Narendra Ambhaikar
Senior Director, Teva Pharmaceuticals
LINKS
Experience
Head - Technical Services, TAPI India
Teva Pharmaceuticals
New and existing Generic APIs: new products & their process evaluations, technology transfers and commercial production
Director, Head - R&D (APIs and Intermediates)
Piramal Enterprises
Led synthetic and analytical teams in the CRAMS business of Piramal. Enabled teams to generate innovative ideas for the business and deliver molecules (ranging from kilos to metric ton scale) via cost effective and green processes.
NARENDRA AMBHAIKAR, DHILEEP KRISHNAMURTHY
Piramal Enterprises Limited
Piramal Enterprises Limited
Group Leader, Process Research & Development
Dr. Reddy's Laboratories
Route scouting and process development of NCEs, Intermediates and Generic APIs
Scientist I, then Scientist II - Chemical Development
Vertex Pharmaceuticals (San Diego)
Process chemistry (R&D) of clinical candidates and intermediates for HCV and Cystic Fibrosis. Key Publication: Organic Process Research and Development 2015, 19(1), 270–283.
Post-Doctoral Scholar (with Prof. Phil Baran)
The Scripps Research Institute (La Jolla)
Total Synthesis of Complex Natural Products: Indole Alkaloids Stephacidins and Avrainvillamide involving New Synthetic Transformations. Key Publications: 1) Journal of the American Chemical Society 2006, 128(26), 8678-8693. 2) Angewandte Chemie International Edition 2005, 44(4), 606-609.
Summer Trainee
Sanofi (formerly Hoechst)
Pilot plant and production, including formulation manufacturing
Education
Emory University (U.S.A.)
Ph.D., Organic Chemistry (Adviser: Prof. Dennis Liotta)
Doctoral Work in Mechanism Driven New Reactions Employing Oxazolidinone and Thiazolidethione Chiral Auxiliaries. Key Publication: Journal of the American Chemical Society, 2003, 125 (13), 3690–3691.
U.D.C.T., Mumbai, India
M.Sc.Tech., Pharmaceutical Chemistry
Investigated applications of chemistry and chemical engineering in the manufacturing of Pharmaceuticals and Fine Chemicals
Process research as a tool to attain Green Chemistry in the Pharmaceutical Industry
NARENDRA AMBHAIKAR, DHILEEP KRISHNAMURTHY
Piramal Enterprises Limited, Ennore Express Highway, Ennore, Chennai, Tamilnadu 600057, India
Piramal Enterprises Limited, Ennore Express Highway, Ennore, Chennai, Tamilnadu 600057, India
KEYWORDS: R&D, API, Green Chemistry by Design (GCbD), Process Research, synthesis, manufacture
ABSTRACT: The pharmaceutical manufacturing industry faces the challenging task of operating sustainably with minimal safety, cost and environmental impact. While the ‘D’ part or process development in R&D is a very critical activity toward the scale-up of Active Pharmaceutical Ingredients (APIs) and intermediates, the ‘R’ part (process research) can also profoundly influence the API manufacturing industry; and it can be a deciding factor in the greenness of the process. The concept of Green Chemistry by Design (GCbD) enables one to understand the relationship between process research, sustainability and economics with respect to API. Proactively designing synthetic routes by recognizing criteria such as safety, environmental, legal, economics, control as well as throughput is an important step in the selection of a practical synthetic route. More often than not, a cost effective process is a green process. Existing and emerging scientific tools and technologies when identified and applied appropriately contribute to greener and more economical routes on large scale. Additionally, with the wealth of new reactions that continue to be discovered in the academic world, the field of process research toward organic compounds continues to remain dynamic, thus providing opportunities to develop green synthetic routes.
ABSTRACT: The pharmaceutical manufacturing industry faces the challenging task of operating sustainably with minimal safety, cost and environmental impact. While the ‘D’ part or process development in R&D is a very critical activity toward the scale-up of Active Pharmaceutical Ingredients (APIs) and intermediates, the ‘R’ part (process research) can also profoundly influence the API manufacturing industry; and it can be a deciding factor in the greenness of the process. The concept of Green Chemistry by Design (GCbD) enables one to understand the relationship between process research, sustainability and economics with respect to API. Proactively designing synthetic routes by recognizing criteria such as safety, environmental, legal, economics, control as well as throughput is an important step in the selection of a practical synthetic route. More often than not, a cost effective process is a green process. Existing and emerging scientific tools and technologies when identified and applied appropriately contribute to greener and more economical routes on large scale. Additionally, with the wealth of new reactions that continue to be discovered in the academic world, the field of process research toward organic compounds continues to remain dynamic, thus providing opportunities to develop green synthetic routes.
INTRODUCTION
The pharmaceutical industry has continued to go through major changes since its inception. More drugs than before continue to be discovered, developed and launched, benefiting the patient and thus reducing the burden of disease. While the advantages of this established and yet growing industry are undeniably obvious, the challenges that it continues to face are unique. Sustainable and efficient production of chemicals with the least impact on the environment remains a difficult task, given the various hurdles faced by the industry such as cost-effectiveness, regulatory, legal, robustness, “greenness” and safety. These changing times have stirred the industrial and academic scientific community to work toward developing better reactions and processes. Until recently, the development of green and environmentally friendly processes remained confined mostly to the innovator and generic pharmaceutical companies; while today the growing API business demands the same in pursuit of sustainability, cost-effectiveness and value addition for its customers.
The pharmaceutical industry has continued to go through major changes since its inception. More drugs than before continue to be discovered, developed and launched, benefiting the patient and thus reducing the burden of disease. While the advantages of this established and yet growing industry are undeniably obvious, the challenges that it continues to face are unique. Sustainable and efficient production of chemicals with the least impact on the environment remains a difficult task, given the various hurdles faced by the industry such as cost-effectiveness, regulatory, legal, robustness, “greenness” and safety. These changing times have stirred the industrial and academic scientific community to work toward developing better reactions and processes. Until recently, the development of green and environmentally friendly processes remained confined mostly to the innovator and generic pharmaceutical companies; while today the growing API business demands the same in pursuit of sustainability, cost-effectiveness and value addition for its customers.
A sustainable process for an intermediate or an API stems from an innovative, well-thought out and planned process R&D work based on the principles of Green Chemistry. The term E (environmental) factor, defined as the kilograms of waste per kilogram of product, was introduced as a measure of the environmental effect of a manufacturing process in various chemical businesses (1). While there are several other measurable terms and concepts in Green Chemistry, the E-factor remains widely used and represents the actual amount of waste produced in a chemical process (2). Compared to the other segments of the industry, the pharmaceutical and fine chemical industry generates significant waste per kilogram of product, mainly due to the complexity of the synthetic processes involved thus leading to higher E-factors. However, with the introduction of...In order to continue reading this article please register to our website – registration is for free and no fees will be applied afterwards to download contents.
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