Cervical cancer is caused by HPV types 16 and 18. Cervarix is a vaccine manufactured by GSK that aims to prevent HPV infections from these types through recombinant L1 proteins produced in insect cells and an adjuvant. It has shown 92% efficacy over 4 years. Cervarix has grown to over $1 billion in annual sales through 2014 with extensive quality control during its manufacturing process.
This presentation contains 45 slides on general virology comprises of topics on viral classification, transmission, pathogenesis, viral cytopathic effect, stages of viral infections, antiviral drugs and viral vaccines. It also have a slide noting an outline of laboratory diagnosis of viral infection. This power point presentation was designed for medical students, nurses and academicians teaching virology and microbiology in medical universities, schools or colleges.
ELISA Vs ELISPOT - Principle, Procedure, Advantagesajithnandanam
The Enzyme Linked Immunospot (ELISPOT) technique was developed by Cecil Czerkinskdy in 1983. ELISPOT is used for the detection of secreted proteins, such as cytokines and growth factors. ELISPOT is primarily used in immunology research in the following areas:
Slideshow is from the University of Michigan Medical
School's M1 Infectious Disease / Microbiology sequence
View additional course materials on Open.Michigan:
openmi.ch/med-M1IDM
VLP that is virus like particle is one of the emerging medicine in the field of vaccines.It is interesting to see the facts about the progress and possibilities of the same.
This presentation contains 45 slides on general virology comprises of topics on viral classification, transmission, pathogenesis, viral cytopathic effect, stages of viral infections, antiviral drugs and viral vaccines. It also have a slide noting an outline of laboratory diagnosis of viral infection. This power point presentation was designed for medical students, nurses and academicians teaching virology and microbiology in medical universities, schools or colleges.
ELISA Vs ELISPOT - Principle, Procedure, Advantagesajithnandanam
The Enzyme Linked Immunospot (ELISPOT) technique was developed by Cecil Czerkinskdy in 1983. ELISPOT is used for the detection of secreted proteins, such as cytokines and growth factors. ELISPOT is primarily used in immunology research in the following areas:
Slideshow is from the University of Michigan Medical
School's M1 Infectious Disease / Microbiology sequence
View additional course materials on Open.Michigan:
openmi.ch/med-M1IDM
VLP that is virus like particle is one of the emerging medicine in the field of vaccines.It is interesting to see the facts about the progress and possibilities of the same.
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins.
The hepatitis B virion (Dane particle):
outer lipid envelope with the surface antigen (HBsAg).
an electron-dense core (nucleocapsid): ds circular DNA and polymerase surrounded by the core antigen (HBcAg).
The HBsAg is produced in excess by the infected hepatocytes and is secreted in the form of spherical
and filamentous particles.
This presentation contains 53 power point slides. These slides have description between virus and host cell interactions including concept of permissive and non-permissive infection, latent infection and host immune response to viral infection. Slides are designed for medical students, nurses, academicians who are teaching virology and microbiology in medical universities, schools or college.
Detection and Characterization of Pathotypes, Serotypes, Biotypes, Phenotypes...Bhoj Raj Singh
This presentation of my lecture, to Epidemiology students, briefs about different methods for differentiating or finding similarities among isolates of pathogens required establishing causal associations in epidemiological disease diagnosis.
Overview of vaccine and vaccination, types of vaccines with examples, vaccine production technique, adverse effects of vaccination, precautions
Email: jeevan@smail.nchu.edu.tw
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins.
The hepatitis B virion (Dane particle):
outer lipid envelope with the surface antigen (HBsAg).
an electron-dense core (nucleocapsid): ds circular DNA and polymerase surrounded by the core antigen (HBcAg).
The HBsAg is produced in excess by the infected hepatocytes and is secreted in the form of spherical
and filamentous particles.
This presentation contains 53 power point slides. These slides have description between virus and host cell interactions including concept of permissive and non-permissive infection, latent infection and host immune response to viral infection. Slides are designed for medical students, nurses, academicians who are teaching virology and microbiology in medical universities, schools or college.
