India’s pharma API industry discusses green chemistry concepts

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A two-day conference by Green ChemisTree Foundation points to industry’s gradual growing response towards GC&E practices and the overall advancements in its implementation

A two-day conference and EXPO on ‘Advancing Implementation of Green Chemistry and Engineering in the Indian Pharma Industry’ was recently organised by Green ChemisTree Foundation in collaboration with the ACS-Green Chemistry Institute’s Pharmaceutical Roundtable (GCIPR) in Hyderabad.

The main objectives of the conference were to provide subject-specific interactions on topics pertinent for green chemistry and engineering (GC&E) integration in the pharma API industry and to facilitate learning of green chemistry implementation strategies and practices from successful case studies.

The conference was attended by over 200 senior representatives from industry, solution providers, government bodies, regulatory agencies, industry associations and media. Scientists from Hetero Research Foundation, GVK Biosciences, Laurus Labs and Natco Pharma attended the one-on-one meetings.

The conference was organised in collaboration with ACS-Green Chemistry Institute’s Pharmaceutical Roundtable (GCIPR); and supported by Telangana State Pollution Control Board (TSPCB). Companies including Bristol Myers Squibb India, Laurus Labs, Hikal, Natco Pharma, GVK Biosciences and Pfizer India Healthcare served as industry partners. The Bulk Drug Manufacturers Association of India (BDMA), PHARMEXCIL, and Pharmaceutical Supply Chain Initiative (PSCI) supported the Conference as Associate Partners, whereas the Research and Innovation Circle of Hyderabad (RICH) was on-board for the first time to serve as the Knowledge Partner to the conference. Continuing the strong support and active involvement of past years, Express Pharma continued was one of the conference media partners this year as well.

While a Pharma Leadership Summit and workshop on bio-catalysis was held on the first day, the second day had the GCIPR workshop on Essential Tools & Techniques and a seminar on Ready-to-Implement Tools, Technologies & Solutions. The structure and content of the conference provided a conducive platform for solution provider companies to engage in focussed interactions with the industry participants across the two days.

The conference was inaugurated and attended by senior representatives from pharma industry, industry associations, government and regulatory bodies including Telangana and Andhra State Pollution Control Boards. Their presence indicated their endorsement of GC&E practices while their messages to the audience emphasised the role of each stakeholder towards accelerating GC&E implementation in Indian pharma API industry. Gracing the inaugural dais were Dr Juan Colberg, Senior Director, Pfizer, US; Dr David Constable, Science Director, American Chemical Society – Green Chemistry Institute; RK Agarwal, Managing Director, Nakoda Chemicals; Prof S Dayanand, Dept of Animal Sciences, School of Life Sciences, University of Hyderabad; Dr Guy Humphrey, Distinguished Senior Investigator, MSD, US; and Nitesh Mehta, Conference Convener and Co-Founder – Green ChemisTree Foundation and founding director of Newreka Green Synth Technologies.

Pharma Leadership Summit

The objective of the Pharma Leadership Summit was primarily to bring together leaders from the Indian pharma industry to collectively engaging in various aspects of GC&E implementation – from identifying opportunities, to recognising gaps, getting acquainted to collaborative models and enabling platforms, to exploring emerging tools and solutions for advancing the implementation of GC&E practices in the industry.

The session commenced with two keynote addresses by Dr David Constable, Science Director, ACS– Green Chemistry Institute, who shared a global perspective on GC&E implementation and sustainability in the pharma industry; followed by Sai Sethuram, Head, Product & Portfolio Development, Pfizer Healthcare, who spoke on the importance of sustainability in the Indian pharma industry for emerging as a robust and sustainable supplier to the global pharma industry.

The talk by Dr Guy Humphrey, Distinguished Senior Investigator, MSD (Merck) US, shared insights on the business-case for green chemistry and how over the years, Merck has been strategically and systematically investing in the field of green chemistry for their products. This outlook was reinforced by Dr Rajappa Vaidyanathan, Group Director and Head, Chemical Development and API Supply, Bristol Myers Squibb, in his talk, wherein he elaborated on various case-studies citing examples on how BMS has been integrating the application of green chemistry principles in early phase development processes.

Dr Sudhir Nambiar, President – R&T, Hikal spoke on his company’s journey towards GC&E implementation, and outlined the events leading from identification to implementation of GC&E practices at Hikal. This was pertinent as Hikal is the first Indian pharma company which is now on-board with the ACS-Green Chemistry Pharmaceutical Roundtable (GCIPR) as a Member Company.

