This document provides information about the services offered by a central laboratory for clinical trials and drug discovery. The laboratory provides quality central laboratory services for clinical trials, maintains confidentiality, and meets regulatory standards. It has offered services to leading pharmaceutical companies for preclinical and clinical trials. The services described include in vitro and in vivo ADME studies, cell-based assays, in vivo pharmacology studies, toxicology studies, analytical chemistry services, and more.
Identify Compounds that Rescue Disease Relevant Mutant Membrane ProteinsDiscoverX Corporation
Learn about diseases caused by protein misfolding and how you can screen for compounds, known as pharmacochaperones, that rescue misfolded proteins and could be used as therapeutics.
Breaking the Status Quo: Using Mass Spectrometry to detect Host Cell ProteinsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Tbcd
Measurement of host cell proteins is vital to ensuring a biotherapy's purity and a patient's safety. Biotherapies treat diseases with products produced by living organisms, as a result, host cell components must be characterized and controlled. We'll review new methods within product characterization for detection.
Trace amounts of host cell proteins can be present after the production and purification of any biopharmaceutical. Detection of these species requires highly specific techniques to accurately quantify even low levels of contamination. Host cell protein impurities, present at PPM-levels in biotherapies, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. Their complex and diverse nature makes them challenging to detect or monitor. With acceptance criteria for host residual DNA usually set at a very low level (often =1.0 pg of DNA per mg of drug substance), effective removal techniques and sensitive methods of detection are critical.
Antibody-based techniques, like the enzyme-linked immunosorbent assay (ELISA), have been used to assess the HCP load of biotherapeutics before and after process changes. However, these techniques do not necessarily detect qualitative changes in the HCP population. In this webinar, we will discuss how mass spectrometry (MS)-based approaches coupled with ELISA methods help detect qualitative and quantitative differences in HCP populations.
In this webinar, you will learn:
• Comprehensive HCP ID and semi-quantitation
• HC agnostic process
• Creation of process specific database
• Differential clearance of specific HCPs throughout purification steps
• Monitoring of problematic species e.g. immunogenic (PLBL2), lipases and proteases
• Explanation about why 90% of BLAs filed included this HCP MS data
Biofluid miRNA profiling: from sample to biomarker: miRNA and its Role in Hum...QIAGEN
Circulating miRNAs have great potential as biomarkers due to their aberrant expression in cancer and other diseases. However, miRNAs from body fluids are hard to obtain in amounts sufficient for detailed miRNome profiling. This slideshow describes an integrated, PCR-based system that reduces the amount of sample required for full miRNome profiling by several orders of magnitude and provides unparalleled reproducibility and precision. Detailed protocols are highlighted regarding RNA isolation, real-time quantification and data analysis for the assessment of serum, plasma, urine and cerebrospinal fluid samples. This system enables accurate miRNA analysis on the smallest of samples and opens up new possibilities for biomarker development.
When your focus is small molecules, biomarkers, or protein biotherapeutics,
QPS’ LC-MS/MS laboratories provide a full range of
bioanalytical solutions to support drug development
from discovery through clinical development.
Identify Compounds that Rescue Disease Relevant Mutant Membrane ProteinsDiscoverX Corporation
Learn about diseases caused by protein misfolding and how you can screen for compounds, known as pharmacochaperones, that rescue misfolded proteins and could be used as therapeutics.
Breaking the Status Quo: Using Mass Spectrometry to detect Host Cell ProteinsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Tbcd
Measurement of host cell proteins is vital to ensuring a biotherapy's purity and a patient's safety. Biotherapies treat diseases with products produced by living organisms, as a result, host cell components must be characterized and controlled. We'll review new methods within product characterization for detection.
Trace amounts of host cell proteins can be present after the production and purification of any biopharmaceutical. Detection of these species requires highly specific techniques to accurately quantify even low levels of contamination. Host cell protein impurities, present at PPM-levels in biotherapies, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. Their complex and diverse nature makes them challenging to detect or monitor. With acceptance criteria for host residual DNA usually set at a very low level (often =1.0 pg of DNA per mg of drug substance), effective removal techniques and sensitive methods of detection are critical.
Antibody-based techniques, like the enzyme-linked immunosorbent assay (ELISA), have been used to assess the HCP load of biotherapeutics before and after process changes. However, these techniques do not necessarily detect qualitative changes in the HCP population. In this webinar, we will discuss how mass spectrometry (MS)-based approaches coupled with ELISA methods help detect qualitative and quantitative differences in HCP populations.
