Advion Bioanalytical Labs is now part of Quintiles, a global clinical research organization. Advion provides bioanalytical laboratory testing and clinical development services across the drug development lifecycle using highly qualified staff and state-of-the-art facilities. Their services include GLP-compliant small molecule and biotherapeutic bioanalysis by LC/MS and immunoassays, in vitro ADME and metabolism identification assays, biomarker testing, and clinical sample management through Quintiles' global network. Advion has over 20 years of experience in regulated bioanalysis and a reputation for scientific excellence.
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
GPCR ligand screening assay
Monitors the very early activation stage of Frizzled-Receptors of the GPCR group
Our assay can be implemented in a cell-free chemical compound high-throughput target screening. GPCR is the largest known category of molecular targets with verified therapeutic value. Up to 40% of approved drugs are targeted to GPCRs. 25% of the top 200 best-selling drug targets are GPCRs.
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
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.
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.
Historically, genetic toxicology has been comprised of bacterial and cell based in vitro assays such as the Ames assay (a bacterial mutagenicity assay), Micronucleus and Chromosomal Aberration assays (mammalian cytogenetic assays), and Mouse Lymphoma Assay (in vitro mammalian cell gene mutation assay). These were routinely used for safety evaluation and are still part of the standard core battery. The emergence of new technologies has facilitated the development of in vitro methods for safe and effective drug and chemical testing.
This BioReliance® toxicology services webinar will explore alternative models, including 3D skin models that comply with the EC Scientific Committee on Consumer Safety (SCCS) recommendations. It will also discuss how the 3Rs (Replace, Reduce, Refine) Principle advocates the exploration of such alternative methods while achieving required goals.
In this webinar, you will learn:
• About in vitro alternatives to animal toxicity testing in pharma, chemical, tobacco, and personal care products.
• How the 3Rs (Replace, Reduce, Refine) Principle advocates exploring alternative methods without compromising the required goals.
• Alternatives to comply with the 7th Amendment to the EC Cosmetics Directive.
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
GPCR ligand screening assay
Monitors the very early activation stage of Frizzled-Receptors of the GPCR group
Our assay can be implemented in a cell-free chemical compound high-throughput target screening. GPCR is the largest known category of molecular targets with verified therapeutic value. Up to 40% of approved drugs are targeted to GPCRs. 25% of the top 200 best-selling drug targets are GPCRs.
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
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.
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.
Historically, genetic toxicology has been comprised of bacterial and cell based in vitro assays such as the Ames assay (a bacterial mutagenicity assay), Micronucleus and Chromosomal Aberration assays (mammalian cytogenetic assays), and Mouse Lymphoma Assay (in vitro mammalian cell gene mutation assay). These were routinely used for safety evaluation and are still part of the standard core battery. The emergence of new technologies has facilitated the development of in vitro methods for safe and effective drug and chemical testing.
This BioReliance® toxicology services webinar will explore alternative models, including 3D skin models that comply with the EC Scientific Committee on Consumer Safety (SCCS) recommendations. It will also discuss how the 3Rs (Replace, Reduce, Refine) Principle advocates the exploration of such alternative methods while achieving required goals.
In this webinar, you will learn:
• About in vitro alternatives to animal toxicity testing in pharma, chemical, tobacco, and personal care products.
• How the 3Rs (Replace, Reduce, Refine) Principle advocates exploring alternative methods without compromising the required goals.
• Alternatives to comply with the 7th Amendment to the EC Cosmetics Directive.