Detection and Characterization of Pathotypes, Serotypes, Biotypes, Phenotypes...Bhoj Raj Singh
This presentation of my lecture, to Epidemiology students, briefs about different methods for differentiating or finding similarities among isolates of pathogens required establishing causal associations in epidemiological disease diagnosis.
Overview of vaccine and vaccination, types of vaccines with examples, vaccine production technique, adverse effects of vaccination, precautions
Email: jeevan@smail.nchu.edu.tw
Business law : Intellectual property right: Patents, trademarks, geographical...Renzil D'cruz
Business law presentation on Patents, trademarks, geographical indications As a part of Intellectual property right With relevant provision of WTO also this Presentation covers case study on Apple vs Samsung case, Viagra Patent issue,Basamati rice, Darjeeling tea etc.
Definition of fermentation, Range of fermentation process, Chronological development of the fermentation industry, components parts of a fermentation process.
Plasmid Manufacturing Service from GenScript ProBioGenScript ProBio
GenScript ProBio offers the best Plasmid Manufacturing Service and employs a GMP-compliant plasmid production process that allows customers to replicate DNA used in experiments with minimal additional effort. By employing this process, Genscript can provide plasmids produced at the highest quality standards. For more information, visit our website. https://www.genscriptprobio.com/gct-proplasmid.html
The core principle behind mRNA as a technology for vaccination is to deliver the transcript of interest, encoding one or more immunogen(s) into the host cell cytoplasm where expression generates translated protein(s) are ultimately located in the membrane, to be secreted, or intracellular. Two categories of mRNA constructs are being evaluated: non-replicating mRNA (NRM) and self-amplifying mRNA (SAM).
https://www.creative-biolabs.com/lipid-based-delivery/
Gene editing in veterinary vaccine development: Status of the scienceILRI
Presentation by Lucilla Steinaa at a CGIAR webinar on 'Genome Editing in Agriculture: Innovations for Sustainable Production and Food Systems', 6 October 2020.
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.
Abstract:
Cell and gene therapies, well recognized as the drug revolution for this decade, are booming in Asian countries. Several cell and gene therapeutic products launched successfully in Europe and the US. The commercialization of these therapies is a hot topic, while ensuring product safety, especially quality for the new modalities, raises challenges within the industry. As a globally leading biosafety testing provider, Merck is committed to optimizing and advancing innovation and development of biosafety testing. As your reliable partner in CMC consideration, our comprehensive solutions for cell and gene therapy biosafety testing enable regulatory compliance. This presentation will cover rationale and methodologies for cell and gene therapy product testing from Merck’s BioReliance® testing portfolio, as well as provide an overview of our testing capabilities and services.
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
Mycotoxins are a major hazard to humans and animals, often being found in a wide range of food and feed samples and causing cancer as a result of ingestion of contaminated commodities.
Johne's disease (JD) or Paratuberculosis (PTB) has gained a great attention by many industrial countries for its severing economic losses and possibly zoonotic concerns. In the current study conventional clinical and direct microscopic examination compared to real time polymerase chain reaction (RT-PCR) were used to diagnose JD in clinically suspected small ruminants. Clinical examination revealed 130 (8.7%) suspected cases that showed history of emaciation and diarrhea out of the total examined (1500) animals. Direct microscopy of Ziehl-Neelsen (ZN) stained smears (130) revealed 62 (47.7%) acid fast bacteria resembled Mycobacterium avium subsp. paratuberculosis (MAP). RT-PCR insertion sequence gene (IS900) detected MAP in 25 (65.8%) out of 38 fecal samples harbored acid fast bacilli. We concluded and recommended that RT-PCR considers the most rapid confirmatory method for screening and diagnosis of the MAP in comparison to low specific conventional phenotypic methods, which still remained valuable techniques in the diagnosis of JD in developing countries.