In this webinar, you will learn:
• Comprehensive HCP ID and semi-quantitation
• HC agnostic process
• Creation of process specific database
• Differential clearance of specific HCPs throughout purification steps
• Monitoring of problematic species e.g. immunogenic (PLBL2), lipases and proteases
• Explanation about why 90% of BLAs filed included this HCP MS data
Biofluid miRNA profiling: from sample to biomarker: miRNA and its Role in Hum...QIAGEN
Circulating miRNAs have great potential as biomarkers due to their aberrant expression in cancer and other diseases. However, miRNAs from body fluids are hard to obtain in amounts sufficient for detailed miRNome profiling. This slideshow describes an integrated, PCR-based system that reduces the amount of sample required for full miRNome profiling by several orders of magnitude and provides unparalleled reproducibility and precision. Detailed protocols are highlighted regarding RNA isolation, real-time quantification and data analysis for the assessment of serum, plasma, urine and cerebrospinal fluid samples. This system enables accurate miRNA analysis on the smallest of samples and opens up new possibilities for biomarker development.
When your focus is small molecules, biomarkers, or protein biotherapeutics,
QPS’ LC-MS/MS laboratories provide a full range of
bioanalytical solutions to support drug development
from discovery through clinical development.
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.
Oncodesign aacr 2018 development of a high throughput in vitro screening pl...Florence Fombertasse
Immunological cell death (ICD) is a form of cancer cell death induced by radiotherapy, photodynamic therapy and a few chemotherapeutic agents such as Doxorubicin, Mitoxantrone, and Oxaliplatin. Unlike apoptosis or necrosis, ICD can induce an effective immune response directed against the tumor whereby both dendritic cells and T lymphocytes are mediators of this response. Dying cancer cells recruit and activate immune cells by releasing damage-associated molecular patterns (DAMPS) that help and promote the immune response to antigenic tumor neo-epitopes. Three key DAMPS are associated with the ICD process: calreticulin exposition on the cell surface, ATP secretion and high-mobility group box 1 (HMGB1) release. In order to identify new therapeutic agents that promote ICD in malignant cells, we developed a screening strategy facilitated by an automated in vitro platform with four assays on three different tumor cell lines (human osteosarcoma U-2 OS, human breast MDA-MB-231 and murine liver Hepa 1-6). ICD inducers Doxorubicin and Mitoxantrone used as positive controls increased ATP secretion by 2 to 10-fold at a non-cytotoxic dose after 72 hours incubation on the three cell lines. Both compounds also increased calreticulin exposition by 2 to 4-fold (determined by immunofluorescence using the Operetta High-Content Imaging System) and HMGB1 release by two-fold on the three cell lines. Here we will present recent data from the screening of Oncodesign’s Nanocyclix® library using this platform to identify novel ICD inducers.
There are tens of thousands of man-made chemicals to which humans are exposed, but only a fraction of these have the extensive in vivo toxicity data used in most traditional risk assessments. This lack of data, coupled with concerns about testing costs and animal use, are driving the development of new methods for assessing the risk of toxicity. These methods include the use of in vitro high-throughput screening assays and computational models.
This presentation by Dr. Richard Judson reviewed a variety of high-throughput, non-animal methods being used at the U.S. EPA to screen chemicals for a variety of toxicity endpoints, including methods for providing mechanistic data like the Adverse Outcome Pathway.
EPA is committed to sound science, and we are proud to have some of the world's best scientists, many of whom are internationally recognized as leaders in their fields. Not only are EPA's scientific experts vital to achieving our mission, but they are dedicated to sharing knowledge and contributing to their the scientific communities, which helps further advance the science that protects human health and the environment. Part of this includes giving presentations to other members of the scientific community. We have posted some of these presentations here so that more people have access.
Learn more about Dr. Richard Judson - https://www.epa.gov/sciencematters/meet-epa-researcher-richard-judson
Learn more about EPA's Chemical Safety Research - https://www.epa.gov/chemical-research
There are tens of thousands of man-made chemicals to which humans are exposed, but only a fraction of these have the extensive in vivo toxicity data used in most traditional risk assessments. This lack of data, coupled with concerns about testing costs, are driving the development of new methods for assessing the risk of toxicity.
This presentation by Dr. Richard Judson reviewed methods being used at the U.S. EPA to use zebrafish as an in vivo model of vertebrate developmental toxicity and build in vitro to in vivo models using human assays.
EPA is committed to sound science, and we are proud to have some of the world's best scientists, many of whom are internationally recognized as leaders in their fields. Not only are EPA's scientific experts vital to achieving our mission, but they are dedicated to sharing knowledge and contributing to their the scientific communities, which helps further advance the science that protects human health and the environment. Part of this includes giving presentations to other members of the scientific community. We have posted some of these presentations here so that more people have access.