Diagnostic Medical Microbiology - Traditional and Modern approachChhaya Sawant
Updated version of Diagnostic Microbiology - Traditional and Modern approach. The presentation is an overview of conventional techniques still used in many laboratories and new technologies such as Molecular- and Protein-based testing
Abstract:
Cell and gene therapies, well recognized as the drug revolution for this decade, are booming in Asian countries. Several cell and gene therapeutic products launched successfully in Europe and the US. The commercialization of these therapies is a hot topic, while ensuring product safety, especially quality for the new modalities, raises challenges within the industry. As a globally leading biosafety testing provider, Merck is committed to optimizing and advancing innovation and development of biosafety testing. As your reliable partner in CMC consideration, our comprehensive solutions for cell and gene therapy biosafety testing enable regulatory compliance. This presentation will cover rationale and methodologies for cell and gene therapy product testing from Merck’s BioReliance® testing portfolio, as well as provide an overview of our testing capabilities and services.
Overview Radboudumc Center for Proteomics, Glycomics and Metabolomics april 2015Alain van Gool
An overview of the proteomics, glycomics and metabolomics expertise and capabilities within the Translational Metabolic Laboratory of the Radboudumc. We're interested in collaboration with academic and industrial partners, either bilateral or as part of multi-partner consortia.
Microbiome Identification to Characterization: Pathogen Detection Webinar Ser...QIAGEN
The research community has begun correlating the makeup of individual microbiomes with disorders and diseases such as autism, atherosclerosis, obesity and cancer. To accomplish this, researchers must first identify and characterize these microbial communities. This slidedeck will begin with a general introduction of metagenomics and an overview of experimental strategies. Following this, a comprehensive microbiome assay pipeline will be introduced. We conclude with application-based examples that demonstrate how to identify and characterize microbiome profiles.
Breaking the Status Quo: Using Mass Spectrometry to detect Host Cell ProteinsMilliporeSigma
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
GVK Biosciences (GVK BIO) offers screening services for drug discovery to determine biological activity and properties customized to meet the research needs of the Pharma and Biotech industries. Our range of assays include Biochemical, Cellular, ADME assays & Animal models for profiling of NCEs for Potency, Selectivity, Efficacy, Drugability and Toxicity.
T1D Exchange is a not for profit organization whose mission is to accelerate therapies to the market to improve health outcomes on a path to a cure to type 1 diabetes. T1D Exchange possesses a clinic network of 69 clinics, a patient registry of 27,000 patients, a biorepository, and a patient engagement platform that builds an online community for people with type 1 diabetes.
Diagnostic Medical Microbiology - Traditional and Modern approachChhaya Sawant
Updated version of Diagnostic Microbiology - Traditional and Modern approach. The presentation is an overview of conventional techniques still used in many laboratories and new technologies such as Molecular- and Protein-based testing
Abstract:
Cell and gene therapies, well recognized as the drug revolution for this decade, are booming in Asian countries. Several cell and gene therapeutic products launched successfully in Europe and the US. The commercialization of these therapies is a hot topic, while ensuring product safety, especially quality for the new modalities, raises challenges within the industry. As a globally leading biosafety testing provider, Merck is committed to optimizing and advancing innovation and development of biosafety testing. As your reliable partner in CMC consideration, our comprehensive solutions for cell and gene therapy biosafety testing enable regulatory compliance. This presentation will cover rationale and methodologies for cell and gene therapy product testing from Merck’s BioReliance® testing portfolio, as well as provide an overview of our testing capabilities and services.
Overview Radboudumc Center for Proteomics, Glycomics and Metabolomics april 2015Alain van Gool
An overview of the proteomics, glycomics and metabolomics expertise and capabilities within the Translational Metabolic Laboratory of the Radboudumc. We're interested in collaboration with academic and industrial partners, either bilateral or as part of multi-partner consortia.
Microbiome Identification to Characterization: Pathogen Detection Webinar Ser...QIAGEN
The research community has begun correlating the makeup of individual microbiomes with disorders and diseases such as autism, atherosclerosis, obesity and cancer. To accomplish this, researchers must first identify and characterize these microbial communities. This slidedeck will begin with a general introduction of metagenomics and an overview of experimental strategies. Following this, a comprehensive microbiome assay pipeline will be introduced. We conclude with application-based examples that demonstrate how to identify and characterize microbiome profiles.
