Different compounds behave in distinguished manner when tested. A important aspect of compound development is to understand the mode of action of compounds. In order to achieve this goal, IVB use RNAseq and whole transcriptome analysis to assist the findings. Based on the findings, a well-round understanding of a compound can be generated, which assists the research findings in a efficient and timely way.
Good Model Organism for Anti Aging TestingWenlan Hu
Drug testing is taking more attention than ever before in a fast growing market for longevity compounds. In order to succeed in a competitive market and develop a pipeline method for quick drug development, we need to understand and choose the most suitable model organism for aging studies. The following content is intended to provide information on how to choose the best model for anti-aging drug testing.
Finding Optimal Compound Dosage for Anti-Aging DrugsWenlan Hu
Anti-aging compound becomes a very integral part of the compound market. However, the lack of experience in this field makes it very hard for testing CROs to fully understand the mechanism of actions as well as efficacy of the compound, particularly the optimal dosage for anti-aging use. In the following slide we are trying to share with you the best way to do testing on the substances that are designed for anti-aging use.
CRO Company for Mode of Action & Efficacy Test for Drugs | InvivoBiosystemsWenlan Hu
Compound testing takes shares of a huge part of the drug development and health-related compound market. In order to find a CRO that is both friendly for budget saving and efficient at the same time is not easy. IVB uses a three staged compound assessment which includes RNAseq, whole transcriptome analysis, and other techniques to help our clients better understand the mode of action and efficacy of a particular compound.
Low cost nutraceutical hypothesis testingWenlan Hu
The US nutraceutical market is fast growing with increasingly demands on fast and economic nutraceutical testing labs. In order to succeed in a fast growing market, we need to review the market trends as well as the advantages of different model organisms in hypothesis testing.
The compound characterization market is growing increasingly profitable and competitive at the same time. In order to develop a new compound product, the testing step is indispensable. Unlike drug discovery, compound testing is not as restrictive, but understanding the main workflow is still necessary to excel in the market. In order to help you improve both the efficiency and safety of compound testing, we developed the protocol to assist you in your findings.
Alternative animal model for compound characterizationWenlan Hu
To pick a model is not easy thing to do, especially when nutraceutical market needs have to be met. Such market requires low budget, fast turn-around rate, and high-quality data at the same time. Traditional models such as mice and cell cultures usually only meet one need at one time. IVB uses C.elegans and zebrafish which lies in the middle of the model spectrum in terms of the three needs to perfectly accommodate all of them at the same time.
How to model longevity and health effect in 3 monthsWenlan Hu
Healthspan analysis is a huge part of longevity study, which is heavily looked at by many aging labs in recent years. The older we grow, our health will be affected accordingly, and this influence what type of compound we use. To better picture what effects compounds brings to us and to extend lifespan as a goal. A three stage compound assessment is developed by IVB to solve this question.
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
Good Model Organism for Anti Aging TestingWenlan Hu
Drug testing is taking more attention than ever before in a fast growing market for longevity compounds. In order to succeed in a competitive market and develop a pipeline method for quick drug development, we need to understand and choose the most suitable model organism for aging studies. The following content is intended to provide information on how to choose the best model for anti-aging drug testing.
Finding Optimal Compound Dosage for Anti-Aging DrugsWenlan Hu
Anti-aging compound becomes a very integral part of the compound market. However, the lack of experience in this field makes it very hard for testing CROs to fully understand the mechanism of actions as well as efficacy of the compound, particularly the optimal dosage for anti-aging use. In the following slide we are trying to share with you the best way to do testing on the substances that are designed for anti-aging use.
CRO Company for Mode of Action & Efficacy Test for Drugs | InvivoBiosystemsWenlan Hu
Compound testing takes shares of a huge part of the drug development and health-related compound market. In order to find a CRO that is both friendly for budget saving and efficient at the same time is not easy. IVB uses a three staged compound assessment which includes RNAseq, whole transcriptome analysis, and other techniques to help our clients better understand the mode of action and efficacy of a particular compound.
Low cost nutraceutical hypothesis testingWenlan Hu
The US nutraceutical market is fast growing with increasingly demands on fast and economic nutraceutical testing labs. In order to succeed in a fast growing market, we need to review the market trends as well as the advantages of different model organisms in hypothesis testing.
