Monoclonal Antibody Process.pdf
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Monoclonal antibodies are antibodies that have a high degree of specificity (mono-specificity) for an antigen or epitope. Monoclonal antibodies are typically derived from a clonal expansion of antibody producing malignant human plasma cells. The initial monoclonal antibodies were created by fusing spleen cells from an immunized mouse with human or mouse myeloma cells (malignant self-perpetuating antibody producing cells), and selecting out and cloning the hybrid cells (hybridomas) that produced the desired antibody reactivity. These initial monoclonal products were mouse antibodies and were very valuable in laboratory and animal research and diagnostic assays, but were problematic as therapeutic agents because of immune reactions to the foreign mouse protein. Subsequently, production of chimeric mouse-human monoclonal antibodies and means of further “humanizing” them and producing fully human recombinant monoclonal antibodies were developed.
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These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
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These changes in the dermis and epidermis cause the typical desquamation of the stratum corneum observed in psoriasis. The psoriatic lesions indicate an inflammatory reaction caused by the secretion of pro-inflammatory cytokines from macrophages, lymphocytes, and neutrophils.
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methyl group in their chemical structure.
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Optimum performance laminar chromatography (OPLC ) , in a contrast , is a pumped flow chromatography system that uses a planar 2D column format .
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EDWARD JENNER conduct experiments in 1796 that lead to the creation of the first smallpox vaccine for prevention of smallpox.
A vaccine for RABIES is developed by LOUIS PASTEUR .
Vaccine for COLERA and TYPHOID were developed in 1896 and PLAGE vaccine in 1887.
The first DIPHTHERIA vaccine is developed in about 1913 by EMIL ADOLPH BEHRING,WILLIAM HALLOCK PARK.
The whole cell PERTUSIS vaccines are developed in 1914.
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It is adaptive defense system which is able to generate a variety of cell and molecules capable of specifically recognizing and eliminating a variety of limitless foreign invaders into the system.
In 1975 Georges Kohler and Milstein succeeded in making fusions of myeloma cell lines with B cells to create hybridomas that could produce antibodies.
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Also known as immunoglobulin is a large, Y shaped glycoprotein produced mainly by plasma cells that is used by the immune system to neutralize pathogens.
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Mass spectrometer provides information that aids in the identification and structural elucidation of each component.
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These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
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Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
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What is an experiment ?
An experiment refers to any process that generates a set of data.
An experiment involves a test or series of test in which purposeful changes are made to the input variables of a process or system so that changes in the output responses can be observed and identified.
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Containers are in intimate contact with the product. No container presently available is totally non reactive, particularly with aqueous solutions . Both the chemical and physical characteristics are given primary consideration in the selection of a protective container . Glass containers traditionally have been used for sterile products , many of which are closed with rubber stoppers. Interest in plastic containers for parenterals is increasing and such containers are being used for commercial ophthalmic preparations and IV solutions.
NMR- Diamagnetic Anisotropy and its effect on chemical shift
The shift in the position of the NMR region resulting from the shielding and deshielding by electrons is called chemical shift.
When a proton is present inside the magnetic field more close to an electro positive atom more applied magnetic field is required to cause excitation. This effect is called shielding effect.
When a proton is present outside the magnetic field close to a electronegative atom less applied magnetic field is required to cause excitation . This effect is called deshielding effect
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It is the process of finding the best way of using the existing resources while taking in to the account of all the factors that influences decisions in any experiment.
The objective of designing quality formulation is achieved by various optimization techniques.
In Pharmacy word “optimization” is found in the literature referring to study of the formula. In formulation development process generally experiments by a series of logical steps, carefully controlling the variables and changing one at a time until satisfactory results are obtained.
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Gene therapy is the modern techniques of treatment of various diseases and disorders.
Gene therapy is the introduction of genes into existing cells to prevent or cure a wide range of diseases.
It is a technique for correcting defective genes responsible for disease development.
Inactivating, or “knocking out,” a mutated gene that is functioning improperly.
The first approved gene therapy experiment occurred on September1990 in US, when Ashanti DeSilva was treated for ADA-SCID.
Under the direction of William French Anderson, at the National Institutes of Health (NIH),
Coupling vibration in IR(Infra Red) spectroscopy and their significance.
Introduction, Coupling vibration, Requirements for effective coupling, References.
coupling occurs in IR by stretching and bending vibration, symmetrical and asymmetrical stretching vibration.
Optimization techniques in formulation Development Response surface methodol...
The term “optimize” is “to make as perfect”. It is defined as follows: choosing the best element from some set of variable alternatives.
An art ,process ,or methodology of making something (a design system or decision ) as perfect ,as functional, as effective as possible .
Infrared spectroscopy IR
This document provides an overview of infrared spectroscopy. It discusses how infrared radiation interacts with molecules by causing vibrations between their atomic bonds. The absorption of infrared radiation depends on characteristics like the mass of the atoms in the bond and the stiffness of the chemical bond. Quantum mechanics describes the vibrational energy levels of molecules as discrete, quantized values. Even at absolute zero, molecules will possess a minimum vibrational energy called zero-point energy due to their quantum nature. Infrared spectroscopy can reveal information about molecular structure by examining their characteristic vibrational frequencies.
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CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
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Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
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11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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