Learn more about Dr. Richard Judson - https://www.epa.gov/sciencematters/meet-epa-researcher-richard-judson
Learn more about EPA's Chemical Safety Research - https://www.epa.gov/chemical-research
Answer four fundamental questions on how to develop the most innovative cancer immunotherapy treatments, starting with screening for lead molecules and ending with evaluation of combination therapies.
There are tens of thousands of man-made chemicals to which humans are exposed, but only a fraction of these have the extensive in vivo toxicity data used in most traditional risk assessments. This lack of data, coupled with concerns about testing costs and animal use, are driving the development of new methods for assessing the risk of toxicity. These methods all start with the use of in vitro assays, e.g. for activity against the estrogen and androgen receptors (ER and AR) and targets in the steroidogenesis and thyroid signaling pathways. Because all individual assays are subject to a variety of noise processes and technology-specific assay artifacts, we have developed methods to create consensus predictions from multiple assays against the same target. The goal of these models is to both robustly predict in vivo activity, and also to provide quantitative estimates of uncertainty. This presentation by Dr. Richard Judson described these models and how they are validated against both in vitro and in vivo reference chemicals.
EPA is committed to sound science, and we are proud to have some of the world's best scientists, many of whom are internationally recognized as leaders in their fields. Not only are EPA's scientific experts vital to achieving our mission, but they are dedicated to sharing knowledge and contributing to their the scientific communities, which helps further advance the science that protects human health and the environment. Part of this includes giving presentations to other members of the scientific community. We have posted some of these presentations here so that more people have access.
Learn more about Dr. Richard Judson - https://www.epa.gov/sciencematters/meet-epa-researcher-richard-judson
Learn more about EPA's Chemical Safety Research - https://www.epa.gov/chemical-research
The Comprehensive Guide to Genotoxicity AssessmentMilliporeSigma
Discover solutions for all phases of product development for genetox assessment from in silico analysis, screening, mode of action assessment, or GLP regulatory required assays. Our BioReliance® Genetic Toxicology Services director will share specifics and rationale for each assay category.
In this webinar you will:
- Learn the required regulatory assays
- Understand why each assay is used and how to employ different assay designs
- Learn different assays and techniques to screen potential compounds and understand mechanism and mode of action
Presented by Rohan Kulkarni, Ph.D., ERT, Director Toxicology, Study Management on February 9, 2017
Liquid biopsy: Overcome Challenges of Circulating DNA with Automated and Stan...QIAGEN
Circulating cell-free DNA (ccfDNA) originating from malignant tumors, a developing fetus and also from inflammatory tissues, is present in the cell-free nucleic acids in plasma, serum and other body fluids and is considered a “liquid biopsy”. Access to ccfDNA for analysis allows for specific detection of certain disease states based on a simple blood sample. Circulating cell-free DNA shows distinctive properties – it is present mostly as shorter fragments of less than 500 bp and the concentration of ccfDNA in a plasma or serum sample is low (approximately 1–100 ng/ml) compared to cellular materials and varies considerably between different individuals.
Because of their fragmented nature and low concentration, ccfDNA presents a particular challenge for efficient extraction / purification and quantification, such as by qPCR. We present data on solutions for the following critical problems concerning the purification of ccfDNA for research and molecular diagnostic applications:
• Pre-analytical workflow (blood processing) for analyzing ccfDNA
• Optimization of ccfDNA extraction from plasma samples: low target concentrations require efficient ccfDNA enrichment from larger sample volumes
• Novel automated extraction of ccfDNA using the QIAsymphony SP instrument for liquid biopsy diagnostic applications.
Automated Nucleic Acid Purification from Diverse Sample types using dedicated...QIAGEN
This webinar will focus on the automation of QIAGEN’s new line of DNA and RNA sample prep kits for the microbiome. We will show how automation on the QIAcube enables efficient and reliable use of these samples for sensitive downstream applications such as qPCR and NGS. In addition, you will learn how to successfully use the CLC Microbial Genomics Module for metagenome sequencing and identification of microbial composition and diversity.
Chromatrap® is able to reduce the time spent in the laboratory by minimising the need for manual handling. By reducing the time spent using a pipette and with no incubation required, it means that results are achieved faster.
A Turn-Key Flow-Through-Mode Purification Process to improve Quality and Safe...Merck Life Sciences
In this webinar, you will learn:
Intensified plasma Immunoglobulin purifications
Scalable process development with latest technologies
Improved safety and quality of plasma IgG meeting required quality attributes
Detailed description:
Plasma-derived immunoglobulins (IgG) are essential medicines that are in worldwide shortage. How to develop optimized processing steps for robust and efficient manufacturing has been a constant goal, to make the most out of the precious plasma raw material.