The compound characterization market is growing increasingly profitable and competitive at the same time. In order to develop a new compound product, the testing step is indispensable. Unlike drug discovery, compound testing is not as restrictive, but understanding the main workflow is still necessary to excel in the market. In order to help you improve both the efficiency and safety of compound testing, we developed the protocol to assist you in your findings.
Alternative animal model for compound characterizationWenlan Hu
To pick a model is not easy thing to do, especially when nutraceutical market needs have to be met. Such market requires low budget, fast turn-around rate, and high-quality data at the same time. Traditional models such as mice and cell cultures usually only meet one need at one time. IVB uses C.elegans and zebrafish which lies in the middle of the model spectrum in terms of the three needs to perfectly accommodate all of them at the same time.
How to model longevity and health effect in 3 monthsWenlan Hu
Healthspan analysis is a huge part of longevity study, which is heavily looked at by many aging labs in recent years. The older we grow, our health will be affected accordingly, and this influence what type of compound we use. To better picture what effects compounds brings to us and to extend lifespan as a goal. A three stage compound assessment is developed by IVB to solve this question.
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
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Evolving Trends in mAb Production ProcessesKBI Biopharma
Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are
influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now
routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing havearisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non-chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes.
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
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.
Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...MilliporeSigma
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
-Potential risks associated with different areas of biotech processes
-What can be done to minimize adventitious virus risk in those areas.
The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
Oral presentation at ESACT 2015 (Barcelona) - Identification of process param...Albert Paul
Monoclonal antibodies (mAbs) are successful biotherapeutics in the treatment of various diseases. During manufacturing of mAbs higher molecular weight (HMW) aggregates can be formed during upstream (USP) and downstream (DSP) processing, which negatively influence product yields, reduce the therapeutic efficacy of the mAbs and trigger immunogenic responses upon administration. Reducing the level of aggregates during USP could improve the production of biopharmaceuticals and reduce the burden on expensive DSP removal of the HMW species. However, the lack of analytical tools to detect mAb aggregates in USP restricts understanding the origin of the aggregates and identifying cell culture conditions influencing product quality to reduce the level of mAb aggregates. We present a high-throughput compatible method which allows quantification of mAb aggregate formation directly in cell culture samples of Chinese hamster ovary (CHO) cells replacing falsifying, laborious and time-consuming chromatographic methods. Using this new methodology, we have screened for different culture conditions effecting mAb aggregate formation in a non-producing and a mAb producing CHO cell line. Finally, we have identified important process parameters to influencing protein aggregation in mammalian cell culture. Hence, our work demonstrates that the formation of mAb aggregates can be assessed directly in mammalian cell culture and product quality can be controlled by the selection of certain cell culture process parameters.
Managing Raw Material Variability Over the Life-cycle of a MoleculeKBI Biopharma
Managing Raw Material Variability Over The Life-Cycle Of A Molecule, Sigma S. Mostafa, Ph.D.Director, Process Development, Upstream KBI Biopharma, Inc.
Session : Selection of Source Materials (Biological products)
Scientists develop a new sars co v-2 vaccine with the successful experience o...DoriaFang
A multidisciplinary research team brought a new candidate SARS-CoV-2 vaccine. This vaccine draws on the successful experience of the hepatitis B vaccine platform, uses yeast to express the receptor binding domain (RBD) protein of the new coronavirus, and is supplemented with a new adjuvant to promote the immune response.
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
Borami Seo is Policy Manager at Korea Animal Rights Advocates.
She has been working on raising public awareness of the problems surrounding animal testing and animals used for human entertainment.
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.
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...Merck Life Sciences
Access the interactive recording: https://bit.ly/2xB2eRs
Abstract:
Vaccine and other biologic developers have long relied on traditional, growth-based methods for the detection of adventitious agents in a biosafety testing package. However, at a time where speed is of the essence, relying on testing methods that take many weeks is a real concern. Fortunately, alternative rapid detection methods can shorten timelines significantly — especially for Phase I testing. Here we will take you through these rapid alternatives and outline a testing strategy that can bring your therapy to the clinic faster.
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.
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.
Creative Bioarray offers a comprehensive selection of binding and functional GPCR assays to meet the GPCR drug discovery research needs of both chemists and biologists.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Evolving Trends in mAb Production ProcessesKBI Biopharma
Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are
influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now
routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing havearisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non-chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes.
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
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.
Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...MilliporeSigma
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
-Potential risks associated with different areas of biotech processes
-What can be done to minimize adventitious virus risk in those areas.