Breaking the Status Quo: Using Mass Spectrometry to detect Host Cell ProteinsMilliporeSigma
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
GVK Biosciences (GVK BIO) offers screening services for drug discovery to determine biological activity and properties customized to meet the research needs of the Pharma and Biotech industries. Our range of assays include Biochemical, Cellular, ADME assays & Animal models for profiling of NCEs for Potency, Selectivity, Efficacy, Drugability and Toxicity.
T1D Exchange is a not for profit organization whose mission is to accelerate therapies to the market to improve health outcomes on a path to a cure to type 1 diabetes. T1D Exchange possesses a clinic network of 69 clinics, a patient registry of 27,000 patients, a biorepository, and a patient engagement platform that builds an online community for people with type 1 diabetes.
2. is now
Your global one-source
solution for early clinical
studies and laboratory testing
across the development
spectrum
3. Advion? Quintiles?
What is different?
Then Now with Quintiles
•High Quality Regulated Bioanalytical •High Quality Regulated Bioanalytical
Laboratories for PK/ Immunogenicity/ Laboratories for PK/ Immunogenicity/
Biomarkers Biomarkers
•Automated ADME In Vitro Laboratory •Automated ADME In Vitro Laboratory
•Well Respected Senior Scientific staff •Well Respected Senior Scientific staff
that includes: that includes:
Jack Henion, Steve Lowes, Jack Henion, Steve Lowes,
Gary Schultz, John Perkins, Gary Schultz, John Perkins,
Dan Mulvana, et al. Dan Mulvana, et al.
3
4. Advion Bioanalytical Labs,
A Quintiles Company
Integrated Services
Laboratory and Clinical Development services
across the lifecycle – and the globe
• LC/MS Bioanalytical & Immunoassay
• In Vitro ADME & Metabolism ID
• PK/PD Data Analysis, Modeling and Simulation
• Biomarkers – LC/MS/MS, Immunoassays, and More
• Global Phase I Units & Central Laboratories Network
4
5. Bioanalytical Services
Three Centers of Excellence and Global Capabilities
– LC/MS Bioanalytical (PK and Biomarkers): Ithaca, New York
• GLP-compliant & discovery LC/MS bioanalytical – small molecules
• GLP-compliant LC/MS bioanalytical – biotherapeutics and fit-for-purpose-biomarkers
• Discovery bioanalytical – determine PK profiles of drug candidates
– Immunoassay Bioanalytical (PK and Biomarkers): Manassas, VA
• GLP-compliant & discovery bioanalytical/ligand binding assays – macro molecules
• Immunogenicity – immunoassay and cell-based assays
• Immunoassay fit-for-purpose biomarkers
– In Vitro ADME and Metabolite Identification: Indianapolis, IN
• In vitro assays to determine metabolism, solubility, permeability of drug candidates
• Metabolite profiling and metabolite identification – definitive and discovery
– High Quality Bioanalytical with Quintiles Global Sample Shipping Logistics,
Phase I Clinics Throughout the World, and PK Data Analysis Capabilities
5
6. Our scientific heritage and progression
Jack Henion & Tom Kurz establish Advion , remain engaged and passionate about Advion Bioanalytical Labs (1993)
Name changed to Advion BioSciences (2001)
Creation of BioServices & BioSystems subsidiaries (2001)
Large Investments initiated to pursue the latest technologies (2002-Present)
Opened 33,000 sq ft headquarters and bioanalytical lab in Ithaca, NY (2007)
Opened 10,000 sq ft Immunoassay lab in Manassas, VA (2007)
LC/MS Biomarker services business is launched, Ithaca, NY (2008)
Opened major 22,000 sq ft Discovery/Metabolism Lab in Indianapolis, IN (2011)
One of the largest bioanalytical groups in North America
Advion Bioservices acquired by Quintiles (October 2011)
