In vitro methods for key aspects of cosmetic safety, including skin and eye irritation and skin sensitisation, are now in widespread use for regulatory safety testing around the world. In many cases, they are now established as the default rather than the alternative approach, so it’s timely to ask, “where next?”
In vitro technologies offer so much more than basic regulatory compliance, and when used wisely, can provide the competitive edge, from ensuring that formulations are fully optimised before proceeding to human in vivo studies, to providing detailed mechanistic data for claim support purposes. Importantly, they are a powerful tool to support the current move towards exposure-led safety assessments, enhancing the long-term safety of products and limiting the risk of post-market adverse events.
This presentation, first shared at the Cosmetics Business Regulatory Summit 2018, examines case studies from some early-adopters who are taking the application of in vitro data to the next level and considers the feasibility of applying exciting new techniques to the cosmetics of the future.
In this presentation, first given at the SCS Science in a Bottle conference 2018, we share the results of our latest in vitro skin sensitisation tests, discuss whether finished products or mixtures can be tested in vitro, reveal progress towards a new model for predicting mildness to skin and how we used mechanistic data to assess antioxidant activity.
Troy Seidle is Director of Research & Toxicology for Humane Society International.
He manages the AXLR8 (pronounced “accelerate”) project, which aims to hasten the transition toward animal-free approaches to safety testing through internationally coordinated research and development.
Dr Carol Treasure's presentation to Cosmetics Business Regulatory Summit 2019 about the results of a 2 year R&D programme into supporting mildness claims. Essential reading for beauty brands and formulators looking for new methods to detect subtle differences between ultra-mild ingredients and products.
Get it Here - Cruelty Free Cosmetics - Resources for Healthy Children www.scribd.com/doc/254613619 ~ choosecrueltyfree.org.au - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
In this presentation, Joseph Campos of Children’s National Medical Center discusses healthcare and laboratory testing using Lean, and the 5 Lean principles that apply to the laboratory. He shares three case studies from his lab: microbiology lab workload and staffing data, microbiology incoming work cell and automated culture plate inoculation. Joe also discusses the difference between and traditional approach to microbiology testing versus a Lean approach.
Strategies for Effective Bioburden and Aseptic ControlMilliporeSigma
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. MilliporeSigma’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
In this presentation, first given at the SCS Science in a Bottle conference 2018, we share the results of our latest in vitro skin sensitisation tests, discuss whether finished products or mixtures can be tested in vitro, reveal progress towards a new model for predicting mildness to skin and how we used mechanistic data to assess antioxidant activity.
Troy Seidle is Director of Research & Toxicology for Humane Society International.
He manages the AXLR8 (pronounced “accelerate”) project, which aims to hasten the transition toward animal-free approaches to safety testing through internationally coordinated research and development.
Dr Carol Treasure's presentation to Cosmetics Business Regulatory Summit 2019 about the results of a 2 year R&D programme into supporting mildness claims. Essential reading for beauty brands and formulators looking for new methods to detect subtle differences between ultra-mild ingredients and products.
Get it Here - Cruelty Free Cosmetics - Resources for Healthy Children www.scribd.com/doc/254613619 ~ choosecrueltyfree.org.au - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
In this presentation, Joseph Campos of Children’s National Medical Center discusses healthcare and laboratory testing using Lean, and the 5 Lean principles that apply to the laboratory. He shares three case studies from his lab: microbiology lab workload and staffing data, microbiology incoming work cell and automated culture plate inoculation. Joe also discusses the difference between and traditional approach to microbiology testing versus a Lean approach.
Strategies for Effective Bioburden and Aseptic ControlMilliporeSigma
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. MilliporeSigma’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
The slide show attached is from a webinar given by Airmid Healthgroup in particularly the team that run the health friendly air™ division. It is a broad overview of issues relating to optimising the indoor environment for health and well-being.
