This document summarizes a study evaluating multiple biomarkers for early detection of ovarian cancer. The study found that a panel of 6 biomarkers (prolactin, leptin, osteopontin, insulin-like growth factor II, macrophage inhibitory factor, and CA125) measured using a multiplex platform identified ovarian cancer with 95.3% sensitivity and 99.4% specificity, outperforming the individual markers and a 4-marker ELISA. The panel correctly classified most early stage cancers and had low rates of misclassification of healthy and benign samples. The results support further evaluation of this biomarker panel for early ovarian cancer screening.
Comparison of the Roche AMPLICOR® Human Papillomavirus (HPV) Test with the GP...guest8b7e21d
Both the Roche AMPLICOR HPV Test and the GP5+/GP6+ PCR assay can detect HPV in cervical samples. The AMPLICOR test detects 13 high-risk HPV types while GP5+/GP6+ detects both high-risk and low-risk types. Both tests performed well on samples stored in liquid cytology media or from archived tissues. They identified the same CIN2/CIN3 samples except for two discrepancies. The AMPLICOR test may have higher analytical sensitivity for low viral loads but clinical sensitivity requires more study. Both tests can be used for HPV detection in cervical screening.
Main file> http://www.slideshare.net/rustradeESP/testgene
TestGene develops and manufactures kits for molecular genetics. Products are intended for use in research, practical medicine, and in the fields of molecular biology. The focus area – non-invasive genetic testing in obstetrics and oncology. The company has its own production laboratory with the necessary equipment for manufacturing and quality assurance of kits based on "real time PCR".
Setting up for successful lot release testing by Edmund AngMilliporeSigma
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Setting up for successful lot release testing by Edmund AngMerck Life Sciences
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
The document discusses regulatory requirements for clinical laboratories in the United States under the Clinical Laboratory Improvement Amendments (CLIA). It covers the federal agencies that oversee CLIA, how tests are categorized based on their complexity, quality control and quality assurance procedures required by CLIA, and the role and responsibilities of the laboratory director. The document also provides an overview of how to establish a CLIA-certified laboratory, including quality management systems, method validation, and other regulatory requirements.
Use of rapid quality control test methods as alternatives to traditional meth...Merck Life Sciences
Abstract:
As the market for advanced therapy medicinal products (ATMP) matures the complexities of these molecules are evident and challenging when routine standard quality control (QC) testing is applied. Short shelf life from the point of manufacture to administration to the patient results in relatively low volumes for small scale clinical trials or small patient populations. Within a limited time period and with this low product volume, it is necessary to complete required regulatory QC testing, be that for early or late phase clinical trials, or for licensed drug product in a reduced timescale. So, the challenges with QC testing of cell and gene therapies using traditional test methods is time to results, due to short shelf-life, and availability of sufficient sample, due to low production volumes. Over the past years the application of rapid testing of short-life cell and gene therapies that may also help conserve limited product availability have been utilised. Regulatory expectations for using rapid test methods in place of classical or compendial test methods have been defined and this presentation will provide examples and data from our own experience of a range of alternate methods for application to ATMP products.
This document discusses the application of clinical proteomics in disease diagnosis and biomarker discovery. It provides an overview of how proteomics methodologies like mass spectrometry and protein microarrays can be used to identify protein biomarkers for various diseases from body fluids. Specific examples are given of proteomics studies that have discovered protein biomarker patterns or specific proteins that can improve diagnosis of cancers like colorectal cancer and breast cancer compared to single biomarkers. Biomarkers identified for other diseases like Alzheimer's disease and diabetic nephropathy through proteomics are also summarized.
Comparison of the Roche AMPLICOR® Human Papillomavirus (HPV) Test with the GP...guest8b7e21d
Both the Roche AMPLICOR HPV Test and the GP5+/GP6+ PCR assay can detect HPV in cervical samples. The AMPLICOR test detects 13 high-risk HPV types while GP5+/GP6+ detects both high-risk and low-risk types. Both tests performed well on samples stored in liquid cytology media or from archived tissues. They identified the same CIN2/CIN3 samples except for two discrepancies. The AMPLICOR test may have higher analytical sensitivity for low viral loads but clinical sensitivity requires more study. Both tests can be used for HPV detection in cervical screening.
Main file> http://www.slideshare.net/rustradeESP/testgene
TestGene develops and manufactures kits for molecular genetics. Products are intended for use in research, practical medicine, and in the fields of molecular biology. The focus area – non-invasive genetic testing in obstetrics and oncology. The company has its own production laboratory with the necessary equipment for manufacturing and quality assurance of kits based on "real time PCR".
