Cimna Slide Show October 2009

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TcLand-Expression / CIMNA center for Immunomonitoring

CIMNA is an immunology service center that offers immune response analysis to support drug development. It provides expertise, state-of-the-art technologies, and quality services through specialized immunology testing including flow cytometry, ELISPOT, bead arrays, and transcriptomics. CIMNA has over 60 employees working in a 1300 square meter facility in Nantes, France, and is overseen by a scientific committee of experts in immunology and therapeutic areas.

Health & Medicine Technology

The unique immune
monitoring service
center for your drug
development

www.cimna.org

Immunomonitoring for drug development

 Immune response analysis:
a real added value to strengthen your pipeline

 Regulatory environment
New requirements of EMEA and FDA for a better understanding of:
• drug mechanisms of action
• scientific context
• initial drug dose evaluation

 Industrial environment
• Obtain necessary information for GO/NO GO decisions
• Strategic discovery of Biomarkers

www.cimna.org

CIMNA unique integrated Immunomonitoring center

 CIMNA is a niche service provider specialized in
immunology

 We offer an access to a high-quality one-stop shop:

 EXPERTISE (board of experts in Immunology)
 State of the Art Technologies
 QUALITY Services
 Project Management

www.cimna.org

CIMNA organisation

1300sqm of Laboratories, +60 employees, 1 location (Nantes, France)

www.cimna.org

Scientific Committee

 A high-level scientific committee ensuring best adequacy and
interpretation of information for the specific needs of our partners

 Chairman: Prof. Régis JOSIEN

 TECHNOLOGY EXPERTS
• Cytomics: Dr. Marie RIMBERT
• Transcriptomics : Dr. Rémi HOULGATTE
• Repertoire: Dr. Marina GUILLET
• Statistics: Dr. Nadine GODFROID

 EXPERTS BY THERAPEUTIC AREA
• Transplantation : Prof. Jean-Paul SOULILLOU
• Autoimmunity/inflammation: Prof. Mohamed HAMIDOU
• Oncology & Immunotherapy: Prof. Marc BONNEVILLE
• Neuroimmunology: Dr. David LAPLAUD
• Allergy: Prof. Antoine MAGNANT
www.cimna.org

Cytomic unit

 ELISPOT
• antigen-specific cytokine-secreting T cells (vaccin
development, autoimmunity, infectious disease, cancer,
transplantation) GBEA
• antigen-specific CTL
• antigen-specific antibody producing B cells
 POLYCHROMATIC FLOW CYTOMETRY
• immune cells (T, B, NK, DC, Mono.)
• T cell subsets (naive, effector, central memory, effector
memory)
• Counting of antigen-specific T cells with tetramers
• Intracellular cytokine staining to assess T cell function
 MULTIPLEX BEAD ARRAY ASSAYS
• Multiple cytokine/chemokine quantification (immune
response, inflammation, cytokine storm, etc..).
• Multiple auto-antibody titration
 ELISA
• Cytokine/chemokine dosage
• Immunoglobulin dosage
• Auto-antibody detection and titration
www.cimna.org

T cell repertoire & qPCR unit
 TcLandscape
• Transcriptomic approach to the analysis of T cell receptor
populations.
• Qualitative analysis of the TCR Vb Gene usage and CDR3 ISO
Length distribution combined with qPCR on TCR mRNA 17025
transcripts

 Indications:
• Immune response detection & characterization
• Targeting immune populations for functional analyses
• Improvements in understanding disease
• Screening drug candidates for their effect on T cell
mobilization
• Diversity analysis (Epitope spreading, Clonality testing)
• Potential beneficial activity in animal models

 T Cell mobilization signature

 qPCR unit
• Customized service using our real-time PCR platform (ABI
7900HT)
• ISO 17025 compliant
• Easy and rapid transfer of your protocol to ISO 17025 www.cimna.org

Transcriptomics Unit
 Microarrays services
 DNA Chip (Agilent, Affimetrix) ISO
9001
 miRNA expression
 SNP genotyping
 BioInformatics & biostatistics (21CFR part11)

Clinical operations Unit
 Methodology
 Regulations
 CO, Monitoring
 Data Management GCP
 Biostatistics
 Medical writing
 Web Randomization
www.cimna.org