In addition to the health friendly air program airmid healthgroup regularly conducts major environmental field studies in homes throughout the USA and Europe as a key part in assessing the impact of a product or service on indoor air quality and health. These studies produce highly valuable data by quantifying the level of reduction in bio-aerosols achieved in a real world situation.
They provide the opportunity for a company to move up the value chain and establish a strong evidence based premium position over their competitors by focusing on health in the home.
The quality of indoor air has deteriorated as we increasingly seal up our homes for energy efficiency. The consequential effects on health are evidenced by the numbers of people suffering from asthma and allergies. In the USA alone, it is estimated by the Asthma and Allergy Foundation of America that almost 70% of homes have occupants who can be defined as sufferers. Any product or service which can be proven by established data to reduce allergen levels in the home will be of considerable interest and importance to a significant proportion of the population.
Particulates including allergen, bacteria and mold can be measured both in surface and airborne samples. Particle size in the breathing zone can also be assessed, which is of importance due to the risk associated with inhalation of small particles. A particle size of less than 10μm has been associated with adverse health effects and this is more pronounced at particle sizes less than 2.5μm. This is reinforced by the WHO and EPA stance on particle size. Sampling is carried out by our qualified occupational hygienists and all samples are processed and analysed at our accredited facilities.
We customise the studies to meet the requirements of the client, providing advice and sourcing the type and number of homes required in order to achieve high quality and meaningful statistical data on the efficacy of the product or service being studied.
If you have any questions please contact: Graeme Tarbox; gtarbox@airmidhealthgroup.com
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
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.
OECD Webinar | OECD Alternatives to in vivo eye irritation testing - Bertrand...OECD Environment
On 27 September 2019, Anne Gourmelon of the Environment Directorate presented an overview of the various alternative test methods developed as OECD Test Guidelines and relevant guidance material to address eye irritation and serious eye damage for hazard classification of chemicals.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Endotoxin Control and Clearance in BiomanufacturingMilliporeSigma
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Steramist is the only system in the world capable of a 99.9999% kill of Covid-19. It was developed by DARPA as a result of the 2001 United States biological attack using weaponised anthrax known as Amerithrax.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Advances in in vitro testing for regulatory compliance in the chemical industryDr Carol Barker-Treasure
This presentation, originally shared at the Chemical Hazards Communication Society in 2018, discusses the regulatory status of in vitro safety assessments for REACH, CLP Regulation and Biocidal Products Regulation, gives an overview of current key methods for skin irritation, genotoxicity and acute toxicity, shows how finished mixtures or products can be tested, how to interpret results and barriers to progress towards an entirely animal-free testing strategy.
Press Release from CeeTox, PETA and VITOAn Van Rompay
1) Press release:CeeTox today reports the positive results of a PETA-funded validation study for a Non-animal Skin Allergy Assay, SenCeeTox, performed by Flemish Institute of Technology Research (VITO)’s – Applied BIO & Molecular Systems (ABS) team.
2) ABOUT VITO – TEAM ABS:
VITO is an independent and customer-oriented research and technology organization (RTO), we provide innovative technological solutions as well as scientifically based advice and support in order to stimulate sustainable development. ABS offers (i) Research & Development: application and development of biological and molecular methods for human health diagnostics and biomonitoring (ii) Validation of alternative biological test methods (RRR principles) and (iii) GLP/non-GLP contract testing: alternative methods, biodegradation and ecotoxicity. For more information, please visit www.vito.be
The slide show attached is from a webinar given by Airmid Healthgroup in particularly the team that run the health friendly air™ division. It is a broad overview of issues relating to optimising the indoor environment for health and well-being.
In addition to the health friendly air program airmid healthgroup regularly conducts major environmental field studies in homes throughout the USA and Europe as a key part in assessing the impact of a product or service on indoor air quality and health. These studies produce highly valuable data by quantifying the level of reduction in bio-aerosols achieved in a real world situation.
They provide the opportunity for a company to move up the value chain and establish a strong evidence based premium position over their competitors by focusing on health in the home.