Setting up for successful lot release testing by Edmund AngMilliporeSigma
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Setting up for successful lot release testing by Edmund AngMerck Life Sciences
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
The document discusses regulatory requirements for clinical laboratories in the United States under the Clinical Laboratory Improvement Amendments (CLIA). It covers the federal agencies that oversee CLIA, how tests are categorized based on their complexity, quality control and quality assurance procedures required by CLIA, and the role and responsibilities of the laboratory director. The document also provides an overview of how to establish a CLIA-certified laboratory, including quality management systems, method validation, and other regulatory requirements.
Use of rapid quality control test methods as alternatives to traditional meth...Merck Life Sciences
Abstract:
As the market for advanced therapy medicinal products (ATMP) matures the complexities of these molecules are evident and challenging when routine standard quality control (QC) testing is applied. Short shelf life from the point of manufacture to administration to the patient results in relatively low volumes for small scale clinical trials or small patient populations. Within a limited time period and with this low product volume, it is necessary to complete required regulatory QC testing, be that for early or late phase clinical trials, or for licensed drug product in a reduced timescale. So, the challenges with QC testing of cell and gene therapies using traditional test methods is time to results, due to short shelf-life, and availability of sufficient sample, due to low production volumes. Over the past years the application of rapid testing of short-life cell and gene therapies that may also help conserve limited product availability have been utilised. Regulatory expectations for using rapid test methods in place of classical or compendial test methods have been defined and this presentation will provide examples and data from our own experience of a range of alternate methods for application to ATMP products.
This document discusses the application of clinical proteomics in disease diagnosis and biomarker discovery. It provides an overview of how proteomics methodologies like mass spectrometry and protein microarrays can be used to identify protein biomarkers for various diseases from body fluids. Specific examples are given of proteomics studies that have discovered protein biomarker patterns or specific proteins that can improve diagnosis of cancers like colorectal cancer and breast cancer compared to single biomarkers. Biomarkers identified for other diseases like Alzheimer's disease and diabetic nephropathy through proteomics are also summarized.
Identifying novel and druggable targets in a triple negative breast cancer ce...Thermo Fisher Scientific
In this study, we developed a CRISPR/Cas9-based high throughput loss-of-function screen for identifying target genes responsible for the tumor proliferation and growth in TNBC. Our initial focus was to identify essential kinases in MDA-MB-231 cell line using the Invitrogen™ LentiArray™ Human Kinase CRISPR Library, which targets 840 kinases with up to 4 different gRNAs per protein kinase for complete gene knockout. This functional screen identified over 90 protein kinases that are essential for cell viability and cell proliferation. Ten of these hits (CDK1, CDK2, CDK8, CDK10, CDK11A, CDK19, CDK19, CDC7, EPHA2 and WEE1) are well-known targets validated in the literature. Currently, we are in the process validating the novel hits through target gene sequencing, western blotting and target specific small molecule kinase inhibitors.
Screening Tests for Toxic Chemicals: An OverviewJoseph Holson
This document provides an overview of screening tests for toxic chemicals. It defines screens as simplified tests designed to identify agents requiring further evaluation or exclude them from further testing. Key purposes of screens include economic savings, increased speed and number of chemicals evaluated while decreasing animal use. Screens must be valid, sensitive, reproducible and practical. The document discusses criteria for validation and acceptance of new testing methods and provides examples of in vitro and in vivo screens used in toxicology. It also discusses how screens fit within the regulatory testing structure and notes some limitations of screens in fully characterizing toxicity.
This document provides guidelines for laboratory diagnosis of Chlamydia trachomatis infections in East European countries. It discusses sample collection and transport, diagnostic methods including culture, antigen detection, nucleic acid amplification tests, and considerations for implementing and interpreting these tests. Commercial nucleic acid amplification tests are highlighted but caution is given around using non-approved tests.
Dancey Clinical Trials Vancouver Dancey 20110302 Final.Ppt [Compatibility Mode]Warren Hamilton
High content clinical trials involve dense sample collection and complex analyses from small patient numbers. They are important for early drug development and evaluation, addressing biological questions about target and pathway inhibition. Successful high content trials require standardized assays and infrastructure across sites, as well as collaboration between multiple institutions. Challenges include developing new science and technologies, building collaborative partnerships, and establishing operational and informatics systems for specimen and data management.
A blood protein marker for the early detection of pre- eclampsia Priyesh Waghmare
The document describes a proposed diagnostic device for the early detection of pre-eclampsia. The device would use a one-step, 15 minute test to measure levels of three biomarkers (PlGF, sflt-1, sEng) in blood to screen pregnant women in their first trimester. Current diagnosis methods are time-consuming and have high rates of false positives. The proposed device aims to provide a simple, rapid, inexpensive and early screening with high sensitivity and specificity to address the market need for improved pre-eclampsia detection.