Part of a Quintiles global network that consists of > 25,000 employees worldwide in 84 countries
6
7. What we are known for
– Established bioanalytical lab with many years of experience
• 19 years of GLP-compliant bioanalytical experience
• Clients include 14 of 15 largest pharmaceutical companies in the world
– Well respected reputation for scientific excellence
• Renowned scientific leadership – Dr. Jack Henion & Dr. Steve Lowes
• Reputation for solving challenging bioanalytical problems others could not
• Pioneered many key industry developments, (e.g., 96-well, Watson LIMS,
biotherapeutic bioanalysis by LC/MS, nanoelectrospray)
• Stringent scientific review of all assays assures the use of rugged, reliable and
reproducible methods
– Leader in bioanalytical GLP compliance
• Dr. Steve Lowes serves on many significant committees, authored guiding papers,
and speaks at major bioanalytical scientific conferences
• Excellent inspection record and reputation for GLP compliance
7
8. Services Overview
Bioanalytical and ADME Services
Small Molecule Biotherapeutics Biomarkers ADME
Bioanalysis Bioanalysis Bioanalysis Assays
(PK & TK Support) (PK & TK Support)
GLP-Compliant LC/MS GLP-Compliant LC/MS Biomarkers In vitro Screening
• Assay method • LC/MS assays • Protein & peptides • Solubility screening
development • Immunoassays • Lipids • Permeability screening
• Method validation • Small molecule • Microsomal clearance
• Sample analysis Discovery
• SISCAPA • Hepatocyte clearance
• Validated assay list • LC/MS assays
• Metabolite stability
• Immunoassays Immunoassays
Discovery LC/MS • Plasma-protein binding
• ELISA
• Plasma and tissue Immunogenicity
• MSD Platform Definitive Assays
• Tier 0 through tier 3 • Screen & confirm
• Validated assay list • Reaction phenotyping
• NAB Assays
Sample Management • CYP450 inhibition
Sample Management
• Global capabilities Sample Management • Plasma- protein binding
• Global capabilities
• Custom kits • Global capabilities
• Custom kits Metabolite ID
• Custom kits
PK Data Analysis • Discovery met ID
PK Data Analysis • Radio-profiling
• Development met ID
9. Drug Development Cycle
Advion Bioanalytical Labs Services
Discovery Advion Services Clinical Phase I Advion Services Phase IV Advion Services
• High-throughput LC/MS bioanalytical • GLP-compliant LC/MS & immunoassay • GLP LC/MS & immunoassay
• High-throughput immunoassay • Immunogenicity • Immunogenicity
• ADME Screening • LC/MS & immunoassay biomarkers • LC/MS & immunoassay
• Definitive ADME assays biomarkers
• Development metabolite ID • Sample management
• Met ID radio-profiling
• Sample management
Discovery Preclinical Phase I Phase II-III Post Marketing
Preclinical Advion Services Clinical Phase II-III Advion Services
• GLP-compliant LC/MS & immunoassay • GLP-compliant LC/MS & immunoassay
• Immunogenicity • Immunogenicity
• LC/MS & immunoassay biomarkers • LC/MS & immunoassay biomarkers
• Definitive ADME assays • Sample management
• Development metabolite ID
• Met ID radioprofiling
9
10. Advion Bioanalytical Labs
– In our 20th year of operation as a GLP bioanalytical lab
– Quality bioanalytical services with a global reach through Quintiles
– A scientific leader in bioanalytical services
• Renowned scientific leadership
• Reputation for scientific excellence & method development
• Outstanding regulatory compliance
• Broad expertise
– LC/MS of small molecules and biologics
– Ligand binding assays
– ADME assays
– Metabolite identification
• Proactive communication from skilled project managers
• Flexibility in scheduling and record of meeting deadlines
• One of the largest bioanalytical lab groups
• Strong synergies with Quintiles Phase I and global sample logistics
10