The quality of indoor air has deteriorated as we increasingly seal up our homes for energy efficiency. The consequential effects on health are evidenced by the numbers of people suffering from asthma and allergies. In the USA alone, it is estimated by the Asthma and Allergy Foundation of America that almost 70% of homes have occupants who can be defined as sufferers. Any product or service which can be proven by established data to reduce allergen levels in the home will be of considerable interest and importance to a significant proportion of the population.
Particulates including allergen, bacteria and mold can be measured both in surface and airborne samples. Particle size in the breathing zone can also be assessed, which is of importance due to the risk associated with inhalation of small particles. A particle size of less than 10μm has been associated with adverse health effects and this is more pronounced at particle sizes less than 2.5μm. This is reinforced by the WHO and EPA stance on particle size. Sampling is carried out by our qualified occupational hygienists and all samples are processed and analysed at our accredited facilities.
We customise the studies to meet the requirements of the client, providing advice and sourcing the type and number of homes required in order to achieve high quality and meaningful statistical data on the efficacy of the product or service being studied.
If you have any questions please contact: Graeme Tarbox; gtarbox@airmidhealthgroup.com
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
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.
OECD Webinar | OECD Alternatives to in vivo eye irritation testing - Bertrand...OECD Environment
On 27 September 2019, Anne Gourmelon of the Environment Directorate presented an overview of the various alternative test methods developed as OECD Test Guidelines and relevant guidance material to address eye irritation and serious eye damage for hazard classification of chemicals.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Endotoxin Control and Clearance in BiomanufacturingMilliporeSigma
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Steramist is the only system in the world capable of a 99.9999% kill of Covid-19. It was developed by DARPA as a result of the 2001 United States biological attack using weaponised anthrax known as Amerithrax.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Advances in in vitro testing for regulatory compliance in the chemical industryDr Carol Barker-Treasure
This presentation, originally shared at the Chemical Hazards Communication Society in 2018, discusses the regulatory status of in vitro safety assessments for REACH, CLP Regulation and Biocidal Products Regulation, gives an overview of current key methods for skin irritation, genotoxicity and acute toxicity, shows how finished mixtures or products can be tested, how to interpret results and barriers to progress towards an entirely animal-free testing strategy.
Press Release from CeeTox, PETA and VITOAn Van Rompay
1) Press release:CeeTox today reports the positive results of a PETA-funded validation study for a Non-animal Skin Allergy Assay, SenCeeTox, performed by Flemish Institute of Technology Research (VITO)’s – Applied BIO & Molecular Systems (ABS) team.
2) ABOUT VITO – TEAM ABS:
VITO is an independent and customer-oriented research and technology organization (RTO), we provide innovative technological solutions as well as scientifically based advice and support in order to stimulate sustainable development. ABS offers (i) Research & Development: application and development of biological and molecular methods for human health diagnostics and biomonitoring (ii) Validation of alternative biological test methods (RRR principles) and (iii) GLP/non-GLP contract testing: alternative methods, biodegradation and ecotoxicity. For more information, please visit www.vito.be
Meeting the Global Challenge - A Guide to Assessing the Safety of Cosmetics w...v2zq
Meeting the Global Challenge - A Guide to Assessing the Safety of Cosmetics without Using Animals - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~chemicalwatch.com/
Thermo Fisher Scientific India Pvt. Ltd. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and approximately 55,000 employees globally. Our mission through our premier brands Thermo Scientific, Applied Bio Systems, Invitrogen, Fisher Scientific and Unity Lab Services, we offer an unmatched combination of innovative is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. We offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
A presentation given as part of a webinar hosted by PETA's International Science Consortium on replacing foetal bovine serum in cell culture media. Includes case study on skin sensitisation testing
Validating microbiome claims – including the latest DNA techniquesEagle Genomics
Abel Ureta-Vidal, Founder and CEO of Eagle Genomics, discusses how advanced DNA techniques help us to identify and characterise the microbiome, leading us to ways to prove cosmetic claims at the in-cosmetics formulation summit, 25th October 2017.