The unique immune
monitoring service
center

www.cimna.org

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Watch the presentation of this webinar here: https://bit.ly/3ryE5ST Optimize your mesenchymal stem cell growth. Join our webinar to learn more about our GMP-compliant xeno free media formulation that supports high performance expansions and compatibility with scalable xeno free manufacturing conditions. Optimizing ex vivo cell expansion processes in preparation for clinical use is a critical step in cell therapy manufacturing. Given the curative and lifesaving impacts these therapies can have on patients, overcoming roadblocks with scalability and supply chain, using high quality raw materials are essential for therapeutic access. The GMP-compliant Stemline® XF MSC Medium and cocktail promotes expansion of human mesenchymal stromal/stem cells (hMSCs) to high densities while maintaining cell identity and quality. This product was designed for derivation and expansion of MSCs using xeno free conditions in planar and microcarrier-based culture platforms, easing the transfer between research, clinical, and manufacturing scale cultures. In this webinar, you will: • Explore the current landscape and future trends of cell culture media for adult mesenchymal stem cells • Discover ways to derive MSC's from Bone Marrow in Xeno Free conditions from static to microcarrier-based suspension culture platforms. • Learn how Stemline® XF MSC Media provides robust performance and reduces scalability roadblocks Presented by: Kathleen Ongena, Ph.D., Head of Customer Applications and Mark Ventresco, Cell Therapy Product Manager

Does your cell line have a secret? Avoid surprises with characterization

Merck Life Sciences

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FNP workshop presentation

anshusls

Genomics In Personal Care Product Development

Genemarkers

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Game Changers Cancer Immunotherapies: Checkpoint Inhibitors

iData Insights

This document provides an overview and analysis of checkpoint inhibitors for cancer immunotherapy. It discusses the PD-1/PD-L1 and CTLA-4 pathways that are targeted by these drugs. Case studies are presented on the checkpoint inhibitor drugs Opdivo, Keytruda, and Yervoy, examining their development timelines, clinical trial profiles, pricing, regulation, and life cycle management. The report also analyzes the efficacy and safety of these drugs in melanoma treatment and provides insights on the global melanoma market and market potential of Opdivo and Keytruda.

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Releasing Your AAV Therapy with Confidence: Regulatory Considerations and Key...

Merck Life Sciences

Watch the presentation of this webinar here: https://bit.ly/3icKkbZ Ensuring the safety and quality of your AAV vector is of the utmost importance. Join this webinar for a high-level overview of the regulatory requirements for AAV testing throughout the manufacturing process, as well as a more detailed look at rcAAV and infectious titer assays. Adeno-associated virus (AAV) vectors possess a number of advantages for use in human therapy including: high titer preparations, low immunogenicity, capacity to infect a wide range of cell types, and replication deficiency. Even with these advantages, there are biosafety concerns to consider when using AAV vectors. This webinar will discuss key regulatory considerations across the manufacturing process, from the helper/packaging plasmids through to lot release testing. We will highlight critical assays that are required and delve into specifics on replication competent AAV testing and infectious titer determination by TCID50. In this webinar, you will learn: • Critical biosafety considerations for AAV vectors based on the latest regulatory guidance • How replication competent AAV testing fits into your bulk and final release testing package • The benefits of routine and platform assays over custom assay development Presented by: Steven McDade, Senior Technical Specialist, Field Technology Management Alfonso Lavorgna, Ph.D., Operations Manager, Virology Services

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The cannabis plant and cannabis products are highly varied and complex matrices. In the absence of rigorous study this immature industry has decided to adopt methods commonly used in food testing to obtain information about the potential microbial hazards present. However DNA sequencing of both the cannabis microbiome and the conditions before and after culturing tell a tale of inaccurate methodology. Methods that are currently being employed are leading the cannabis industry astray while blinding them to the real hazards that could be present. This presentation will walk you through the data that shows this and the discoveries we've made along the way that will hopefully open discussions for a fresh new perspective on how to tackle microbiological contaminants in cannabis.

