The gap
acidic effluents. The second was a between theoretical yield and the yield
nitration, generating huge quantities achieved by using synthetic chemistry
of highly acidic effluent containing processes is huge. The raw material
sulphuric – nitric mixture. The third was consumptions are much higher than
a chlorination, again generating chlorine theoretical requirements and the potential
containing acidic effluent, red in colour. of catalysis is largely unexplored.
The fourth step was a high pressure Globally, however, the challenge
and exothermic hydrogenation using of effluent pollution is far bigger than
pyrophoric catalyst like Raney Ni and any one company or group can tackle
methanol as a solvent. Safety was the alone. What is needed is an approach
biggest concern for this step. that is non-linear and has the potential
Our customer’s synthetic chemistry to give exponential results. At Newreka,
process for these four steps together had we would like to expand our model of
an E-Factor of 175: it produced 175lb of Green chemistry: promises to clean up pharmaceutical sector ‘enviropreneurship’ beyond the confines
waste/lb of intermediate manufactured. of our own laboratory space and create
As the volumes of these intermediates an environment where entrepreneurs
started touching 120t/year, managing such huge globally take on an environmental challenge,
quantities of highly acidic waste (175 x 120 = ca create a solution for that problem, offer that
20,000t/year) started to become a challenge. Also,
there was ongoing pressure to supply antiretroviral
'During the solution to society or industry and in the process
generate business and profits.
development phase
drugs at lower prices, hence the firm’s margins were
shrinking.
What we are proposing is encouraging chemists
and chemical engineers around the world – including
So, the reasons this pharma company of a new molecule, young students just out of college – to take on being
approached us were: ‘enviropreneurs’. If we can create such an ecosystem
• To reduce the reduce E-Factor; pharma companies then it may become possible to work on and
• To improve economic competitiveness; and
• To develop an inherently safer process. are in a rush to develop solutions simultaneously for thousands of
environmental challenges at a time. Creating such an
commercialise…
Inside of an exclusive partnership, over a couple
of years, we developed green chemistry processes
ecosystem will require seed capital from governments
and/or private investors, establishing an IP system to
for all the four steps to reduce the E-Factor from
175 to 17 – a 90% reduction. In addition, the
Hence, most of the protect their ideas, technical assistance and other
resources to transform the enviropreneur’s idea into
customer’s yield for that intermediate improved by time, the processes a commercially viable solution.
250%. We didn’t change the route of synthesis; At a time when clean water is emerging as key
we developed an alternative process by working filed with regulators challenge for sustainability of human activity on
on the following three aspects:
• Exploring new catalysts and reducing agents during launch are the planet, effluents from the pharma API industry
are a matter of serious concern. The problem can
that are inherently safe and more selective;
• Optimising the process by working on raw material
synthetic chemistry either be treated as threat or it can be turned into
opportunities for chemists and chemical engineers
consumptions, process parameters, etc; and
• Recycling at source by reintroducing the reaction
based processed to find new solutions based on the principles of
green chemistry and green engineering.
or extraction medium, generated after isolation of where the E-Factor is
the intermediates at various stages, back to the Nitesh H. Mehta is founder and director of Newreka
same process. very high' Green-Synth Technologies, based in Goregaon
This was the first time that we partnered with (East), Mumbai, India.