Best Practices for Building an End-to-End Workflow for Microbial GenomicsJonathan Jacobs, PhD
Invited talk presented at 2019 CAFPA-ASM D.C. Branch
FALL MEETING on "Current Testing Approaches & Implications for Public Health" at the FDA in College Park, MD.
This presentation was given at a March 2013 meeting of the HEA STEM Special Interest Group on teaching ethics to bioscience students. The meeting was hosted at the University of Northampton, UK, and the principal focus was on teaching about Ethics and Risk.
Professor Joe Perry is a member of the European Food Safety Authority (EFSA).
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Similar to Safer cosmetics through in vitro science. XCellR8 presentation to Cosmetics Business Regulatory Summit 2018 (20)
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Richard's entangled aventures in wonderlandRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...Sérgio Sacani
Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
on Io’s surface have been monitored from both spacecraft and ground-based telescopes.
Here, we present the highest spatial resolution images of Io ever obtained from a groundbased telescope. These images, acquired by the SHARK-VIS instrument on the Large
Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
show that a plume deposit from a powerful eruption at Pillan Patera has covered part
of the long-lived Pele plume deposit. Although this type of resurfacing event may be common on Io, few have been detected due to the rarity of spacecraft visits and the previously low spatial resolution available from Earth-based telescopes. The SHARK-VIS instrument ushers in a new era of high resolution imaging of Io’s surface using adaptive
optics at visible wavelengths.
The increased availability of biomedical data, particularly in the public domain, offers the opportunity to better understand human health and to develop effective therapeutics for a wide range of unmet medical needs. However, data scientists remain stymied by the fact that data remain hard to find and to productively reuse because data and their metadata i) are wholly inaccessible, ii) are in non-standard or incompatible representations, iii) do not conform to community standards, and iv) have unclear or highly restricted terms and conditions that preclude legitimate reuse. These limitations require a rethink on data can be made machine and AI-ready - the key motivation behind the FAIR Guiding Principles. Concurrently, while recent efforts have explored the use of deep learning to fuse disparate data into predictive models for a wide range of biomedical applications, these models often fail even when the correct answer is already known, and fail to explain individual predictions in terms that data scientists can appreciate. These limitations suggest that new methods to produce practical artificial intelligence are still needed.
In this talk, I will discuss our work in (1) building an integrative knowledge infrastructure to prepare FAIR and "AI-ready" data and services along with (2) neurosymbolic AI methods to improve the quality of predictions and to generate plausible explanations. Attention is given to standards, platforms, and methods to wrangle knowledge into simple, but effective semantic and latent representations, and to make these available into standards-compliant and discoverable interfaces that can be used in model building, validation, and explanation. Our work, and those of others in the field, creates a baseline for building trustworthy and easy to deploy AI models in biomedicine.
Bio
Dr. Michel Dumontier is the Distinguished Professor of Data Science at Maastricht University, founder and executive director of the Institute of Data Science, and co-founder of the FAIR (Findable, Accessible, Interoperable and Reusable) data principles. His research explores socio-technological approaches for responsible discovery science, which includes collaborative multi-modal knowledge graphs, privacy-preserving distributed data mining, and AI methods for drug discovery and personalized medicine. His work is supported through the Dutch National Research Agenda, the Netherlands Organisation for Scientific Research, Horizon Europe, the European Open Science Cloud, the US National Institutes of Health, and a Marie-Curie Innovative Training Network. He is the editor-in-chief for the journal Data Science and is internationally recognized for his contributions in bioinformatics, biomedical informatics, and semantic technologies including ontologies and linked data.