Key-words: Johne's disease, Paratuberculosis, Acid fast bacteria, Ziehl-Neelsen stain, IS900 gene
Grains are a group of foods that includes maize, oats, barley, wheat, rye, sorghum and others. As widely reported, grain products are divided into two categories: refined and whole grain. The earlier is achieved by food manufacturers through milling, whereby the germ, bran and the endosperm are removed. The latter is just the whole grain itself. Grain milling is the milling of flour and rice; the malting of grain (primarily barley); and the mixing of prepared flour mixes and dough. Maize, rice and wheat constituted 87 percent of all grain production worldwide and 43 percent of food calories in 2003.
Oncolytic Virus Therapy Development - Creative BiolabsCreative-Biolabs
Oncolytic virotherapy is cancer treatment using a native or reprogrammed virus that has the potential to targeting and killing cancerous cell. Taking advantage of the OncoVirapy™ platform, Creative Biolabs provides customized, standardized, and reliable and high-quality oncolytic virus therapy development services for clients globally.
Production and purification of Viral vectors for gene and cell therapy appli...Dr. Priyabrata Pattnaik
Presentation at "2016 Osong BioExcellence - Renaissance in Immunotherapy" at South Korea, an event jointly hosted by Kbio Health and Merck on 6th October 2016.
Steve Berger - Manufacturing & Development UpdateJohn Blue
Manufacturing & Development Update - Steve Berger, Development Director, Aptimmune, from the 2018 Aptimmune Pre-AASV Symposium, March 2, 2018, San Diego, CA, USA.
More presentations at http://www.swinecast.com/2018-aptimmune-symposium-aasv
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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.
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.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
2. • Cervical Cancer & HPV
• Cervarix (HPV vaccine)
• The Manufacturing process
• Quality Control
• Conclusion
3. • Cervical cancer is a malignant neoplasm of the
cervix uteri or cervical area.
• Worldwide, it is the twelfth most common and
fifth most deadly cancer in women.
• It affects about 16 per 100,000 per year and kills
about 9 per 100,000 per year globally.
4.
5. • Cervarix is a preventive vaccine against certain
types of cancer causing human papillomavirus.
• Manufactured at GlaxoSmithKline Biologicals S.A. in
Belgium.
• Aims to prevent infection from HPV types 16 & 18 that
cause about 70% of cervical cancer cases.
• Developed, in parallel, by researchers at Georgetown
University Medical Center, the University of Rochester, the
University of Queensland Australia and the US National
Cancer Institute
6. • Approved for use in females 10-25 years of age.
• Consists of 3 doses of 0.5 mL each, by intramuscular
injection at 0, 1 and 6 months.
• The vaccine is available in 0.5 mL single dose vials and
prefilled TIP-LOK syringes
• Cervarix has shown to be 92% effective and effective for
more than 4 years.
• Shelf life: 3 years.
7. Cervical cancer vaccine Annual Sales World Wide ($m)
sales
Product Company 2008 2010 2012 2014
Gardasil Sanofi-Pasteur 865 1,222 1,686 1,984
MSD
Gardasil Merck & Co 1,403 1,227 1,399 1,372
Cervarix GlaxoSmithKlin 231 797 1,246 1,353
e
Total HPV vaccine market 2,499 3,246 4,331 4,709
Adapted from GSK: 2010 Annual Report, Sanofi 2009 Annual
Report
9. • Cervarix, HPV-16/18 L1 AS04 vaccine contains
recombinant C-terminally truncated major capsid L1
proteins of HPV types 16 and 18 as active ingredients
• The first vaccines for humans from Baculovirus
Expression System
10. • The L1 proteins of HPV-16 and HPV-18 are
separately produced
• Usage of a:
recombinant Baculovirus expression system
insect cell line Hi-5 Rix4446 derived from Trichoplusia ni
11. • High levels of heterologous gene expression
• Grows well in suspension cultures, easy for large-
scale production
• Safe (restricted to infection of invertebrate species)
• Cheaper as Hi-5 Rix4446 can be cultured in serum
free medium
12.