The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
Oral presentation at ESACT 2015 (Barcelona) - Identification of process param...Albert Paul
Monoclonal antibodies (mAbs) are successful biotherapeutics in the treatment of various diseases. During manufacturing of mAbs higher molecular weight (HMW) aggregates can be formed during upstream (USP) and downstream (DSP) processing, which negatively influence product yields, reduce the therapeutic efficacy of the mAbs and trigger immunogenic responses upon administration. Reducing the level of aggregates during USP could improve the production of biopharmaceuticals and reduce the burden on expensive DSP removal of the HMW species. However, the lack of analytical tools to detect mAb aggregates in USP restricts understanding the origin of the aggregates and identifying cell culture conditions influencing product quality to reduce the level of mAb aggregates. We present a high-throughput compatible method which allows quantification of mAb aggregate formation directly in cell culture samples of Chinese hamster ovary (CHO) cells replacing falsifying, laborious and time-consuming chromatographic methods. Using this new methodology, we have screened for different culture conditions effecting mAb aggregate formation in a non-producing and a mAb producing CHO cell line. Finally, we have identified important process parameters to influencing protein aggregation in mammalian cell culture. Hence, our work demonstrates that the formation of mAb aggregates can be assessed directly in mammalian cell culture and product quality can be controlled by the selection of certain cell culture process parameters.
Managing Raw Material Variability Over the Life-cycle of a MoleculeKBI Biopharma
Managing Raw Material Variability Over The Life-Cycle Of A Molecule, Sigma S. Mostafa, Ph.D.Director, Process Development, Upstream KBI Biopharma, Inc.
Session : Selection of Source Materials (Biological products)
Scientists develop a new sars co v-2 vaccine with the successful experience o...DoriaFang
A multidisciplinary research team brought a new candidate SARS-CoV-2 vaccine. This vaccine draws on the successful experience of the hepatitis B vaccine platform, uses yeast to express the receptor binding domain (RBD) protein of the new coronavirus, and is supplemented with a new adjuvant to promote the immune response.
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
Borami Seo is Policy Manager at Korea Animal Rights Advocates.
She has been working on raising public awareness of the problems surrounding animal testing and animals used for human entertainment.
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.
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...Merck Life Sciences
Access the interactive recording: https://bit.ly/2xB2eRs
Abstract:
Vaccine and other biologic developers have long relied on traditional, growth-based methods for the detection of adventitious agents in a biosafety testing package. However, at a time where speed is of the essence, relying on testing methods that take many weeks is a real concern. Fortunately, alternative rapid detection methods can shorten timelines significantly — especially for Phase I testing. Here we will take you through these rapid alternatives and outline a testing strategy that can bring your therapy to the clinic faster.
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.
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.
Creative Bioarray offers a comprehensive selection of binding and functional GPCR assays to meet the GPCR drug discovery research needs of both chemists and biologists.
EU REACH regulation changed the way to do chemical risk assessment. All chemicals marketed or manufactured in the EU must have its own dossier. Non standard methods including alternatives to animal testing are accepted.
Half Italian, half English
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
We have 13 research and development projects within:
• Research
• Oncology
• Respiratory, Inflammation and Autoimmunity
• Cardiovascular and Metabolic Disease
• Antibody Discovery and Protein Engineering
• Pathology
• Biopharmaceutical Development
• Cell Culture and Fermentation Sciences
• Formulation Sciences
• Analytical Biotechnology Science
Case Study: Peptides-based Plant Protection Product (harpin proteins*) by Ros...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
PEGS Europe Protein & Antibody Engineering Summit 2014 AgendaNicole Proulx
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
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•70+ scientific posters
•40+ sponsors & exhibitors
•Dedicated networking opportunities
•Exclusive exhibit & poster hours
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Process chemistry AS PER PCI SYLLABUS FOR M.PHARMShikha Popali
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The EPA CompTox Chemistry Dashboard provides access to data associated with ~760,000 chemical substances. The available data includes experimental and predicted physicochemical properties, environmental fate and transport data, in vivo and in silico toxicity data, in vitro bioassay data, exposure data and a variety of other types of information. The data are under continuous expansion and curation and the experimental data have been used to develop QSAR and QSPR models. A number of these models are available via a web interface so that users can submit a chemical structure and predict properties in real time. The dashboard also provides access to pre-compiled chemical lists and categories, including pesticides, and chemicals detected in the environment via non-targeted mass spectrometry analysis. The data are searchable using chemical identifiers (systematic names, trade names, CAS Registry Numbers), by structure, mass and formula. Batch searches allow for data associated with thousands of chemicals to be obtained in a few seconds, with just a few button clicks, and downloaded to the desktop. This presentation will provide an overview of the Dashboard and its applications to accessing source data associated with agriculturally related chemicals. This abstract does not necessarily represent the views or policies of the U.S. Environmental Protection Agency.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
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Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
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Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
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Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
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2. Mode of Action of
Compounds
Different compounds behave in
distinguished manner when tested. A
important aspect of compound
development is to understand the
mode of action of compounds. In order
to achieve this goal, IVB use RNAseq
and whole transcriptome analysis to
assist the findings. Based on the
findings, a well-round understanding of
a compound can be generated, which
assists the research findings in a
efficient and timely way.