Safer cosmetics through in vitro science. XCellR8 presentation to Cosmetics Business Regulatory Summit 2018
1. Safer Cosmetics Through
In Vitro Science
Dr Carol Treasure
Founder & CEO, XCellR8 Ltd
carol.treasure@x-cellr8.com
@XCellR8_Labs
XCellR8; Dr Carol Treasure
2. About XCellR8
• XCellR8 provides 100% animal-free safety and
efficacy tests to the cosmetics and chemical industries
• Our mission: To accelerate the world’s transition to
100% animal-free testing through our scientifically
advanced and ethical approach
• Key clients include global cosmetic companies
including Lush and The Body Shop, ingredient
suppliers such as Croda and Innospec and SMEs
XCellR8 is GLP accredited by the MHRA for regulatory in vitro safety testing
Founded 2008 by
Bushra Sim and Dr Carol TreasureOur laboratory at Sci-Tech Daresbury Celebrating our 10th birthday
3.
4. INTERNATIONAL
REGULATORY INFLUENCE
• Participation at OECD
Expert Working Groups
• OECD and ECHA
approval for animal-
product-free adaptations
of regulatory methods
GLOBAL THOUGHT
LEADERSHIP
• International conferences,
panels, debates, working groups
• Invited participant at the United
Nations General Assembly Sept
2018
INNOVATION / RESEARCH &
DEVELOPMENT
• Grants from Innovate UK
and the European Horizon
2020 programme to fund
the development of new in
vitro tests for acute toxicity
and mildness to skin
Our work beyond in vitro safety testing
5. The global
sustainability agenda
• 80% of countries still allow animal testing
for cosmetics
• This is now part of the United Nations’ 2030
Agenda: 17 Sustainability Development Goals
• SDG12: Sustainable Production and Consumption
• 12.8: “By 2030, ensure that people
everywhere have the relevant information and
awareness for sustainable development and
lifestyles in harmony with nature”.
• Watch our debate at the UN General
Assembly held on 27th Sept 2018
THE ROLE OF
100% ANIMAL-FREE TESTING
6. Are “alternatives” still alternative?!
Some “alternatives” are now
mainstream and adopted as the default
test methods for regulatory safety
testing eg REACH, CLP
• Extensive validation trials
(enhanced human safety)
• High level of confidence
internationally
• Large amount high quality of data
7. The “1R” journey
In
vivo
In
vitro
“3D” reconstructed
human skin cultures
(EpiDerm™)
“3D” human airway
epithelium,
(EpiAirway™)
Organ-on-a-chip
Genomic screening
(Senzagen
GARDSkin™)
Mechanistic tests
(anti-oxidant)
Animal-product-
free cell culture
Microbiome
3D bioprinting
Advanced in vitro:
Maximal human relevance
1R = Replacement
Huge progress over the last 20 years - uptake by industry is the key to the future!
8. Shifting the emphasis
From “No animal testing”
To “How do you test your
products and ingredients?”
Finished product testing is increasingly
important, helping companies to satisfy
consumer demands and go beyond the
“bare minimum” of a safety assessment
that relies on historical animal data for
ingredients
Instagram influencers visit the
XCellR8 lab to understand how
The Body Shop tests its ingredients
Well informed consumers
increasingly demand to know how
products are tested
10. Why animal-product-free (APF)?
Scientific advantages:
• Better model of human physiology
• Higher reproducibility (synthetic components)
Ethical advantages:
• Avoids animal welfare issues, eg Foetal Bovine Serum
(FBS) collection
• Helps companies meet consumer demands for
sustainable, ethical products with transparent supply chains
• Vegan compliant (and Halal?)
Uniquely, everything we do at XCellR8 is animal-product-free
Most in vitro methods still use animal-derived components
such as serum, tissue extracts and antibodies, so they still
require the sacrifice of animals and are not truly “animal-free”.
