Chapter 18: Immunological products

Author

Dr. Ramu Samineni  

Assistant Professor, School of Pharmacy, Joy University, Vadakangulam, Tamil Nadu, India

Abstract: Immunological products represent a specialized category of pharmaceuticals designed to stimulate, suppress, or modulate the immune system. This section explores various types of immunological products, including vaccines, immunoglobulins, and monoclonal antibodies. The principles of immunology underlying these products, such as antigen-antibody interactions and immune response mechanisms, are discussed. Vaccine development and production processes, including live attenuated, inactivated, and subunit vaccines, are examined in detail. The formulation considerations for immunological products, such as adjuvant selection, stabilization, and preservation, are addressed. Manufacturing processes specific to immunological products, including cell culture techniques, purification methods, and fill-finish operations, are explored. Quality control measures for immunological products, including potency assays, identity tests, and safety evaluations, are detailed. The challenges in developing and manufacturing immunological products, such as cold chain requirements and stability issues, are discussed along with mitigation strategies. Regulatory considerations specific to immunological products, including lot release requirements and post-marketing surveillance, are highlighted. Recent advancements in immunological product development, such as DNA vaccines and therapeutic cancer vaccines, are briefly explored to provide insight into future directions in this field.

Keywords: Vaccines, Antibodies, Immunomodulation, Adjuvants, Biological manufacturing, Potency assays

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