In this study, we present a worse-case equivalent of plasma intermediate, explore various process steps along the fractionation flow, including flow-through-mode chromatography, affinity chromatography, virus inactivation steps and removal of solvent/detergent, single-pass TFF (SPTFF), clarification, and aseptic filtration, to establish a robust, easy-to-operate, readily scalable plasma IgG process with over 99% purity, depletion of IgA, isoagglutinin, and thrombogenic markers, meeting the commonly required 20% concentration for subcutaneous IgG infusion. Such solutions would be appropriate for various IgG intermediates which help to improve the global supply of immunoglobulins.
Evaluation of ctDNA extraction methods and amplifiable copy number yield usin...Thermo Fisher Scientific
The use of cell-free circulating tumor DNA (ctDNA) for non-invasive cancer testing has the potential to revolutionize the field. However, emergence of an increasing number of extraction methods and detection assays is rendering laboratory workflow development much more complex and cumbersome. The use of standardized, well characterized ctDNA control materials in human plasma could facilitate the evaluation of extraction efficiency and assay performance across platforms. In this study, we use a full process ctDNA quality control material in true human plasma to demonstrate the variability of extraction yield between different ctDNA extraction kits. We also examine the correlation between the amplifiable
copy number and DNA concentration post-extraction.
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.
Oncodesign aacr 2018 development of a high throughput in vitro screening pl...Florence Fombertasse
Immunological cell death (ICD) is a form of cancer cell death induced by radiotherapy, photodynamic therapy and a few chemotherapeutic agents such as Doxorubicin, Mitoxantrone, and Oxaliplatin. Unlike apoptosis or necrosis, ICD can induce an effective immune response directed against the tumor whereby both dendritic cells and T lymphocytes are mediators of this response. Dying cancer cells recruit and activate immune cells by releasing damage-associated molecular patterns (DAMPS) that help and promote the immune response to antigenic tumor neo-epitopes. Three key DAMPS are associated with the ICD process: calreticulin exposition on the cell surface, ATP secretion and high-mobility group box 1 (HMGB1) release. In order to identify new therapeutic agents that promote ICD in malignant cells, we developed a screening strategy facilitated by an automated in vitro platform with four assays on three different tumor cell lines (human osteosarcoma U-2 OS, human breast MDA-MB-231 and murine liver Hepa 1-6). ICD inducers Doxorubicin and Mitoxantrone used as positive controls increased ATP secretion by 2 to 10-fold at a non-cytotoxic dose after 72 hours incubation on the three cell lines. Both compounds also increased calreticulin exposition by 2 to 4-fold (determined by immunofluorescence using the Operetta High-Content Imaging System) and HMGB1 release by two-fold on the three cell lines. Here we will present recent data from the screening of Oncodesign’s Nanocyclix® library using this platform to identify novel ICD inducers.
There are tens of thousands of man-made chemicals to which humans are exposed, but only a fraction of these have the extensive in vivo toxicity data used in most traditional risk assessments. This lack of data, coupled with concerns about testing costs and animal use, are driving the development of new methods for assessing the risk of toxicity. These methods include the use of in vitro high-throughput screening assays and computational models.
This presentation by Dr. Richard Judson reviewed a variety of high-throughput, non-animal methods being used at the U.S. EPA to screen chemicals for a variety of toxicity endpoints, including methods for providing mechanistic data like the Adverse Outcome Pathway.
EPA is committed to sound science, and we are proud to have some of the world's best scientists, many of whom are internationally recognized as leaders in their fields. Not only are EPA's scientific experts vital to achieving our mission, but they are dedicated to sharing knowledge and contributing to their the scientific communities, which helps further advance the science that protects human health and the environment. Part of this includes giving presentations to other members of the scientific community. We have posted some of these presentations here so that more people have access.
Learn more about Dr. Richard Judson - https://www.epa.gov/sciencematters/meet-epa-researcher-richard-judson
Learn more about EPA's Chemical Safety Research - https://www.epa.gov/chemical-research
There are tens of thousands of man-made chemicals to which humans are exposed, but only a fraction of these have the extensive in vivo toxicity data used in most traditional risk assessments. This lack of data, coupled with concerns about testing costs, are driving the development of new methods for assessing the risk of toxicity.
This presentation by Dr. Richard Judson reviewed methods being used at the U.S. EPA to use zebrafish as an in vivo model of vertebrate developmental toxicity and build in vitro to in vivo models using human assays.
EPA is committed to sound science, and we are proud to have some of the world's best scientists, many of whom are internationally recognized as leaders in their fields. Not only are EPA's scientific experts vital to achieving our mission, but they are dedicated to sharing knowledge and contributing to their the scientific communities, which helps further advance the science that protects human health and the environment. Part of this includes giving presentations to other members of the scientific community. We have posted some of these presentations here so that more people have access.