Uniquely, everything we do at XCellR8 is animal-product-free
(sometimes described as “vegan testing”)
11. Meeting consumer demands for ethical, safe
and sustainable cosmetics
Belot, N., Sim, B., Longmore, CL., Roscoe, L. and Treasure, C. (2017)
Adaptation of the KeratinoSens™ skin sensitisation test to
animal-product-free cell culture
http://www.altex.ch/resources/altex_2017_4_560_564_SC_Belot1.pdf
100% ANIMAL-FREE SKIN SENSITISATION TESTING
Edwards et al (2018)
Adaptation of the human Cell Line activation Test (h-CLAT)
to Animal-Product-Free Conditions
https://www.altex.org/publib/Edwards_of_180613_v2.pdf
Published in
ALTEX
12. Skin sensitisation adverse outcome pathway (AOP)
Regulatory guidance: “2 out of 3” approach
SENSITISER
T-CELL
1
2
KERATINOCYTES
CONTACT
Inflammatory Cytokine Release
3
4
LYMPHOCYTE PROLIFERATION
DENDRITIC
CELLS
MIGRATION TO LOCAL LYMPH
NODE
5
Key Events In Skin Sensitisation and
Related Tests
1. Contact
(Direct Peptide Reactivity Assay – DPRA)
2. Release of Pro-Inflammatory Cytokines by
Keratinocytes (KeratinoSensTM)
3. Dendritic Cell Activation/Maturation
(human Cell Line Activation Test – h-CLAT)
4. Migration
5. T-cell Proliferation
(Local Lymph Node Assay - LLNA)
13. Animal-product-free
(APF) adaptation of
KeratinoSens™
• Replaced foetal bovine serum (FBS) and porcine
culture reagents with human-based or synthetic
alternatives
• All 20 reference chemicals correctly classified in
line with Validated Reference Method (VRM)
• Data accepted by the OECD Expert Working
Group on Skin Sensitisation and WNT National
Co-Ordinators’ Committee
• Adapted method published as an Annex to the
VRM in the new version of OECD TG 442d 2018
• Therefore full acceptance as a regulatory
method
14. Animal-product-free
adaptation of h-CLAT
• Replaced foetal bovine serum (FBS), porcine
culture reagents and mouse-derived antibodies
with human-derived or synthetic alternatives
• All proficiency chemicals correctly classified –
equivalence with Validated Reference Method
(VRM)
• Data reviewed favourably by the OECD’s WNT
National Co-Ordinators’ Committee and adaptation
to TG442e will be discussed by Expert Working
Group in November 2018
• Data may be used in REACH submissions
supported by in-house validation results
16. Skin sensitisation test results for a cosmetic ingredient
0
20
40
60
80
100
120
140
160
180
0.000
0.500
1.000
1.500
2.000
2.500
3.000
3.500
4.000
Percentageviabilityrelativetountreated
control(greyline)
FoldInduction(pinkbars)
Test item concentration (µg/ml)
KeratinoSens™ Test Results for a Cosmetic Ingredient
DPRA RESULTS FOR A COSMETIC INGREDIENT
Classification: Sensitiser
% cysteine depletion % lysine depletion Mean % peptide
depletion
Reactivity class Classification
32.3% 11.3% 21.8% Low Sensitiser
Overall “2 out of 3” classification:
Sensitiser
KERATINOSENS™ RESULTS
FOR A COSMETIC INGREDIENT
Classification: Sensitiser
17. Case study: Building in vitro data for
safer cosmetics
• Over the past 4 years, over 1,000 safety tests
on Lush ingredients & finished products
• Genotoxicity (450 ingredients)
• Skin sensitisation (including 140 finished products)
• Skin irritation
• Eye irritation
18. Building In Vitro data
for safer cosmetics;
the problem with safety data
sheets (SDS)
“One of the frustrations for us is that
whenever we receive a Material Safety
Data Sheet from an ingredient supplier it
always contains animal test data - usually
downloaded from the internet. We have to
do better than that.“
KARL BYGRAVE, DIRECTOR, LUSH
Read more >
19. Building in vitro data for safer cosmetics
• Advantages of an animal-free safety database for safety
assessment and product development
• Greater relevance to human physiology
• Higher confidence due to extensive validation of in vitro methods
• In vitro data provides a reliable, quick and often cost-effective
prelude to testing on human volunteers
• Learning more about the predictive capacity of the tests
• Encourage suppliers to test ingredients using animal-free
methods
20. Trend towards exposure-led safety assessment
High quality information for the safety assessment process
(includes in silico; in vitro; exposure-based scenarios using
parameters such as TTC* and DST* as endorsed by RIFM;
clinical testing)