4. InVivo Biosystems
4
InVivo Biosystems
is the market leader for early in-vivo testing using small animal models
to gain a better understanding of
the efficacy, mode of action, toxicity and potential targets of novel compounds.
Right Model. Right Test. Right Insights.
5. In-Vivo Testing: Obtain the Data You Need
5
The Nematode Caenorhabditis elegans The Zebrafish Danio rerio
COMPOUND TESTING TOXICITY ANALYSIS LIFESPAN HEALTHSPAN AGING STUDIES
Research Idea
Experimental Hypothesis
Project / Pipeline Goal
YOUR:
Complete Data Package
Fully Analyzed Results
Data-Backed Conclusions
YOUR:
InVivo Biosystems:
IN-VIVO
WHOLE-ORGANISM TESTING
6. InVivo Biosystems: Your On-Call Lab
6
Nutraceutical
Biopharma
Biotech
Pharmaceutical
COMPANY NEED
PROJECT SCOPE
TACTICAL
Select Experiments
or Models
STRATEGIC
Early-Mid
Project Phases
MAXIMAL
Full Project
Completion
7. Nutraceuticals + Healthy Aging
7
Nutraceutical
Biopharma
Biotech
Pharmaceutical
COMPANY NEED
PROJECT SCOPE
TACTICAL
Select Experiments
or Models
STRATEGIC
Early-Mid
Project Phases
MAXIMAL
Full Project
Completion
“Nutraceuticals may be used to
improve health, delay the aging process, prevent chronic
diseases, increase life expectancy, or support the
structure
or function of the body.”2
US nutraceutical market expected to reach
> $138 billion USD by 2027.3
Global nutraceutical market expected to
reach > $302 billion USD by 2022.4
Nutraceutical
8. Nutraceutical Market Drivers and Pain Points
CHALLENGES
DRIVERS RESTRAINTS
Strong Consumer Interest:
- anti-aging, general
- longevity and health
- skin care
- heart disease
- aging-related disease
Resources and Time Cost:
- high cost of raw material production
- limited supply of quality manufacturing materials
- long development pipeline increases production cost
- lengthy lab-to-market timeline if animal testing involved
Increasing Competition and Awareness:
- growing competition as new players continuously enter market
- increasing awareness among consumer base demands validation of claims
- results must be backed by scientific evidence of efficacy AND safety
8
10. Common Model Systems, Known Pitfalls
HTS of 1000’s of compounds
Fast data turnaround
X No organ-system
complexity
X No whole-organism effects
No HT possibilities X
Long timelines X
Full organ system complexity
Human-relevant dosages
Regulation
Resources / Cost
Experimental Timeline
Model Complexity
Cell Culture Mice
Relevance to Human
10
11. The InVivo Biosystems Approach
HIGH QUALITY DATA – FAST TURNAROUND – LOW COST
MEDIUM THROUGHPUT – LOW REGULATION
model systems capable of providing the detailed answers necessary to pursue your research aims
Regulation
Resources / Cost
Experimental Timeline
Model Complexity
Cell Culture MiceFishWorms
Relevance to Human
11
12. EARLY
go/no-go decision making
FAST
experiment turn-around
ECONOMICAL
pipeline
Nutraceutical Market Need: IVB Delivers
12
We focus on
proof-of-principle experiments
that provide the preliminary data necessary to quickly and confidently
make go/no-go decisions
during early-stage investigations.