This study analyzed omics data from over 70 breast cancer cell lines to develop predictive signatures of drug response. Pretreatment measurements included mRNA expression, copy number, protein expression, gene mutations, and transcriptome and methylation assays. Machine learning algorithms were used to identify associations between biological responses to therapy and pretreatment signatures. The developed signatures could predict drug response probabilities and help inform precision treatment recommendations for breast cancer patients. However, cell lines do not capture the full tumor microenvironment impacting response.
PREDICTIVE AND DIAGNOSTIC BIOMARKERS FOR OVARIAN CANCERDr. Girija Wagh
OVARIAN CANCER HAS ELUDED SCREENING AND EARLY DETECTION . SEVERAL BIOMARKERS ARE PROPOSED AND HERE IS A AN UPDATED REVIEW OF WHAT EXISTS IN THE CURRENT CLIMATE FOR THE SAME Ovarian carcinomas relate to highest death rate in gynecologic malignancies as absence of symptoms shield the disease in the early stage. Current evidences have been devoted to discovering early effective screening mechanism prior to the onset of clinical symptoms.Serum biomarkers may aid in the diagnosis of Early ovarian cancer
Distinguish malignant from benign disease
Prevent unnecessary surgery
Improve rates of early detection. Prof Girija Wagh is the Head of the Department of OBG at Bharati University Medical College and Hospital and a well acknowledged teacher and a researcher.This overview will certainly help the learners to approach this condition with more promise
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
This document discusses biomarkers for assessing immune function throughout the drug development process. It describes how various techniques can be used to identify, validate, and qualify biomarkers. These include flow cytometry to analyze cell populations and activation markers, Luminex to measure cytokine levels, and gene expression profiling using NanoString. Whole blood stimulation assays are discussed as a way to assess target engagement and immune responses ex vivo. The importance of assay validation and understanding sources of variation are also covered. Biomarkers can provide insights into mechanisms of action, safety, and efficacy to support clinical development.
Tumour Markers are substances present in the tumour, produced by the tumour or by the host as a response to the presence of the tumour, providing information about biological characteristics of the tumour. these tumour markers may specific for the tissue but often get elevated in neoplastic as well non-neoplastic lesions, further Various analytical platforms available for serum tumour markers lack standardisation. These factors add to interpretative challenges in serum tumour markers
Susan Cho Hicks has over 20 years of experience in clinical laboratory operations and management, specializing in molecular diagnostics and next generation sequencing. She currently serves as the Associate Director of Laboratory Operations at Sequenom Laboratories, where she oversees daily operations, quality management, and expansion of the non-invasive prenatal testing laboratory. Prior to this, she held various clinical laboratory roles with increasing responsibility at other companies developing technologies in oncology and infectious disease testing.
This document summarizes a presentation on non-invasive prenatal testing (NIPT). The presentation describes the history and current techniques used for NIPT, including analyzing cell-free fetal DNA from maternal plasma using massively parallel sequencing. It reviews the performance of NIPT in detecting common trisomies like Trisomy 21, with detection rates over 99% and low false positive rates. The presentation discusses the potential for NIPT to be expanded to more conditions and become a primary screening for all pregnancies.
Lesi Prakanker - Dr. dr. Poedjo Hartono, SpOG(K)pogisurabaya
This document discusses various methods for early detection of cervical cancer, including the Pap smear test and its limitations. It describes the Pap smear as the gold standard screening method but notes it has false negative and positive rates of 42% and limitations with specimen collection and analysis. The document summarizes alternative screening methods like ThinPrep, HPV testing, visual inspection with acetic acid, and a computer-assisted screening method called PapNet. It also provides details on cervical cancer classifications systems like The Bethesda System and explains concepts like ASCUS, LGSIL, HGSIL, and adenocarcinoma.
This document discusses a presentation on microbiome identification and characterization technologies. It begins with an introduction to the human microbiome and catalogs our "second genome". It then discusses how technologies like 16S rRNA sequencing and metagenomics have unlocked the ability to study the microbiome. Population studies of microbiome composition and disease associations are also reviewed. The presentation goes on to provide examples of how to design assays to identify and profile relevant microbiome targets, and discusses solutions for identification and profiling in microbiome research.