This session was followed by Dr Vilas Dahanukar, R&D Director, Bioxera Research India who pointed out various gaps and opportunities of implementing GC&E practices in the pharma sector, further emphasising the need to develop a mind-set for greener and simpler processes, and newer approaches to problem solving.

Speaking in the last session of the summit, Dr Juan Colberg, Senior Director, Pfizer, US spoke about green chemistry and manufacturing technologies at Pfizer. He remarked that the challenges in resource and environmental sustainability requires more efficient and benign technologies for chemical processes and emphasised that the importance of manufacturing products through green chemistry means that these can potentially addresses such challenges.

Workshop on bio-catalysis in pharma API industry

The objective of this workshop was to have focussed deliberation on exploring the real-time potential of bio-catalysis in pharma API synthesis. The content of the workshop was designed to expand the technical understanding of bio-catalysis, while also learn from successful case-studies and explore relevant bio-catalytic solutions vis-à-vis the pharma API industry’s challenges and requirements.

The session commenced with a keynote address and half-day technical workshop by subject expert, Prof Nicholas Turner, Professor of Chemical Biology, School of Chemistry, Manchester Institute of Biotechnology, UK. In his session, he provided an introduction to biocatalysis in the pharma industry, illustrated with examples the various biocatalytic pathways that can make manufacturing of pharma APIs greener, and posited a need to increase application of biocatalysis in discovery chemistry.

The next session was conducted by Dr Guy Humphrey, Distinguished Senior Investigator, MSD (Merck), US, who discussed the role of biocatalysis in green and sustainable development. He opined that enzymes specificity, selectivity, ability to be evolved are key propertiesthat create aspirational opportunities and the answer to the chemist’s question “do you have an enzyme that can do x, y or z?” is no longer ‘Yes’ or ‘No’. It’s increasingly ‘Yes’ or ‘Not yet’. The biocatalysis case-studies as presented by Dr Humphrey were reportedly shared for the very first time in a public forum and the workshop participants were fortunate to be able to learn from these very exciting projects being done at Merck, US. Similarly Dr Juan Colberg shared relevant case-studies from Pfizer to illustrate the advantages of bio-catalysis in pharma synthesis while Dr Ishwar B Bajaj, Senior Scientific Manager, Biocon shared case-studies on the application of biocatalysis in syntheses of complex APIs.

In the last session of the workshop, presenters shared pharma API relevant technologies and solutions in the bio-catalysis space. Suresh Kumar from Advanced Enzymes Technologies, discussed the viability of enzymes as “Green Catalysts in the Pharma Industry,” and presented case-studies where AET enzymes have shown break-through results in complex API synthesis. The last presenter, Saravanan Jothi, Iosynth Labs, deliberated on white biotechnology and its application in chiral synthesis. He stated that bio-catalysis is an effective tool for achieving chiral purity, which is critical in the pharma industry.

Besides the presentations, participants at the workshop also continued with offline interactions and focussed discussions in the break hours with experts like Prof Nick Turner present throught the conference.

GCIPR workshop on essential tools and techniques

The workshop was designed to facilitate learning from the collective efforts of GCIPR towards performing several PMI benchmarking exercises of chemical processes across  different development stages over the last one decade within the member companies of the Green Chemistry Institute’s Pharmaceutical Roundtable (GCIPR). The workshop highlighted on how smarter decisions on solvents (including water) and raw materials using the solvent and reagent selection guides can result quickly in significant reductions of wastes, and enhance greener and more sustainable processing.

The first session was conducted by Dr Guy Humphrey, who introduced the objectives and background of the GCIPR model, and set the context for sustainability in the pharma industry. He stated that GC&E enables lowest cost API production, helps mitigate supply-chain risks and presented examples on how GCIPR catalyses innovative approaches to improving process efficiency in the sector.

This was followed by a session by Dr David Constables on PMI metrics, with extensive examples and hands-on exercises. After a detailed introduction on the solvent and reagent selection guides, he demonstrated how R&D teams could integrate these tools on a day-to-day basis.

Industrial experts like Dr Bhuvaneshwari Sridhar, Head of API & R&D, Pfizer Healthcare India, Dr Rajappa Vaidyanathan, Group Director & Head, Chem Dev & API Supply, Bristol-Myers Squibb, India and Dr Guy Humphrey, Distinguished Senior Investigator, MSD (Merck), US shared relevant and real-time examples of integrating GCIPR tools and techniques in making conventional synthesis ‘greener’.