Learn more about Dr. Richard Judson - https://www.epa.gov/sciencematters/meet-epa-researcher-richard-judson
Learn more about EPA's Chemical Safety Research - https://www.epa.gov/chemical-research
Answer four fundamental questions on how to develop the most innovative cancer immunotherapy treatments, starting with screening for lead molecules and ending with evaluation of combination therapies.
There are tens of thousands of man-made chemicals to which humans are exposed, but only a fraction of these have the extensive in vivo toxicity data used in most traditional risk assessments. This lack of data, coupled with concerns about testing costs and animal use, are driving the development of new methods for assessing the risk of toxicity. These methods all start with the use of in vitro assays, e.g. for activity against the estrogen and androgen receptors (ER and AR) and targets in the steroidogenesis and thyroid signaling pathways. Because all individual assays are subject to a variety of noise processes and technology-specific assay artifacts, we have developed methods to create consensus predictions from multiple assays against the same target. The goal of these models is to both robustly predict in vivo activity, and also to provide quantitative estimates of uncertainty. This presentation by Dr. Richard Judson described these models and how they are validated against both in vitro and in vivo reference chemicals.
EPA is committed to sound science, and we are proud to have some of the world's best scientists, many of whom are internationally recognized as leaders in their fields. Not only are EPA's scientific experts vital to achieving our mission, but they are dedicated to sharing knowledge and contributing to their the scientific communities, which helps further advance the science that protects human health and the environment. Part of this includes giving presentations to other members of the scientific community. We have posted some of these presentations here so that more people have access.
Learn more about Dr. Richard Judson - https://www.epa.gov/sciencematters/meet-epa-researcher-richard-judson
Learn more about EPA's Chemical Safety Research - https://www.epa.gov/chemical-research
The Comprehensive Guide to Genotoxicity AssessmentMilliporeSigma
Discover solutions for all phases of product development for genetox assessment from in silico analysis, screening, mode of action assessment, or GLP regulatory required assays. Our BioReliance® Genetic Toxicology Services director will share specifics and rationale for each assay category.
In this webinar you will:
- Learn the required regulatory assays
- Understand why each assay is used and how to employ different assay designs
- Learn different assays and techniques to screen potential compounds and understand mechanism and mode of action
Presented by Rohan Kulkarni, Ph.D., ERT, Director Toxicology, Study Management on February 9, 2017
Liquid biopsy: Overcome Challenges of Circulating DNA with Automated and Stan...QIAGEN
Circulating cell-free DNA (ccfDNA) originating from malignant tumors, a developing fetus and also from inflammatory tissues, is present in the cell-free nucleic acids in plasma, serum and other body fluids and is considered a “liquid biopsy”. Access to ccfDNA for analysis allows for specific detection of certain disease states based on a simple blood sample. Circulating cell-free DNA shows distinctive properties – it is present mostly as shorter fragments of less than 500 bp and the concentration of ccfDNA in a plasma or serum sample is low (approximately 1–100 ng/ml) compared to cellular materials and varies considerably between different individuals.
Because of their fragmented nature and low concentration, ccfDNA presents a particular challenge for efficient extraction / purification and quantification, such as by qPCR. We present data on solutions for the following critical problems concerning the purification of ccfDNA for research and molecular diagnostic applications:
• Pre-analytical workflow (blood processing) for analyzing ccfDNA
• Optimization of ccfDNA extraction from plasma samples: low target concentrations require efficient ccfDNA enrichment from larger sample volumes
• Novel automated extraction of ccfDNA using the QIAsymphony SP instrument for liquid biopsy diagnostic applications.
Automated Nucleic Acid Purification from Diverse Sample types using dedicated...QIAGEN
This webinar will focus on the automation of QIAGEN’s new line of DNA and RNA sample prep kits for the microbiome. We will show how automation on the QIAcube enables efficient and reliable use of these samples for sensitive downstream applications such as qPCR and NGS. In addition, you will learn how to successfully use the CLC Microbial Genomics Module for metagenome sequencing and identification of microbial composition and diversity.
Chromatrap® is able to reduce the time spent in the laboratory by minimising the need for manual handling. By reducing the time spent using a pipette and with no incubation required, it means that results are achieved faster.
A Turn-Key Flow-Through-Mode Purification Process to improve Quality and Safe...Merck Life Sciences
In this webinar, you will learn:
Intensified plasma Immunoglobulin purifications
Scalable process development with latest technologies
Improved safety and quality of plasma IgG meeting required quality attributes
Detailed description:
Plasma-derived immunoglobulins (IgG) are essential medicines that are in worldwide shortage. How to develop optimized processing steps for robust and efficient manufacturing has been a constant goal, to make the most out of the precious plasma raw material.