Vaccine Cell Bank and Virus Seed CharacterizationMilliporeSigma
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
- new technologies for determining the identity of cell substrates and virus seed stocks
- detecting adventitious agent contamination
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
- new technologies for determining the identity of cell substrates and virus seed stocks
- detecting adventitious agent contamination
Illumina is a leader in genomics technologies that provide reliable answers to guide reproductive and genetic health choices. Their portfolio includes technologies for preimplantation genetic screening and diagnosis, non-invasive prenatal testing, cytogenetics, carrier screening, and identifying inherited conditions. These solutions deliver accurate information through next-generation sequencing and microarrays to empower informed choices and transform lives along the healthcare continuum.
Website pdspatklinsby ini dibuat untuk berbagi ilmu dan informasi patologi klinik, serta menerima kritik dan saran untuk perbaikan website yang belum sempurna.
Identifying novel and druggable targets in a triple negative breast cancer ce...Thermo Fisher Scientific
In this study, we developed a CRISPR/Cas9-based high throughput loss-of-function screen for identifying target genes responsible for the tumor proliferation and growth in TNBC. Our initial focus was to identify essential kinases in MDA-MB-231 cell line using the Invitrogen™ LentiArray™ Human Kinase CRISPR Library, which targets 840 kinases with up to 4 different gRNAs per protein kinase for complete gene knockout. This functional screen identified over 90 protein kinases that are essential for cell viability and cell proliferation. Ten of these hits (CDK1, CDK2, CDK8, CDK10, CDK11A, CDK19, CDK19, CDC7, EPHA2 and WEE1) are well-known targets validated in the literature. Currently, we are in the process validating the novel hits through target gene sequencing, western blotting and target specific small molecule kinase inhibitors.
Screening Tests for Toxic Chemicals: An OverviewJoseph Holson
This document provides an overview of screening tests for toxic chemicals. It defines screens as simplified tests designed to identify agents requiring further evaluation or exclude them from further testing. Key purposes of screens include economic savings, increased speed and number of chemicals evaluated while decreasing animal use. Screens must be valid, sensitive, reproducible and practical. The document discusses criteria for validation and acceptance of new testing methods and provides examples of in vitro and in vivo screens used in toxicology. It also discusses how screens fit within the regulatory testing structure and notes some limitations of screens in fully characterizing toxicity.
This document provides guidelines for laboratory diagnosis of Chlamydia trachomatis infections in East European countries. It discusses sample collection and transport, diagnostic methods including culture, antigen detection, nucleic acid amplification tests, and considerations for implementing and interpreting these tests. Commercial nucleic acid amplification tests are highlighted but caution is given around using non-approved tests.
Dancey Clinical Trials Vancouver Dancey 20110302 Final.Ppt [Compatibility Mode]Warren Hamilton
High content clinical trials involve dense sample collection and complex analyses from small patient numbers. They are important for early drug development and evaluation, addressing biological questions about target and pathway inhibition. Successful high content trials require standardized assays and infrastructure across sites, as well as collaboration between multiple institutions. Challenges include developing new science and technologies, building collaborative partnerships, and establishing operational and informatics systems for specimen and data management.
A blood protein marker for the early detection of pre- eclampsia Priyesh Waghmare
The document describes a proposed diagnostic device for the early detection of pre-eclampsia. The device would use a one-step, 15 minute test to measure levels of three biomarkers (PlGF, sflt-1, sEng) in blood to screen pregnant women in their first trimester. Current diagnosis methods are time-consuming and have high rates of false positives. The proposed device aims to provide a simple, rapid, inexpensive and early screening with high sensitivity and specificity to address the market need for improved pre-eclampsia detection.
This study analyzed omics data from over 70 breast cancer cell lines to develop predictive signatures of drug response. Pretreatment measurements included mRNA expression, copy number, protein expression, gene mutations, and transcriptome and methylation assays. Machine learning algorithms were used to identify associations between biological responses to therapy and pretreatment signatures. The developed signatures could predict drug response probabilities and help inform precision treatment recommendations for breast cancer patients. However, cell lines do not capture the full tumor microenvironment impacting response.
PREDICTIVE AND DIAGNOSTIC BIOMARKERS FOR OVARIAN CANCERDr. Girija Wagh
OVARIAN CANCER HAS ELUDED SCREENING AND EARLY DETECTION . SEVERAL BIOMARKERS ARE PROPOSED AND HERE IS A AN UPDATED REVIEW OF WHAT EXISTS IN THE CURRENT CLIMATE FOR THE SAME Ovarian carcinomas relate to highest death rate in gynecologic malignancies as absence of symptoms shield the disease in the early stage. Current evidences have been devoted to discovering early effective screening mechanism prior to the onset of clinical symptoms.Serum biomarkers may aid in the diagnosis of Early ovarian cancer
Distinguish malignant from benign disease
Prevent unnecessary surgery
Improve rates of early detection. Prof Girija Wagh is the Head of the Department of OBG at Bharati University Medical College and Hospital and a well acknowledged teacher and a researcher.This overview will certainly help the learners to approach this condition with more promise
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
This document discusses biomarkers for assessing immune function throughout the drug development process. It describes how various techniques can be used to identify, validate, and qualify biomarkers. These include flow cytometry to analyze cell populations and activation markers, Luminex to measure cytokine levels, and gene expression profiling using NanoString. Whole blood stimulation assays are discussed as a way to assess target engagement and immune responses ex vivo. The importance of assay validation and understanding sources of variation are also covered. Biomarkers can provide insights into mechanisms of action, safety, and efficacy to support clinical development.