13. The IVB Process: Simple. Effective. Fast.
13
INTRODUCTION
Understand
Your Goal
DESIGN
Create A
Personalized Catalog
LOGISTICS
Finalize Your Project
Design
REPORT OUT
Maintain Clarity and
Transparency
[ 3 MONTHS ]
14. INTRODUCTION
Understand
Your Goal
DESIGN
Create A
Personalized Catalog
LOGISTICS
Finalize Your Project
Design
REPORT OUT
Maintain Clarity and
Transparency
[ 3 MONTHS ]
Your Data Package, Your Next Move
14
MARKETING MATERIALS
PRESS RELEASE
INVESTOR MEETINGS
FUNDING ROUNDS
GRANT PROPOSALS
PATENT
APPLICATIONS
DEVELOPMENT
PIPELINE
WHITE PAPERS
SCIENTIFIC
PUBLICATIONS
15. InVivo Biosystems Platform Solutions
15
The Nematode Caenorhabditis elegans
LIFESPAN +
HEALTHSPAN
The Zebrafish Danio rerio
In Vivo TOXICITY
TESTING
CUSTOM DESIGN
SOLUTIONS
16. The Longevity Platform – 3 Stages
16
LIFESPAN +
HEALTHSPAN
QUESTION
What are the effects of a compound on
lifespan, healthspan, and transcriptional
changes related to aging?
What is the mechanism of action?
STAGE I
Dosage
Optimization
STAGE II
Data
Collection
STAGE III
Molecular
Analysis
17. IVB Longevity Compound Assessment: Stage I
17
Stage I: DOSAGE OPTIMIZATION
- Rule out possible toxicity.
- Test for most suitable downstream dosage.
- Determine… a) whether full longevity experiment suitable;
b) if so, at what compound dosage/under what conditions.
[Drug]
GFP
constitutive
RFP
induced
EC50
18. IVB Longevity Compound Assessment: Stage I
18
Fig. 1.1:
EC50 determined for
compound Lu0128.
Fig. 1.2:
Viability, growth, and
development toxicity
analysis for compound
Lu0128.
Xenobiotic Stress Oxidative Stress
C. elegans Length C. elegans Development
19. 19
IVB Longevity Compound Assessment: Stage II
Stage II: DATA COLLECTION
- Specific metrics as pertinent to experiment.
- Monitor animals for survival, morphology, specific movement patterns, etc.
- Generate a full, high-resolution and multi-dimensional data set.
20. 20
IVB Longevity Compound Assessment: Stage II
Stage II: DATA COLLECTION
- Specific metrics as pertinent to experiment.
- Monitor animals for survival, morphology, specific movement patterns, etc.
- Generate a full, high-resolution and multi-dimensional data set.
21. 21
IVB Longevity Compound Assessment: Stage II
Stage II: DATA COLLECTION
- Specific metrics as pertinent to experiment.
- Monitor animals for survival, morphology, specific movement patterns, etc.
- Generate a full, high-resolution and multi-dimensional data set.
N = 75
ΔT = 3
days
P = 0.15
N = 150
ΔT = 1
day
P =
0.014 N = 300
ΔT = 1
hour
P =
0.0000054
High Resolution Analysis
22. IVB Longevity Compound Assessment: Stage II
22
Fig. 2.1:
Survival and hazard
rate curves from
lifespan assay.
Survival Rate Hazard Rate
Fig. 2.2:
(L) Morphological
features analyzed, and
(R) Principal
Component Analysis
(PCA) of multi-
dimensional data set.
Principal Component
Analysis
23. 23
IVB Longevity Compound Assessment: Stage III
Stage III: MOLECULAR ANALYSIS
- Perform whole transcriptome analysis (WTA).
- Delve into mechanism of action.
- Identify pathways and players responsible for observed effects.
Fig. 3.1:
Volcano plot depicting
gene expression
change in compound-
treated v. untreated Day
10 adult worms.
C.e. Day 10 Adults
24. 24
IVB Longevity Compound Assessment: Stage III
Longevity Pathway Analysis
Fig. 3.2:
Gene expression
analysis comparing
compound-treated v.
untreated Day 10 adult
worms, grouped by
pathway.
26. Case Use: Compound Analysis for ENCo*
26
*Company name and other identifiers have been altered to maintain confidentiality.
Company: European Nutraceutical Company (ENCo)
A small European-based nutraceutical company focused on developing…
- natural extracts and compounds that have the ability to promote healthy aging;
- food supplement formulations for the improvement of human vitality and longevity.