In this study, we present a worse-case equivalent of plasma intermediate, explore various process steps along the fractionation flow, including flow-through-mode chromatography, affinity chromatography, virus inactivation steps and removal of solvent/detergent, single-pass TFF (SPTFF), clarification, and aseptic filtration, to establish a robust, easy-to-operate, readily scalable plasma IgG process with over 99% purity, depletion of IgA, isoagglutinin, and thrombogenic markers, meeting the commonly required 20% concentration for subcutaneous IgG infusion. Such solutions would be appropriate for various IgG intermediates which help to improve the global supply of immunoglobulins.
Evaluation of ctDNA extraction methods and amplifiable copy number yield usin...Thermo Fisher Scientific
The use of cell-free circulating tumor DNA (ctDNA) for non-invasive cancer testing has the potential to revolutionize the field. However, emergence of an increasing number of extraction methods and detection assays is rendering laboratory workflow development much more complex and cumbersome. The use of standardized, well characterized ctDNA control materials in human plasma could facilitate the evaluation of extraction efficiency and assay performance across platforms. In this study, we use a full process ctDNA quality control material in true human plasma to demonstrate the variability of extraction yield between different ctDNA extraction kits. We also examine the correlation between the amplifiable
copy number and DNA concentration post-extraction.
BioMAP® Systems for Investigative Toxicology & Safety Assessment. Presentation for the California Environmental Protection Agency’s 21st Century Toxicology Seminar Series, October 29, 2014, Sacramento, CA. Ellen Berg
Los días 11 y 12 de diciembre de 2014, la Fundación Ramón Areces celebró el Simposio Internacional 'Neuropatías periféricas hereditarias. Desde la biología a la terapéutica' en colaboración con CIBERER-ISCIII y el Centro de Investigación Príncipe Felipe. El tipo más común de estas patologías es la enfermedad de Charcot-Marie-Tooth, un trastorno neuromuscular hereditario con una prevalencia estimada de 17-40 afectados por 100.000 habitantes. Durante estos dos días, investigadores mostraron sus avances en la mejora del diagnóstico y el tratamiento y, por ende, de la aproximación clínica y la calidad de vida de las personas afectadas por estas patologías.
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.
Discover solutions for all phases of product development for genetox assessment from in silico analysis, screening, mode of action assessment, or GLP regulatory required assays. Our BioReliance® Genetic Toxicology Services director will share specifics and rationale for each assay category.
In this webinar you will:
- Learn the required regulatory assays
- Understand why each assay is used and how to employ different assay designs
- Learn different assays and techniques to screen potential compounds and understand mechanism and mode of action
Presented by Rohan Kulkarni, Ph.D., ERT, Director Toxicology, Study Management on February 9, 2017
Analytical Validation of the Oncomine™ Comprehensive Assay v3 with FFPE and C...Thermo Fisher Scientific
Presented here is an analytical validation of OCAv3 at the Life Technologies Clinical Services Laboratory (LTCSL), a CAP-accredited and CLIA-certified clinical laboratory. Analytical validations provide evidence of consistently accurate and relevant sequencing results.
services to pharmaceutical companies, biotech and CROs, for human health and animal health, providing consulting, training, validation services, software development, in data management or phamacovigilance.
Tumor Assessment CRF
Data Management
and Drug Safety
services to pharmaceutical companies, biotech and CROs, for human health and animal health, providing consulting, training, validation services, software development, in data management or phamacovigilance.
Implementation of CDISC standards
Statistic analysis or data reports to be used in pharamcovigilance or signal detection
1. Chromosoft drug discovery NETWORK Regulatory management Services TOOLS 9952968059
We are committed to provide quality central laboratory services for clinical trials, understanding fully that the reliability of clinical laboratory data is crucial
for the success of each trial. We maintain the integrity and confidentiality of your research which is critical to the well being of each study subject and
overall success of the trial. The lab provides services that meet the required regulatory standards of the pharmaceutical industry.
In last FEW years we have offered our services as central laboratory for Preclinical,clinical trials to most of the leading national and international
pharmaceutical companies.
ADME (Absorption, Distribution, Metabolism, Excretion)
In vitro ADME studies help in optimization of pharma cokinetic characteristics of a drug candidate , identify the
metabolic pathways and provide valuable inputs for the design of in vivo studies. We offer both standardized as
well as customized assays.