Tumour Markers are substances present in the tumour, produced by the tumour or by the host as a response to the presence of the tumour, providing information about biological characteristics of the tumour. these tumour markers may specific for the tissue but often get elevated in neoplastic as well non-neoplastic lesions, further Various analytical platforms available for serum tumour markers lack standardisation. These factors add to interpretative challenges in serum tumour markers
Susan Cho Hicks has over 20 years of experience in clinical laboratory operations and management, specializing in molecular diagnostics and next generation sequencing. She currently serves as the Associate Director of Laboratory Operations at Sequenom Laboratories, where she oversees daily operations, quality management, and expansion of the non-invasive prenatal testing laboratory. Prior to this, she held various clinical laboratory roles with increasing responsibility at other companies developing technologies in oncology and infectious disease testing.
This document summarizes a presentation on non-invasive prenatal testing (NIPT). The presentation describes the history and current techniques used for NIPT, including analyzing cell-free fetal DNA from maternal plasma using massively parallel sequencing. It reviews the performance of NIPT in detecting common trisomies like Trisomy 21, with detection rates over 99% and low false positive rates. The presentation discusses the potential for NIPT to be expanded to more conditions and become a primary screening for all pregnancies.
Lesi Prakanker - Dr. dr. Poedjo Hartono, SpOG(K)pogisurabaya
This document discusses various methods for early detection of cervical cancer, including the Pap smear test and its limitations. It describes the Pap smear as the gold standard screening method but notes it has false negative and positive rates of 42% and limitations with specimen collection and analysis. The document summarizes alternative screening methods like ThinPrep, HPV testing, visual inspection with acetic acid, and a computer-assisted screening method called PapNet. It also provides details on cervical cancer classifications systems like The Bethesda System and explains concepts like ASCUS, LGSIL, HGSIL, and adenocarcinoma.
This document discusses a presentation on microbiome identification and characterization technologies. It begins with an introduction to the human microbiome and catalogs our "second genome". It then discusses how technologies like 16S rRNA sequencing and metagenomics have unlocked the ability to study the microbiome. Population studies of microbiome composition and disease associations are also reviewed. The presentation goes on to provide examples of how to design assays to identify and profile relevant microbiome targets, and discusses solutions for identification and profiling in microbiome research.
Vaccine Cell Bank and Virus Seed CharacterizationMilliporeSigma
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
- new technologies for determining the identity of cell substrates and virus seed stocks
- detecting adventitious agent contamination
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
- new technologies for determining the identity of cell substrates and virus seed stocks
- detecting adventitious agent contamination
Illumina is a leader in genomics technologies that provide reliable answers to guide reproductive and genetic health choices. Their portfolio includes technologies for preimplantation genetic screening and diagnosis, non-invasive prenatal testing, cytogenetics, carrier screening, and identifying inherited conditions. These solutions deliver accurate information through next-generation sequencing and microarrays to empower informed choices and transform lives along the healthcare continuum.
Website pdspatklinsby ini dibuat untuk berbagi ilmu dan informasi patologi klinik, serta menerima kritik dan saran untuk perbaikan website yang belum sempurna.
[Ringkasan]
Dokumen tersebut membahas tentang mekanisme hemostasis sekunder melalui jalur ekstrinsik. Secara singkat, dokumen menjelaskan tiga komponen utama dalam mekanisme ini yaitu pembuluh darah, trombosit, dan sistem pembekuan darah. Ketiga komponen tersebut bekerja sama untuk mencegah dan menghentikan perdarahan melalui vasokonstriksi, aktivasi trombosit, dan pembentukan fibrin.