Company’s Need:Move very RAPIDLY from HYPOTHESIS to early PROOF-OF-CONCEPT
27. Case Use: Compound Analysis for ENCo*
27
ENCo:
“While mammalian models are currently the gold standard for drug
development,
the enforced 3Rs and animal welfare guidelines have required us to re-evaluate our
development pipeline to include early stage in-vivo hypothesis testing.
Understanding the biology of our compounds necessitates the use of an
alternative model prior to going to more regulated, more resource and time-intensive
models.”
3Rs of Animal Use in Research
REPLACE REDUCE REFINE
28. Case Use: Compound Analysis for ENCo*
28
ENCo’s Hypothesis / Question:
A. Do ENCo’s selected compounds (Compound A and Compound B) have any whole-organism effect on animal
longevity?
B. If so, what is the mechanism driving Compound A and Compound B efficacy?
C. How does ENCo characterize Compound A and Compound B to advance progress towards clinical applications?
29. Case Use: Compound Analysis for ENCo*
29
ENCo’s Goal:
Identify a single compound or synergistic compound mixture with the most positive and reproducible effect on
longevity.
ENCO’s Framework:
- Data that is directly relevant to human health and the whole-body system.
- Short 6-month timeline to encompass experimental design, preparation, execution and analysis of results.
- Data to be formatted and available for use in patent application(s).
ENCO’s Requirements:
- Seeking whole-organism, in-vivo data
rather in-vitro experiments.
- Seeking fast, reliable and biologically
relevant data in a whole-animal model.
- Avoiding associated cost, timeline and
regulatory paperwork of rodent models.
30. Case Use: Compound Analysis for ENCo*
30
ENCo’s Challenges:
- In-vitro data alone not suitable or sufficient for downstream patent application needs.
- Rodent models are gold standard for in-vivo work, but too time consuming and too costly at this stage.
The In-Vivo Biosystems Solution
Using the small animal model C. elegans,
we proposed and executed a specific set of experiments designed by our expert team to address ENCo’s specific
research goals, and to provide rapid and reliable data based upon the company’s short-term priorities and long-term
aims.
Population
Locomotion
Individual
Locomotion
Molecular
Phenotyping
Lifespan
Assessment
Healthspan
Assessment
31. Case Use: Compound Analysis for ENCo*
31
Kaplan-Meier survival curve depicting results of compound impact on C. elegans lifespan.
ENCo – Sample Data Acquired:
Lifespan
Assessment
Lifespan assay tracking individual worm lifespan within a population;
percent of worm population surviving (y-axis) versus time in days (x-axis).
32. Case Use: Compound Analysis for ENCo*
32
Electropharyngeogram (EPG) results depicting contraction of the pharyngeal muscle in C. elegans adult worms.
ENCo – Sample Data Acquired:
Individual
Locomotion
Frequency of contraction of the pharyngeal muscle (left) and
amplitude of contraction of the pharyngeal muscle (proxy for
strength of muscle contraction, right).
33. Case Use: Compound Analysis for ENCo*
33
Achieved Outcome:
Using the data that we generated, ENCo was able to…
- obtain conclusive and reproducible data within their allotted timeframe;
- apply for multiple patents in a timely manner;
- ultimately moved forward with further development of lead compounds revealed during the project.
Animal
Model
Conditions
Tested
Assays
Utilized
Figures/Table
s
Generated
Project
Time
Project
Cost
Patent
Applications
1 15 $45,500 12 4 13 1 +
ENCo ANALYSIS: BY THE NUMBERS
C.
elegans
weeks USD
34. INTRODUCTION
Understand
Your Goal
DESIGN
Create A
Personalized Catalog
LOGISTICS
Finalize Your Project
Design
REPORT OUT
Maintain Clarity and
Transparency
Case Use: Compound Analysis for ENCo*
34
MARKETING MATERIALS
PRESS RELEASE
INVESTOR MEETINGS
FUNDING ROUNDS
GRANT PROPOSALS
PATENT
APPLICATIONS
DEVELOPMENT
PIPELINE
WHITE PAPERS
SCIENTIFIC
PUBLICATIONS
35. InVivo Biosystems
35
In-Vivo Biosystems
is the market leader for early in-vivo testing using small animal models
to gain a better understanding of
the efficacy, mode of action, toxicity and potential targets of novel compounds.
Right Model. Right Test. Right Insights.