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In vivo
Permeability (Caco2, MDCK and PAMPA)
Aqueous Solubility
Metabolic stability and biotransformation
Test systems (microsomes, hepatocytes, S9, recombinant enzymes)
Species (rodent, guinea pig, rabbit, canine,non-human primate, human)
Protein binding (Equilibrium Dialysis and Ultrafiltration)
CYP Induction
CYP Isozyme Mapping
CYP Inhibition
Metabolite ID and profiling
Mass balance and drug disposition
In vivo pharmacokinetic (PK) services involve doseranging and bioavailability studies of drug candidates and
their metabolites. Compounds are administered at fixed concentrations and biological samples (blood/serum) are
collected at fixed time points for UPLC and LC/MS/MS analysis.
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Mouse and rat pharmacokinetics
Bioequivalence
Tissue distribution
Molecular biology
Gene regulation
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RNA interference, siRNA, shRNA,
Micro RNA, miR RNA interference
Immunoassays
Gene expression analysis
Nucleic acid analysis
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DNA isolation and purification
RNA isolation and purification
cDNA synthesis
DNA sequencing
Cloning
PCR analysis
Quantitative real time PCR
2. Chromosoft drug discovery NETWORK Regulatory management Services TOOLS 9952968059
Proteomics
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Protein expression profiling (Array based)
SDS-PAGE
Immunoblotting
Clinical & diagnostic applications
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Cell cycle analysis
Cell proliferation assays
Apoptosis assays
Mitochondrial membrane potential analysis
Oxidative burst assay
Reactive oxygen species analysis
Autophagy assay
Immunofluorescence (confocal microscopy)
Cell isolation and expansion
Cell immortalization
Cell sorting services
Hematopoietic stem cell analysis
Immunophenotyping
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Acute myeloid leukemia characterization
Acute lymphobastic leukemia characterization
T-ALL diagnosis
B-ALL diagnosis
Chronic lymphoproliferative disorder diagnosis
Hairy cell leukemia
Multiple myeloma
Invitro Pharmacology
Molecular Biology
DNA sequencing to DNA services have become routine tools in drug discovery research, preclinical and clinical
development. Both basic and advanced DNA technologies are used on a daily basis in most research laboratories.
CRC Drug discovery Network offers you a wide range of services has follows,
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DNA Library Creation
DNA Library Screening
Cloning of target genes into vectors
Gene Amplification and optimization (PCR)
Site directed mutagenesis
DNA Sequencing
Microbial identification
Fragment analysis
DNA Sub-cloning
DNA and RNA Isolation
Northern blotting
Gene expression analysis by Real Time PCR
Cell based assays
3. Chromosoft drug discovery NETWORK Regulatory management Services TOOLS 9952968059
Cell-based assays are a vital early step in the testing of your compounds and drug candidates for activity.
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Proprietary Cell-Based Assays
High-throughput Fluorescence based assays
Primary Cells and Proprietary Cell based assays
Our Assays include:
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Angiogenesis
Apoptosis
Cell Migration
Cell Cycle analysis (Flow cytometer)
Cell Viability (MTT, SRB, CyQuant, 3H)
Inflammation and Cytokines assays
Reporter Gene assays (Luciferase)
Glucose Uptake
In vivo Pharmacology
We offer wide range of preclinical in vivo pharmacology efficacy studies in the therapeutic areas of inflammation, pain,
metabolic diseases etc. Inhouse bred and imported animals would be used in the studies.
Inflammation and Pyrogen
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LPS induced sepsis model in mice.
Adjuvant induced arthritis model in rats
Collagen induced arthritis model in mice
Carrageenan induced paw oedema model
Rat air pouch model
Metabolic disorders
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Pain
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Diabetic Neuropathy models
STZ and nSTZ induced Diabetes modelslHFD + STZ induced Diabetes Models
Genetically Modified mice (Lepr db/db mice )
Formalin induced pain in rats
Acetic acid induced writhing model in Swiss albino mice
Evaluation of analgesic activity by Tail flick
Apparatus and Eddy's hot plate methods.
Oncology
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Subcutaneous xenograft models
Orthotopic tumor models
Metastatic models
Syngeneic models
Hollow fibre assay
Infective
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LD50 determination (Systemic infection or Mouse protection model)
Thigh infection model
Lung infection model
4. Chromosoft drug discovery NETWORK Regulatory management Services TOOLS 9952968059
Toxicology
CRCDrug discovery Network has facilities and expertise to perform all aspects of health and environmental
safety testing with animals. We continue to develop new techniques in line with SOP based system with
advances in regulatory requirements and also constantly working towards 3R principle.