Mehta, Conference Convener and Co-founder, Green ChemisTree Foundation, concluded the session by acknowledging the GCIPR for their generous support and partnership in forwarding the “Green Chemistry Initiative for Pharma Industry” in India over the years. He also reiterated the importance and relevance of the GCIPR tools and techniques for the pharma industry in India.

Tools, technologies and solutions in GC&E

The seminar on ‘Ready-to-Implement’ Technologies and Solutions, was designed to bring together GC&E solutions at the door-step of participating companies. Combined with case-study presentations and demonstrations, the presentations in the seminar introduced emerging tools, technologies and environmental solutions which have the potential to address industry’s immediate environmental and process-related challenges. The seminar was categorised into two distinct categories, with the first half being dedicated to tools and technologies applicable at the R&D stage and the second session about those available for process, manufacturing and operations stage.

The first session was commenced with a keynote address by Dr Rakeshwar Bandichhor, Director and CoE Chemistry Head – API R&D, Dr Reddy’s Laboratories who provided a consolidated insight into the array of GC&E tools and techniques which R&D teams can incorporate at various process-development stages. The next presenter, Dr Satya Lakshmi Oruganty, Director – LifeSciences – Enterprise Analytics and Intelligence, PerkinElmer, further discussed the various lab informatics tools as developed and offered by PerkinElmer.

The talk by Dr Sivakumar, Technical Services Manager, Johnson Matthey, discussed the use and applications of homogenous hydrogen and through case studies and examples highlighted how optimised homogeneous catalytic system can offer safer, milder conditions (lower temperature and/or pressure), increased chemoselectivity and functional group tolerance (e.g. to halogens). He also explained how these catalysts help in creating simpler work-up procedures and most importantly help in reducing waste generation (as compared to hydrides).

The next presenter, Virendra Chouhan, GM, Equinox Software & Services discussed an innovative Multi Batch Distillation System (MBDS) software technology for carrying out distillation using a stand-alone advanced and effective tool. The MBDS is a user friendly tool developed by Equinox in association with Stochastic LLC (US). He shared examples highlighted the functioning of this tool, and how it can handle both batch and continuous distillations.

Prathamesh Kulkarni, from ACS International India discussed the CAS’ SciFinder Tool, which  is a research discovery application that provides integrated access to the world’s most comprehensive and authoritative source of references, substances and reactions. With the help of case studies, he explained the functioning of CAS SciFinder Tool to find green synthetic routes for API molecules, various green reactions and ‘green’ solvent reactions; and various other parameters as required.

Dr Shailaja Donempudi, Senior Principal Scientist, CSIR-Indian Institute of Chemical Technology (CSIR-IICT) in her talk briefly shared the journey of 75 years and the focus areas as evolved over the years at IICT. She also shared various case-studies and examples where-in the institute demonstrated development of sustainable and robust ‘green’ solutions in the areas of multistep and asymmetric synthesis, flow chemistry, parallel synthesis, biotransformations, bench scale level to pilot plant facility, technology for organo-fluoro chemistry, reactors for gas and liquid phase reactions, photochemical reactions, and supercritical carbon dioxide extraction.

The second session on GC&E solutions and technologies for process manufacturing and operations level, included four presentations, starting with Pratas Baruah, National Sales Head – ACC Geocycle who spoke on the efficacy of ‘co-processing’ as a sustainable and compliant waste management solution for the pharma API industry. Dr Prashant Waske, Mettler Toledo, presented Mettler Toledo’s expertise in offering process safety and process optimisation engineering solutions while Ankur Turakhia discussed a ‘green’ approach to ZLD, Sugam Pariyavaran Vikalp’s innovation ZLD solution of “Constructed Geological Filter System”.

The last presentation in the seminar was by Megha Shanbhag, Business Development Manager, Newreka Green Synth Technologies who discussed their RecycleSource solutions for API and the pharma industry. He elaborated on the current reality of this industry generating multiple effluent streams with widely differing quantities and characteristics. Taking into account this reality, Newreka’s platform technologies are developed for recycling effluent streams in early stage pharma synthesis, particularly for those API molecules which are high in volume and thus high in effluent. With relevant examples and successful case-studies, she shared Neweka’s platform technologies and the customer-friendly business model.

The conference was followed by one-day workshop for teachers and students on “Essential Tools and Guides for Green Chemistry Education and Research,” held at K J Somaiya College of Science and Commerce, Mumbai.