Valliappan Kannappan

Episode 4: Technology as Catalyst: How Science Enabled the Regulatory Transformation

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Tagline: “When scientific precision sharpened, so did regulatory vision -technology became the bridge between molecules and medicine.” Introduction The regulatory awakening around chiral drugs in the 1990s did not occur in isolation. It was powered, almost inevitably, by remarkable scientific and technological breakthroughs. Before sophisticated tools existed, distinguishing and isolating enantiomers was labor-intensive, error-prone, and prohibitively expensive. It was the advent of new chemical, analytical, and bioanalytical technologies that made the regulatory demands for stereochemical …

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Episode 3: Beyond Borders: Comparing How Global Agencies Regulate Chiral Drugs

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“Science may be universal, but regulation wears many faces. Let’s journey through the world of chiral drug approval across continents.” Introduction The 1990s witnessed a revolutionary shift in the regulatory treatment of chiral drugs, spurred by major agencies like the U.S. FDA and European Medicines Agency (EMA). However, the global regulatory landscape was -and still is -far from homogeneous. While scientific consensus around the importance of stereochemistry has largely been achieved, regulatory expectations, procedural details, …

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Episode 2: The Great Shift: How the 1990s Redefined Stereochemical Standards

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“When regulators caught up with science, a quiet molecular revolution began – changing the future of drug development forever.” Introduction The 1990s represent a pivotal decade in pharmaceutical regulation, where long-overlooked nuances of molecular chirality finally received the attention they deserved. Before this era, enantiomers in drug substances were treated as interchangeable entities, with few regulatory frameworks requiring detailed evaluation of each stereoisomer. However, accumulating scientific evidence, technological advances, and a few high-profile pharmaceutical tragedies …

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Episode 1: When Mirror Images Mattered: A Historical Prelude to Chiral Drug Regulation

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“Before the world looked closely at molecular mirror images, the pharmaceutical landscape was filled with blind spots -this is the story of how chirality found its voice.” Introduction The phenomenon of chirality, where molecules exist as non-superimposable mirror images, permeates the natural world. In biological systems, chirality is fundamental: proteins, enzymes, and receptors are inherently stereospecific, responding differently to the two mirror-image forms, or enantiomers, of a compound. In pharmacology, these subtle molecular differences can …

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Part 5. The Future of Chirality: Challenges and Innovations

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As the study of chirality enters its next phase, it remains at the forefront of scientific exploration, bridging disciplines such as chemistry, biology, pharmacology, and material science. The journey from its foundational discoveries to the transformative breakthroughs in asymmetric synthesis and pharmaceutical applications has established chirality as a fundamental concept in understanding and manipulating molecular asymmetry. This final chapter provides a holistic summary of chirality’s journey, its underpinnings, and where it is headed in the …

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P4. Catalysts of Change: Advancements in Asymmetric Synthesis

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Asymmetric synthesis is a cornerstone of modern chemistry, enabling the creation of enantiomerically pure compounds essential for pharmaceuticals, materials science, and biotechnology. From early challenges in chiral synthesis to groundbreaking innovations in catalysis, this chapter explores the transformative advancements in asymmetric synthesis, highlighting the scientists, their discoveries, and the profound impact on science and industry. The Challenge of Selectivity in Synthesis Synthesis of chiral compounds was once a formidable challenge. Early chemists struggled with racemic …

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P3. Chirality in Medicine: From Discovery to Disaster

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The intersection of chirality and medicine is a compelling narrative that reveals both the promise and peril of molecular asymmetry. From its earliest applications in pharmacology to the tragic consequences of overlooking enantiomeric differences, the role of chirality in medicine underscores the profound impact of stereochemistry on human health. This chapter delves into the breakthroughs, challenges, and lessons learned as chirality became a cornerstone of drug development. Early Discoveries: The Physiological Impact of Chirality The …

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P1. The Origins of Chirality: From Light to Life

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Lead Chirality – a concept rooted in the mirror-image asymmetry observed in nature – stands as a cornerstone of chemistry and pharmaceutical sciences. This journey begins in the early 19th century, where the interplay of physics, chemistry, and biology unveiled the mysterious world of chiral molecules. These pioneering explorations profoundly changed our understanding of molecular structures and their pivotal roles in biological and pharmaceutical applications. Étienne-Louis Malus: The First Step into the Polarized World In …

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The Future of Chiral Resolution: Green Chemistry and Sustainable Practices

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Lead Sustainability is becoming an increasingly important consideration across many industries, and chiral resolution is no exception. The separation of enantiomers, essential in pharmaceuticals, agrochemicals, and other sectors, has traditionally relied on methods that consume large amounts of energy, solvents, and other resources. As industries become more aware of the environmental impact of these processes, there is a growing movement toward more sustainable and eco-friendly practices in chiral resolution. 1. Why Sustainability is a Growing …

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Unconventional Approaches in Chiral Resolution: New Horizons

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Lead Chiral resolution has been an essential process in various industries, particularly pharmaceuticals, where separating enantiomers is critical for drug efficacy and safety. Traditional techniques such as chromatography, crystallization, and kinetic resolution have served as the backbone of chiral separation. However, these methods can be time-consuming, costly, and inefficient, especially at large scales. As industries evolve and demand for enantiopure compounds increases, there is a growing need for innovative and efficient methods of chiral resolution. …

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