GUIDELINES FOLLOWED
OECD, OCSPP (OPPTS), EC, ICH, Schedule Y, ISO and custom design
In vivo TOXICOLOGY STUDIES (5 pack studies for Agro compounds)
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Acute oral Toxicity - Up an d Down procedure (UDP)
Acute oral Toxicity -Toxic Class method
Acute Dermal Toxicity (Rat/Rabbit)
Acute Dermal irritation in Rabbit
Acute Eye irritation in Rabbit
Skin sensitization in Guinea pig: Buehler test, Magnusson & Kligman
Repeated Dose 28-Day Toxicity Study in Rodents
90-Day Oral Toxicity in Rodents
ROUTE OF ADMINISTRATION
Oral, Dermal, Intra dermal, Subcutaneous, Intravenous, Intra peritoneal and Intramuscular
GENO-TOXICITY STUDIES
The impact of any chemical on DNA is genotoxic ability of given test item. Effects of chemicals on the genetic
material form an integral part of research and regulatory requirement.
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Ames Test
Chromosomal aberration test
In vivo Micronucleus test
ECO-TOXICOLOGY STUDIES
The impact of chemicals in Eco-system is regulatory requirement. The following studies are conducted to draw
the eco-toxic effect of given test item.
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Algae Growth Inhibition Test
Acute Immobilization Test (Daphnia Sp.,)
Acute Toxicity in Fish
Earthworm, Acute Toxicity Test
Acute Oral Toxicity Test - Japanese Quail
SAFETY PHARMACOLOGY
CENTRAL NERVOUS SYSTEM
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Motor activity
Behavior
Body Temperature
Sensory/ Motor reflexes
CARDIO VASCULAR SYSTEM
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Systolic & Diastolic BP
Mean Arterial Pressure
Heart Rate
5. Chromosoft drug discovery NETWORK Regulatory management Services TOOLS 9952968059
Analytical Chemistry
Analytical Chemistry
CRCDrug discovery Network is equipped with advanced instruments to cater the needs of chemists /researcher
in the area of structural elucidation, mass characterization, determination of true elements, separation science etc.
The following are the list of equipments completely operational by experts in analytical chemistry. In addition
our chemists would offer on need basis, suggestion, help and inputs for any of our client needs / problems etc.
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High performance Liquid Chromatography (HPLC)
o HPLC- Analytical
o HPLC- Preparative
High performance Thin Layer Chromatography (HPTLC)
Nuclear Magnetic Resonance Spectroscopy (NMR)
Gas Chromatography coupled with Mass Spectrometry (GCMS)
Inductive coupled plasma Mass Spectrometry (ICPMS)
High performance Liquid Chromatography (HPLC)
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HPLC Method Development (Analytical/Bioanalytical)
HPLC Method Validation (Analytical / Bioanalytical)
HPLC Qualitative analysis
HPLC Quantitative analysis
HPLC Routine sample analysis or Subject sample analysis
Pharmacokinetics studies using HPLC
High performance Thin Layer Chromatography (HPTLC)
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HPTLC Method Development
HPTLC Method Validation
HPTLC Qualitative analysis (Profiling / finger printing)
HPTLC Quantitative analysis
HPTLC Stability Sample analysis
HPTLC Routine sample analysis or Subject sample analysis
Nuclear Magnetic Resonance Spectroscopy (NMR)
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1H -Proton NMR
13C NMR
Cosy
Nosy
DEBT 135
HMQC
HSQC
HMBC
APT
Gas Chromatography coupled with Mass Spectrometry (GCMS)
GCMS Method Development (Analytical/Bioanalytical)
GCMS Method Validation (Analytical/Bioanalytical)
GCMS Qualitative analysis
GCMS Quantitative analysis
GCMS Routine sample analysis or Subject sample analysis
Pharmacokinetics studies using GCMS
6. Chromosoft drug discovery NETWORK Regulatory management Services TOOLS 9952968059
Inductive coupled plasma Mass Spectrometry (ICPMS)
ICPMS techniques are robust and suitable methods of trace metals analysis amenable to a wide array of sample
types. Metals, plastics, proteins, ceramics many others can be successfully analyzed using ICPMS methods.
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Total sulfur and sulfur species in hydrocarbon fuels
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Organotin species in marine sediments and biota, consumer goods, and drinking water
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Mercury species in fish, industrial discharges, and petroleum processing
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Arsenic species in marine algae, food products, and drinking water
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Brominated and phosphorus-based flame retardants in consumer goods
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Phosphorus and sulfur in biological samples
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Protein- and peptide-bound metals
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Pesticides and herbicides
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Chemical warfare agents
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Volatile organohalides in air samples
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Bio-Analytical
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Ongoing Projects
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Patent Works: New Molecule Identification, Drug Discovery-ADEMT TOX Studies
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Medicinal / Phyto Chemistry Lab work Studies
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Structural Interpertation, X-ray Crystalography, Structure Identification, Docking Studies
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(Our Clients / On going projects)
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IPR
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Research