Teks ini memberikan panduan lengkap tentang prosedur pengambilan darah kapiler dari jari atau tumit untuk berbagai kelompok usia, mulai dari persiapan, pemilihan lokasi penusukan, teknik pengumpulan sampel darah, urutan pengumpulan, hingga komplikasi yang mungkin terjadi. Prosedur ini hanya memerlukan sedikit darah dan bermanfaat untuk neonatus, bayi, anak, maupun dewasa ketika venipuncture sul
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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1. LOGO
1
Journal Reading Divisi Imunologi
Diagnostic Markers for Early
Detection of Ovarium cancer
Irene Visintin, Ziding Feng, Gary L, David C.Wards et all
Clin Cancer Res 2008; 14(4): 1065-1072
Sri Widyaningsih, dr/ Endang Retnowati, dr, MS., SpPK (K)
Rabu, 14 Juli 2010 1
2. Pendahuluan
Cancer Ovarium
Penyebab kematian kanker yg menduduki urutan ke-5
pd wanita (USA)
-
Angka kematian yg tinggi disebabkan oleh tes skrining yg krg
adekuat pd stad. dini
Sensitivitasnya CA 125 pd stad.dini < 60%
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Tes dgn 4 biomarker memberikan sensitivitas 95%, spesifisitas 94%
2
3. Tujuan Penelitian
Mengevaluasi panel biomarker dan
penggunaan alternatif platform untuk
meningkatkan sensitivitas & spesifisitas
Deteksi dini Ca. ovarium
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3
4. Material dan Metode
Penelitian ini
- Prospective cohort study, Discovery to Cure, in
Dept. Obstetrics and Gynecologic,Yale
University
- Agustus 2002 - November 2006 :
- 156 sampel (36 stad I/II, 120 stad III/IV)
- wanita yg baru didiagnosis Ca ovarium
(25-88 th)
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4
5. - Diagnosis Ca ovarium ditentukan berdsrkan :
clinical, surgical, histologic, dan pathologic pd
Gynecologic Oncology Clinic at the Yale New
Haven Hospital
- Informed consent untuk semua partisipan
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5
6. Kriteria kontrol sehat :
Kriteria inklusi : - Umur ≥ 18 th
- wanita yg - Menjalani pemeriksaan
baru didiagnosis ginekologi teratur
Ca. ovarium -Tidak pernah
didiagnosis Ca
Kriteria eksklusi -Tdk ada riwayat klg
- Punya riwayat Ca. Ca. Ovarium &
ovarium bebas penyakit
- Didiagnosis Ca lain sedikitnya < 6 bln
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dlm 5 th terakhir setelah pangambilan
- Sedang menjalani sampel
kemoterapi -Merokok (-) & terapi
hormon (-)
6
8. Multiplex study design
535 sampel
Training set (294) Test set (224)
Kontrol (181) Sampel (113) Kontrol (181) Sampel (43)
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17 Benign
disease
8
9. Statistik
ROC Logistic regression model
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9
10. Hasil
Evaluasi ELISA dan multiplex platform
- membandingkan prolactin, leptin, OPN, IGF II
pd Elisa & multiplex sensitivitas (95%) dan
spesifisitas (94%) yg sama
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10
12. Hasil
Karakteristik six biomarker multiplex platform-
training set :
- Meningkatkan sensitivitas dan spesifisitas
multiplex assay + MIF & CA 125
- Pd training set MIF signifikan lbh tinggi pd
Ca. ovarium dari pada kontrol sehat
- Pd Ca. ovarium prolactin, OPN, CA 125
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meningkat, sdgkan leptin, IGF-II menurun
12
15. ROC setiap marker training set hasilnya
signifikan dpt membedakan Ca. ovarium dgn
kontrol sehat
Semua model pd training set akurasi klasifikasi
>98%
Misclassification model 0,8% - 2,1%
Misclassification CA 125 14%
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15
17.
Karakteristik six biomarker multiplex platform-
test set :
- AUC & ROC dari 4 model lebih baik daripada
CA 125
Final model six biomarker pd multiplex platform:
- Tdk ada perbedaan model I pd training set,
test set, atau kombinasi training dan test set
- Final model untuk kombinasi training & test set
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- 362 kontrol sehat 2 misclassified
156 Ca.ovarium 5 misclassified
17
23. Multiplex six markers sensitivitas-spesifisitas
lbh baik daripada 4-plex Elisa
Final model sensitivitas 95,3%
spesifisitas 99,4%
PPV = 99,3%
NPV = 99,2%
Perlu penelitian multicenter final model
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23
24. Diskusi
Pd penelitian ini six biomarker multiplex platform
dpt membedakan wanita sehat dan Ca. ovarium
dgn sensitivitas 95,3%, spesifisitas 99,4%
Lokasi Ca. msh di ovarium pd saat awal
diagnosis survival rate selama 10 th (± 90%)
Bila menggunakan salah satu marker
sensitivitas & spesifisitas rendah
Kombinasi marker sensitivitas & spesifisitas
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tinggi
24
25. Anderson, mengusulkan marker diagnosis
melalui tahapan :
- penemuan px, validasi, implementasi klinik
Multiplex platform memberikan keuntungan
untuk penerapan diagnosis
Panel protein dpt mendeteksi dini stad. awal
Ca. ovarium
Pd penelitian ini menggunakan different cohort
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training dan test set
25
26. Kesimpulan
Tes ini telah memenuhi tahapan yg telah
diusulkan sebelumnya, sehingga dpt membatasi
untuk skrining hasil positif palsu
Implementasi tes ini untuk deteksi dini
Ca. ovarium
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26
28. Reasoning that the protein profile in urine may be
less complex than that in blood, and that proteins in
urine may be more stable than those in blood, as well
as recognizing the convenience that a urinary test
would have when compared with a more invasive
blood test, Ye et al. (1) assessed the protein/peptide
profiles in the urine of women with ovarian cancer.
