SEM-VI

Immunoglobulins (Antibodies) and Their Structure

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Introduction to Immunoglobulins Immunoglobulins (Ig), commonly known as antibodies, are glycoprotein molecules produced by B-lymphocytes (B-cells) and plasma cells in response to the presence of antigens. They are essential components of the adaptive immune system, functioning as the humoral arm of immunity. Immunoglobulins are crucial for recognition, neutralization, and elimination of pathogens including bacteria, viruses, … Read more

Immunity: Humoral and Cellular Immunity

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Introduction to Immunity The term immunity is derived from the Latin word immunitas, meaning “freedom from” or “exemption.” In biological terms, immunity refers to the ability of a living organism to resist or eliminate invading infectious agents, foreign particles, and harmful substances. It is a complex, highly organized defense system involving a network of specialized … Read more

Polymerase Chain Reaction (PCR)

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1. Introduction The Polymerase Chain Reaction (PCR) is a groundbreaking molecular biology technique that enables the selective amplification of a specific DNA sequence from a tiny amount of starting genetic material. This technique was developed by Kary Mullis in 1983, for which he was awarded the Nobel Prize in Chemistry in 1993. PCR has revolutionized … Read more

Applications of Recombinant DNA Technology and Genetic Engineering

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Applications of Recombinant DNA Technology and Genetic Engineering in the Production of Interferon, Vaccines (Hepatitis B), and Hormones (Insulin) Introduction Recombinant DNA (rDNA) technology and genetic engineering have transformed modern medicine by enabling the large-scale production of therapeutic biomolecules that were once rare, costly, or difficult to extract from natural sources. By manipulating genetic material … Read more

Recombinant DNA Technology and Applications

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1. Introduction Recombinant DNA (rDNA) technology represents one of the most transformative advances in modern biological science. It involves the artificial recombination of genetic material from different sources to create new DNA sequences that can be inserted into host organisms for expression. This process allows scientists to modify the genetic blueprint of organisms, giving rise … Read more

Study of Cloning Vectors, Restriction Endonucleases, and DNA Ligase

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Introduction The field of genetic engineering and molecular biology has revolutionized the biological sciences, enabling scientists to manipulate genetic material for research, industrial, agricultural, and therapeutic applications. Central to this manipulation are three essential tools — cloning vectors, restriction endonucleases, and DNA ligase. Together, these molecular instruments form the backbone of recombinant DNA (rDNA) technology, … Read more

ISO 14000: Overview, Benefits, Elements, and Steps

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ISO 14000: Environmental Management Systems Overview of ISO 14000 The ISO 14000 series is a set of international standards and guidelines developed by the International Organization for Standardization (ISO), specifically focused on environmental management systems (EMS). These standards provide a structured framework for organizations to systematically manage and improve their environmental performance. The primary aim … Read more

ISO 9000: Overview, Benefits, Elements, steps for registration

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ISO 9000 is a series of internationally recognized standards that have been developed and published by the International Organization for Standardization (ISO) to guide organizations in establishing and maintaining effective quality management systems (QMS). These standards are based on universally accepted principles of quality assurance and management. The ISO 9000 family aims to help organizations … Read more

Quality by Design (QbD) in Pharmaceutical Development

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Definition Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. According to the ICH Q8 guideline: “QbD is a systematic approach to development that begins with predefined objectives and emphasizes product … Read more

ICH Stability Testing Guidelines (Q1 Series)

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Introduction Stability testing forms the backbone of pharmaceutical product development, ensuring that drug substances and drug products maintain their intended physical, chemical, biological, and microbiological properties throughout the proposed shelf life. The primary objective of stability testing is to furnish evidence on how the quality of a drug substance or product varies with time under … Read more