13. Amplification of Seed Recombinant
Formulation, filling and packaging
Baculovirus
Extraction of Recombinant Combination of HPV 16 and 18 L1
Baculovirus inocula proteins
Infection of Trichoplusia ni Hi-5
Sterile filtration of L1 VLP
production cell lines in fermenter
Purification by
L1 proteins are extracted by
chromatography, nanometric
methods of osmotic shock
filtration and ultrafiltration
14. • The cell lysate may be subjected to a microfiltration
and ultra-filtration process
• Cation- exchange chromatogrophy
• Hydroxyapatite Chromatography
- hydroxyapatite as the column medium
- elution with a buffer solution containing phosphate anion
- removes a large amount of contaminants from a partially
purified cellular lysate
- Removes contaminating biomolecules, including
DNA, lipids and proteins are removed from the lysate.
15. • The L1 proteins
• AS04 adjuvant system composed of
- aluminium hydroxide
- 3-O-desacyl-4.- monophosphoryl lipid A (MPL)
• The MPL immunostimulant
- a detoxified derivative of the lipopolysaccharide of
the gram negative bacterium Salmonella minnesota
R595 strain.
16. CELL SEED AND BANKING
• The MCB, WCB, MS and WS and End of Production
Cells (EPC) are tested for identity, purity and safety
• The Assays are:
– Tumourogenic Potential
– Adventitious Agents
– Genetic Stability
– Specific Viral Contaminants
17. PROCESS CONTROL & VALIDATION
• The 3 unit-steps of the drug substance production process
are tested for consistency:
– The recombinant HPV-16/18 baculovirus inoculum
production process
– The L1 single harvest production and L1 extraction
– The L1 antigen purification process.
MANUFACTURING PROCESS DEVELOPMENT
• the final process purified bulks, are assessed by subjecting
each type of materials to a series of physico-chemical
analyses and immunogenic property tests.
18. Physico-Chemical Analyses Immunogenic Properties
• SDS-PAGE • Antigenic activity
• Western blotting
• Capillary electrophoresis
• Binding to polyclonal sera
• Mass spectrometry • Immune response elicited in
• Amino acid analysis mice
• Peptide mapping
• N-and C-terminal analysis
• Infra-Red and circular
dichromism spectroscopy
• Size exclusion chromatography
• Electron microscopy
• Disc centrifugation size
analysis
19. • Cervarix is a vaccine that prevents infection
from HPV types 16 and 18
• Market
• Manufacured and purified from expression of
L1 proteins in the Hi-5 Rix4446 insect cells
Editor's Notes
-Neoplasm: abnormal mass of tissue.
- Background of the vaccine
-Mainly targeted at young girls who havent started having sex.
Cervarix was EU approved in 2007 and the EU is currently its largest market. In 2009 Cervarix was approved by the FDA but sales forecasts anticipate limited market penetration, which is unsurprising given that Merck and Co’s Gardasil came to market 3 years earlier.However, entering the US market, world’s biggest drug market, is an important endorsement for a product that is judged to be Glaxo’s biggest individual sales growth driver over the next six years.Gardasil game to the global market a year before Cervarix, hence its higher annual sales.But the HPV vaccine market is predicted to almost double between 2008-2014 and because GSK is already established in emerging markets it is forecast to capture a larger segment
One dose of Cervarix, contains 20μg of HPV-16 L1 and 20μg of HPV-18 L1 proteins adjuvanted with AS04 and is presented as a sterile turbid liquid suspension for injection, filled as a 0.5ml monodose in either syringes or vials stored at 2-8°C. A shelf life of 3 years is proposed. The vaccination schedule includes 3 doses administered at 0, 1, and 6 months intramuscularly.
High-Five cells are egg cells from Trichoplusiani. These cells are less expensive to maintain since they may be grown without fetal calf serum.All three cells lines may be grown at room temperature (optimum = 25 - 27°C), and do not require CO2 incubators. Their doubling time is 18-24 hours
Several features make the Baculovirus Expression Vector System attractive for researchers: - High levels of heterologous gene expression are often achieved compared to other eukaryotic expression systems, particularly for intracellular proteins. In many cases, the recombinant proteins are soluble, post-translationally modified and easily recovered from infected cells late in infection when host protein synthesis is diminished.-The cell lines used for AcMNPV propagation grow well in suspension cultures, permitting the production of recombinant proteins in large-scale bioreactors.- Expression of hetero-oligomeric protein complexes can be achieved by simultaneously infecting cells with two or more viruses or by infecting cells with recombinant viruses containing two or more expression cassettes.- Baculoviruses have a restricted host range, limited to specific invertebrate species. They are safer to work with than most mammalian viruses since they are noninfectious to vertebrates.