*TTC – Threshold of Toxicological Concern; DST = Dermal Sensitisation Threshold
22. Can finished products be tested in vitro?
Method Regulatory Test Guideline Suitable for finished
products?
Eye Irritation (reconstructed
human cornea)
OECD TG 492 Yes
Skin Irritation (reconstructed
human skin)
OECD TG 439 Yes
Skin Sensitisation (DPRA) OECD TG 442C Yes (only for “mixtures of
known composition”)
Skin Sensitisation
(KeratinoSens)
OECD TG 442D Yes (limitations: solubility;
cytotoxicity)
Skin Sensitisation (h-CLAT) OECD TG 442E Yes (limitations: solubility;
cytotoxicity)
23. Skin sensitisation test results
for a bath bomb
To consider: classification threshold; compare with known human in vivo responses
Overall “2 out of 3” classification: Non-Sensitiser
24. Further reading
• Getting under the skin of
in vitro skin sensitisation
testing ebook
• Topics include potency
assessment and testing
finished products
Download your copy >
Available at x-cellr8.com/in-vitro-skin-sensitisation-testing/
26. Human in vitro / in vivo correlation of skin
mildness data for consumer products
• Innovate UK funded 2 year project
• Collaboration with Cutest, UK
• Optimise sensitive methods for assessing mild products
and ingredients
• Directly compare in vitro data with in vivo human patch
test data
• Includes funded industry case studies (PZ Cussons,
The Body Shop)
Contact us if you are interested in a funded case study for your company
27. In vitro skin mildness test
• 3D human tissue models, grown at the
air-liquid interface
• Suitable for testing ingredients and finished
products
• Applied directly to the tissue surface; good
model of “real life” exposure
• Classifies as Severe, Moderate, Mild or
Minimal / Non-Irritant
• “ET50” values allow rank order of mildness
to be determined in comparison with other
formulations / competitor and market leading
products
0.000
20.000
40.000
60.000
80.000
100.000
120.000
0 20 40 60 80 100 120
Percentageofviabilityrelativeto
NegativeControl
Time (minutes)
ET50 Calculation: SLS
Project will include additional markers such as cytokine release
28. Skin irritation
potential (mildness)
of surfactants
Skin Irritation Result ET50 Rank Position
Non Irritating >45 hrs 1
Non Irritating >45 hrs 1
Very Mild 12-18 hrs 2
Moderate to Mild 9.36 hrs 3
Moderate to Mild 7.46 hrs 4
Moderate to Mild 6.65 hrs 5
Moderate to Mild 5.33 hrs 6
Moderate 2.90 hrs 7
Moderate 2.29 hrs 8
Moderate 2.27 hrs 9
Moderate <2 hrs 10
Moderate <2 hrs 10
Moderate 1.38 hrs 11
Moderate 0.65 hrs 12
Moderate 0.56 hrs 13
Strong/Severe <0.5 hrs 14
Strong/Severe <0.5 hrs 14
Least irritating
(mildest)
Most irritating
Same methodology can be used to test eye mildness eg baby bath products
31. Genomic screening: the next generation
of skin sensitisation tests?
GARD measures the responses of >200 biomarkers and can predict potency of skin sensitisers
32. Microbiome – is it a skincare trend that’s
here to stay?
In vitro methods are available and undergoing further development
Recent Global Cosmetics News podcast: https://tinyurl.com/ybvjsdba
33. Personalised testing?
The technology is available for personalised
skin models – but it’s an expensive approach.
Will they ever be in real demand?