Proteomic-Based Discovery and Characterization of
Glycosylated Eosinophil-Derived Neurotoxin and
COOH-Terminal Osteopontin Fragments for Ovarian
Cancer in Urine
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28
29. The proteome is the entire set of proteins
expressed by a genome, cell, tissue or
organism.
More specifically, it is the set of expressed
proteins in a given type of cells or an
organism at a given time under defined
conditions
Advances in the fields of genomics and
proteomics are hoped to provide insights
into the molecular complexity of the
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disease process and thus enable the
development of tools to help in treatment
as well as in detection and prevention.
29
30. Leptin
is a 16 kDa protein hormone
plays a key role in regulating energy
intake and energy expenditure,
including appetite and metabolism
It is manufactured primarily in the
adipocytes of white adipose tissue,
and the level of circulating leptin is
directly proportional to the total
amount of fat in the body
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Leptin promotes angiogenesis by
increasing
vascular endothelial growth factor
(VEGF) levels 30
31. Prolactin
Prolactin (PRL) or Luteotropic
hormone (LTH) is a peptide hormone
primarily associated with lactation
Increased serum concentrations of
prolactin during pregnancy
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31
32. Prolactin receptors are present in the
mamillary glands, ovaries, pituitary
glands, heart, lung, thymus, spleen,
liver, pancreas, kidney, adrenal
gland, uterus, skeletal muscle, skin
and areas of the central nervous
system
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32
33. Osteopontin
Osteopontin (OPN), also known as
bone sialoprotein I (BSP-1), early T-
lymphocyte activation (ETA-1), and
secreted phosphoprotein 1
Osteopontin has been implicated as
an important factor in
bone remodeling
OPN mediates cell activation and
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cytokine production, as well as
promoting cell survival by regulating
apoptosis
33
34. OPN is an important anti-apoptotic
factor in many circumstances.
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34
35. Osteopontin is biosynthesized by a
variety of tissue types including
fibroblasts[9] preosteoblasts,
osteoblasts, osteocytes, odontoblasts
,
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35
36. Macrophage migration inhibitory
factor (MIF) is a protein which in
humans is encoded by the MIF gene
However, the biological mechanism
and significance of MIF remains
unknown.
Additionally, some evidence
suggests that MIF might be linked to
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a small positive correlation between
MIF production and metastatic
potential in speculative models of
cancer
36
37. MIF plays a role in the regulation of
macrophage function in host defense
through the suppression of anti-
inflammatory effects of
glucocorticoids
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37
38. IGF
The insulin-like growth factors
(IGFs) are polypeptides with high
sequence similarity to insulin
IGF-1 is important for both the
regulation of normal physiology, as
well as a number of pathological
states, including cancer
The IGF axis has been shown to play
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roles in the promotion of
cell proliferation and the inhibition of
cell death (apoptosis)
38
39. Almost every cell in the human body
is affected by IGF-1, especially cells
in muscle, cartilage, bone, liver,
kidney, nerves, skin, and lungs.[
citation needed]
In addition to the insulin-
like effects, IGF-1 can also regulate
cell growth and development,
especially in nerve cells, as well as
cellular DNA synthesis.
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39
40. CA 125
CA-125 (cancer antigen 125 or
carbohydrate antigen 125) also
known as mucin 16 or MUC16 is a
protein that in humans is encoded by
the MUC16 gene.[1][2]
CA-125 has found application as a
tumor marker or biomarker that may
be elevated in the blood of some
patients with specific types of
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cancers.[4]
40
41. CA-125 is clinically approved for
following the response to treatment
and predicting prognosis after
treatment. It is especially useful for
detecting the recurrence of ovarian
cancer
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41
43. Phosphatidylinositol 3-kinases (PI 3-
kinases or PI3Ks) are a family of
enzymes involved in cellular
functions such as cell growth,
proliferation, differentiation, motility,
survival and intracellular trafficking,
which in turn are involved in cancer.
