This document provides guidelines for the development, production, characterization, and specifications of monoclonal antibodies and related products intended for human use. It covers quality requirements for monoclonal antibodies to be used as medicinal products, including guidelines for development of the monoclonal antibody, production considerations regarding platform manufacturing and viral safety, characterization of physicochemical, immunological and biological properties, and specifications. The document replaces previous guidelines on monoclonal antibodies and sets quality standards for marketing authorization of these products in Europe.
An introductory presentation (ppt) on biosimilars and guidelines related to their approval along with the challenges faced by biosimilar industries in India.
Biosensors, Types of Biosensors, Applications of Biosensors, Nanotechnology, Nanobiosensors, Components of Biosensor, Working of Biosensor, Principle of Biosensor, Examples of Biosensor, Advantages of Biosensor, Disadvantages of Biosensor, Limitations of Biosensor, Features of a Biosensor, Calorimetric Biosensors, Potentiometric Biosensors, Acoustic Wave Biosensors, Amperometric Biosensors, Optical Biosensors, Examples of a Nanobiosensor, Lab on a chip,
Applications of Lab on a chip, Glucose Biosensor
Mass Spectrometry-Based Proteomics Quantification: iTRAQ Creative Proteomics
For more information, please visit: https://www.creative-proteomics.com/services/itraq-based-proteomics-analysis.htm
iTRAQ (isobaric tag for relative and absolute quantitation), is an isobaric labeling method to determine the amount of proteins from different sources in just one single experiment by mass spectrometry, which was developed by Applied Biosystems Incorporation in 2004.
chimeric antigen receptor, its structure and role in killing tumor cells,mechanism of antitumor killing, car's in clinic,evolution of cars and new chimeric antigen models
This article is aimed at a brief introduction to phage display technology for production of single-domain Abs (dAbs), popularly also called ‘nanobodies’, and then to discuss their diagnostic applications.
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
An introductory presentation (ppt) on biosimilars and guidelines related to their approval along with the challenges faced by biosimilar industries in India.
Biosensors, Types of Biosensors, Applications of Biosensors, Nanotechnology, Nanobiosensors, Components of Biosensor, Working of Biosensor, Principle of Biosensor, Examples of Biosensor, Advantages of Biosensor, Disadvantages of Biosensor, Limitations of Biosensor, Features of a Biosensor, Calorimetric Biosensors, Potentiometric Biosensors, Acoustic Wave Biosensors, Amperometric Biosensors, Optical Biosensors, Examples of a Nanobiosensor, Lab on a chip,
Applications of Lab on a chip, Glucose Biosensor
Mass Spectrometry-Based Proteomics Quantification: iTRAQ Creative Proteomics
For more information, please visit: https://www.creative-proteomics.com/services/itraq-based-proteomics-analysis.htm
iTRAQ (isobaric tag for relative and absolute quantitation), is an isobaric labeling method to determine the amount of proteins from different sources in just one single experiment by mass spectrometry, which was developed by Applied Biosystems Incorporation in 2004.
chimeric antigen receptor, its structure and role in killing tumor cells,mechanism of antitumor killing, car's in clinic,evolution of cars and new chimeric antigen models
This article is aimed at a brief introduction to phage display technology for production of single-domain Abs (dAbs), popularly also called ‘nanobodies’, and then to discuss their diagnostic applications.
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)HadiaNaz1
EXECUTIVE SUMMARY OF ICH GUIDELINES Q5A (R1) AND Q4B ANNEX 2 (R1)
VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN – Q4B ANNEX 2 (R1):
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. The scope of the document covers products derived from cell cultures initiated from characterized cell banks. It covers products derived from in vitro cell cultures, recombinant DNA – derived products and also includes products derived from hybridoma cells grown in vivo.
Three principal approaches have evolved to control the potential viral contamination of biotechnology products:
a) Selecting & testing cell lines and other raw materials, including media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans.
b) Assessing the capacity of the production processes to clear infectious viruses.
c) Testing the product at appropriate steps of production for absence of contaminating infectious viruses.
The guideline suggests approaches for the evaluation of the risk of viral contamination and for the removal of virus from the product. Following are the recommended tests for the brief description of a general framework and philosophical background within which the manufacturer should justify the testing that was done;
1) Test for Retroviruses
2) In vitro Assay
3) In vivo Assay
4) Antibody Production Tests
TEST FOR EXTRACTABLE VOLUME OF PARENTRAL PREPARATIONS GENERAL CHAPTER – Q4B ANNEX 2 (R1):
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). The acceptance criteria of this document are same in the three pharmacopoeias.
The annex contains the following considerations for the implementation;
1) General Consideration
2) FDA Consideration
3) EU Consideration
4) MHLW Consideration
Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...Merck Life Sciences
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
-Potential risks associated with different areas of biotech processes
-What can be done to minimize adventitious virus risk in those areas.
The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...MilliporeSigma
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
-Potential risks associated with different areas of biotech processes
-What can be done to minimize adventitious virus risk in those areas.
The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
“Approaches to evaluation of various groups of biological products in Russia”
Provides an overview of the current assessment approaches applicable to biotherapeutics in the Russian Federation
“Challenges of biosimilar product development and experience gained”
Shows the development process for biosimilars, focusing specifically on the company’s experience
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.