http://www.jci.org/articles/view/22674/figure/3The HPV major capsid protein L1 can fold correctly and self-assemble into VLPs when expressed in eukaryotic cells. VLPs aim to protect against the development of cervical cancer; protection would be mediated by the induction of high titres of neutralizing antibodies against the HPV genotypes in the vaccine that prevent the virus infecting the transformation zone, a metaplastic area between the squamous and columnar epithelia in the cervix, where most cancers arise.The L1 proteins of HPV-16 and HPV-18 areseparately produced using a recombinant Baculovirus expression system and the insect cell line Hi-5Rix4446 derived from Trichoplusiani.The Baculovirus Expression Vector System is based on the introduction of a foreign gene into nonessential for viral replication genome region via of homologous recombination with a transfer vector containing target gene. The resulting recombinant Baculovirus lacks one of nonessential gene (polh, v-cath, chiA etc.) replaced with foreign gene encoding heterologous protein which can be expressed in cultured insect cells and insect larvae.
These proteins are produced in separate production runs using the Baculoviruses expression vector system (BEVS) using GSK´s insect cell line cloned from the Hi-5 Trichoplusianiinsect cell line and HPV-16 L1 or HPV-18 L1encoding recombinant Baculoviruses. Following expression the L1 proteins are purified by a series of chromatographic and filtration procedures and are finally assembled into (VLP) closely resembling the configuration of native HPV virus particles.First, recombinant baculovirusinocula of each serotype are prepared by amplification of the respective working seeds in the Hi-5 insect cell cultures.Next, these inocula are used for the infection of Hi-5 production cell culturesL1 protein is released from the cells by osmotic shockOsmotic shock or osmotic stress is a sudden change in the solute concentration around a cell, causing a rapid change in the movement of water across its cell membrane. Alternatively, at low concentrations of solutes, water enters the cell in large amounts, causing it to swell and either burst or undergo apoptosis
. Virtually any commercially available hydroxyapatite column material may be used in this invention. It is preferable to use a ceramic hydroxyapatite which a particle size of approximately 20-50 .mu.m and approximately an 800 .ANG. pore size. One such commercially available hydroxyapatite is sold by BioRad as "Ceramic hydroxyapatite, Type II". However, others are effective as well.In preparing the chromatography step of the purification process, it is recommended that the column feed be in a buffer with a pH of 6-8, and preferably approximately 7. A preferred buffer is 50 mM MOPS [3-(N-morpholino)propanesulfonic acid] ata pH of 7.0 and also containing 1.25 M NaCl.The partially purified VLPs in the buffered solution is allowed to come into contact with the hydroxyapatite medium under conditions which allow the VLPs to bind to the hydroxyapatite. These conditions include a broad temperature range; roomtemperature is preferred. Flow rate may also vary greatly, and a preferred range is approximately 90 cm/hour.After the VLPs are bound to the hydroxyapatite, the next step is recovery of the purified VLPs from the hydroxyapatite with an elution buffer. A preferred elution buffer solution contains a phosphate anion, such as a sodium or potassiumphosphate solution. Preferred molar ranges are from about 0.05 M to about 1 M, with approximately. 0.2 M being preferred. The pH of the elution buffer should range from about pH 6-8, with a pH of about 7 being preferred.Other advantages of the method of this invention include: (a) no requirement for special chromatography equipment and techniques; (b) the method is rapid, requiring no buffer changes; and (c) the method provides an excellent yield of HPV L1.
The Hi-5 Rix4446 insect cell line is examined for the presence of adventitious agents.
The capacity of the individual steps of the purification cascade to efficiently eliminate viral contaminants has been demonstrated in viral clearance studies.