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43
44. High risk Ca ov
Ovarian cancer is rare in women younger than
40. Most ovarian cancers develop after
menopause. Half of all ovarian cancers are
found in women over the age of 63.
it does seem that obese women (those with a
body mass index of at least 30) do have a
higher risk of developing ovarian cancer
A woman who has had children has a lower
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risk of ovarian cancer than women who have no
children
44
45. PI3K
Phosphatidylinositol 3-kinases (PI 3-
kinases or PI3Ks) are a family of
enzymes involved in cellular
functions such as cell growth,
proliferation, differentiation, motility,
survival and intracellular trafficking,
which in turn are involved in cancer.
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45
46. PI3Ks are a family of related
intracellular signal transducer
enzymes capable of phosphorylating
the 3 position hydroxyl group of the
inositol ring of phosphatidylinositol
(PtdIns).[2] They are also known as
phosphatidylinositol-3-kinases. The
pathway, with oncogene PIK3CA and
tumor suppressor PTEN (gene) is
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implicated in insensitivity of cancer
tumors to insulin and IGF1, in
calorie restriction.[3][4]
46
48. High risk
Fertility drugs seem to increase the
risk of the type of ovarian tumors
Androgens are male hormones
Estrogen therapy and hormone
therapy
Family history of ovarian cancer,
breast cancer, or colorectal cancer
Talcum powder
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48
49. Ovarian cancer staging is by the FIGO
Stage I - limited to one or both ovaries
Stage II - pelvic extension or implants
Stage III - microscopic peritoneal implants
outside of the pelvis; or limited to the pelvis with
extension to the small bowel or omentum
Stage IV - distant metastases to the liver or
outside the peritoneal cavity
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49
50. International Federation of Gynecologists & Obstetrician
FIGO Staging, ovarian carcinoma
I Malignancy of one (Ia) or both (Ib)
ovaries, without ascites
II Malignancy of one (IIa) or both (IIb)
ovaries, with pelvic extension and ascites
III Malignancy involves one/both ovaries,
intraperitoneal metastases outside pelvis
IV Involvement of one/both ovaries with
metastases and histologically confirmed
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extension to pleural cavity or liver
50
52. Human leptin is a protein of 167
amino acids.
It is manufactured primarily in the
adipocytes of white adipose tissue
and the level of circulating leptin is
directly proportional to the total
amount of fat in the body
Leptin acts on receptors in the
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hypothalamus of the brain where it
inhibits appetite
52
53. Sedangkan faktor resiko tejadinya
kanker ovarium adalah:
# Obat kesuburan
# Pernah menderita kanker payudara
# Riwayat keluarga yang menderita
kanker payudara dan/atau kanker
ovarium
# Riwayat keluarga yang menderita
kanker kolon, paru-paru, prostat dan
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rahim
53
54. Leptin activates the PI3-
Kinase/AKTsignaling pathway
pathways have been implicated in playing
crucial roles in regulating cell growth, cell
proliferation prevention of apoptosis, which
altogether attribute tumorigenesis [15].
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54
55. In conclusion, the present study has
demonstrated that acquired
expression of OPN may enable
ovarian cancer cells to thrive under
stress conditions by up-regulating
the cellular level of HIF-1α protein
and activating the PI3-K/Akt survival
pathway.
These findings indicate that OPN is
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closely associated with the
progression of ovarian cancer, and
OPN may be considered as a
55
56. useful molecular target for the
therapeutic development of ovarian
cancer.
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56
57. The mechanisms underlying the
antiapoptotic effect of PRL on ovarian
carcinoma cells have not yet been
clarified.
Ruffion et al.21 suggested that PRL
inhibits apoptosis through
stimulation of the
phosphatidylinositol-3OH kinase
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(PI3K)-Akt pathway
57
58. Cohort studies: (1) fokusnya adalah
spesifik populasi; (2) dilakukan
secara berkala; (3)
populasi keadaan awal dan diikuti.
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58
59. The immune-complex/
microsphere is then excited
by the ****** laser. The bead
specific emmission is
quantified by the luminex
and the bead identified.
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59
61. Gen p53 secara normal menyandi
protein dengan berat molekul 53 kDa
yang terlibat dalam kontrol
pertumbuhan sel. Terjadinya mutasi
pada gen ini dapat menyebabkan
pertumbuhan sel menjadi tidak
terkontrol (Gondhowiarjo, 2004)
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