Emerging Viral Risks and Mitigation Strategies in Biologics Manufacturing

MilliporeSigma

This document discusses emerging viruses that pose risks as contaminants in raw materials used to manufacture vaccines and biological products. It outlines various risk mitigation strategies, including risk assessments of potential contaminating viruses to inform detection methods. Specific viruses that are addressed include porcine circovirus type 3, hepatitis E virus, Schmallenberg virus, Zika virus, and Borna disease virus. Next-generation sequencing is presented as an advantageous method for the holistic screening of raw materials to identify both known and novel viruses. Quality by design approaches are emphasized to continuously reassess risks from emerging viruses.

Rapid Methodologies for Biosafety Testing of Biologic Therapeutics

MilliporeSigma

Learn about existing and emerging methods to accelerate biosafety testing of biologic therapies. Speed to market for biologic therapeutics is ever more critical. However, the critical safety tests for these molecules, for example screening for adventitious agents such as viral contaminants, can be time consuming as well as challenging and laborious. Join us for this webinar as we explore how rapid methodologies are being used to not only accelerate this process, but also enhance quality by reducing testing complexity. Existing technologies as well as emerging trends will be discussed, along with the implications these may have on the regulatory landscape. In this webinar you will learn: ● Which existing and emerging technologies are having now, and will have in the future, an impact on biosaftey testing. ● The benefits as well as risks of employing rapid methods for biosafety screening. ● How the regulatory agencies are reacting to rapid testing methods as alternatives to existing methods.

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.

NGS for Infectious Disease Diagnostics: An Opportunity for Growth

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Infectious diseases are a major public health concern causing over 3.5 million deaths worldwide. Diagnosing patients as quickly and effectively as possible is crucial for managing disease outbreaks. Next-generation sequencing (NGS) provides unique capabilities to understand the genetic profile of infectious disease patients that no other technology can match. Whole-genome metagenomics allows clinicians to take a deeper dive into pathogens by generating big-data about their characteristics. This data can be rapidly analyzed using complex bioinformatics software algorithms to achieve clinical-grade diagnostic accuracy. In a healthcare system shifting towards personalized medicine, NGS can provide clinicians the tools that they need to prescribe individualized treatments to save patients who were previously untreatable. The result is improved quality of care, better treatment regimes, and cost-saving healthcare.

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Holistic Approaches to Virus Risk Mitigation

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Presented at INTERPHEX on March 21-23, 2017. Regulatory guidelines have shaped industry best practices around adventitious virus contamination risk mitigation in terms of patient safety. A recent survey indicated that the cost to remediate a virus contamination can run into millions of dollars, not including commercial impact. Today, the industry is taking a closer look at minimizing the business risk associated with viral contaminations and is taking a more holistic view of risk mitigation. This approach includes virus prevention and detection in addition to removal. From cell culture seed train to final fill vial, the discussion will describe the potential risks associated with different areas of biotech processes and 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, testing and regulatory considerations.

Biosafety in Gene Therapy: Applying the latest regulatory guidance for RCL te...

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Watch the presentation of this webinar here: https://bit.ly/33WUiqE Ensuring the safety and quality of your lentiviral vector is of the utmost importance. Attend this webinar to learn about testing strategies to monitor replication competent lentivirus. You will also hear about recent changes in regulatory guidance with regards to sample types and volumes tested. The use of lentivirus vectors to produce groundbreaking gene therapies is on the rise. Ensuring the biosafety and quality of these vectors is achieved through a multi-tiered testing approach. For lentivirus-based therapies, generation of replication competent particles is a potential risk. While improvements in design and manufacturing have decreased the probability of producing replication competent viruses, regulatory agencies provide guidelines to test for their presence at multiple stages in production. This webinar reviews the strategies for monitoring replication competent lentiviruses. We describe current methods and address: Sample types, testing volumes, and expected results. In this webinar, you will learn about: • The latest FDA regulatory guidelines on replication competent lentivirus (RCL) testing • Methods used to monitor RCL • Considerations on sample type and volume requirements

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TcLand-Expression / CIMNA center for Immunomonitoring

Axt microarrays

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This document discusses clinical and consumer applications of microarrays and genotyping technologies. It provides an overview of genotyping and different technologies like PCR microarrays and SNP microarrays. It describes how microarrays are still useful despite the rise of sequencing due to their low cost, high throughput, and ability to test millions of markers. The document outlines several applications of microarrays like direct-to-consumer testing, pharmacogenetics, and clinical sequencing. It also discusses challenges and trends in these areas like global initiatives to increase genomic data sharing.

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