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CAR-T療法

個別化医療の実現に向けて

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概要

最先端の治療には最先端のソリューションを

キメラ抗原受容体T細胞（CAR-T）療法は、生物学的製剤開発の新しい分野です。この治療法は、様々な形態のがんを標的とし、「生きた治療法」として作用します。患者自身のTリンパ球細胞を利用する個別化医療のひとつです。

CARsは人工的な受容体タンパク質で、ほとんどが天然のサブドメインで構成されています。この治療法を研究している科学者は、実験室でのデータ管理に多くの課題を抱えています。

サイトカイン放出症候群のような副作用を回避するため、タンパク質を正確に定義し、その完全な化学記述を捉えることは、知的財産（IP）保護のために非常に重要です。また、サブドメインと関連するエンティティ間の関係を追跡することも不可欠です。このような複雑なワークフローには、柔軟性があり標準化されたソリューションが必要です。また、科学者は十分な情報に基づいた迅速な意思決定を行うために、すべてのデータをリアルタイムで確認する必要があります。

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CAR-T療法

課題

データの記録

CAR-Tの研究では、実験の計画と実行の繰り返しが必要です。研究が進むにつれて、実験はアドホックなものから標準化されたワークフローへと移行します。

データの追跡

CAR-Tの研究では、さまざまな前駆体タンパク質から多くの候補分子が生まれます。CARsとそのサブドメイン間の関係を追跡することは重要で、その情報はいつでも入手できるようにしておく必要があります。

データの保護

CAR-Tの研究では、抗原結合と細胞応答の適切な組み合わせを持つ新規のCARsを設計し、その貴重な研究データを保護する必要があります。

特徴

ドットマティクスのソリューション

icon 実験データの記録

ドットマティクスのソリューションは、幅広い分野の実験データが記録でき、シンプルな実験だけでなく、複雑なワークフローもサポートします。ドットマティクスの電子実験ノート（ELN）であるStudies Notebookは、CARsとその構成サブドメインの開発をサポートします。

icon 候補分子の登録と関係性の追跡

ドットマティクスのソリューションは、CAR-Tの受容体を完全に定義し、構成するサブドメインの履歴を追跡することができます。また、活性と安全性を最適化するために変更を加えながら、全長タンパク質間の関係を追跡することもできます。エンティティと関係性は、Bioregisterでいつでも確認することができ、知的財産（IP）が完全に保護されます。

icon すべてのデータにいつでもアクセス

正しい意思決定を行うためには、データの全体像を見ることが重要です。Browser は、必要な情報を必要な形で表示させることができます。すべてのデータにいつでもアクセスできるため、十分な情報に基づいた迅速な意思決定が可能です。インタラクティブな表やチャートを使って、次の受容体候補を設計するための「もしも」の質問をすることもできます。
PRODUCTS

This solution consists of

iconDotmatics Bioregister

Dotmatics’ Bioregister is a web-based application for registering sequence-based, chemically-modified and structureless biological entities, allowing biologics discovery organizations to ensure entity uniqueness and protect their intellectual property. Bioregister supports management of a broad set of biologics entities, including DNA, RNA, peptides and proteins, antibodies, conjugates, non-natural peptides and nucleotides,  plasmids, cell lines and user-defined entities. It also enables users to record batches and samples for these entities, purification and expression information, and other protein production data.

  • Records and manages biologic entities, including chemically-modified sequences and sequence-less entities, and associated attribute data and lineages
  • Generates chemical representation (where possible) of natural and non-natural entities
  • Determines the uniqueness of entities and assigns registration numbers, including using full chemical-based uniqueness where possible
  • Manages data associated with entity production, such as protein expression, purification and characterization
  • Records batches and samples of protein produced for the entities, with full relationship tracking
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iconDotmatics Studies Notebook

Dotmatics Studies Notebook is an Electronic Laboratory Notebook (ELN) with flexible templating to capture, store and search experiments from all scientific disciplines.

  • Dotmatics Studies Notebook allows scientists to capture and store their experiments in a form that is easily searchable by all team members. It allows organizations to secure and audit IP and define signing workflows
  • Flexible protocols (implemented as templates) allow the single ELN to accommodate highly structured experiments such as synthetic chemistry and protein purifications, as well as more ad hoc experiment types often useful for target identification and discovery biology experiments. Ad hoc experiments are also often used to support a transition from paper based notebooks
  • Dotmatics Studies Notebook allows for collaboration on experiments by multiple scientists within or between organizations
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iconDotmatics Browser

Dotmatics Browser provides a comprehensive view of project data

  • With Browser, scientists can search, review and interpret information about their CAR candidates
  • Data views are configurable and interactive, supporting both individual investigation and collaboration
  • Scientists have all the information necessary to make well-informed decisions, and drive projects forward.
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iconDotmatics Studies

Dotmatics Studies is a highly flexible, innovative screening data management solution to capture and analyze all types of screening experiments from high content (HCS) and high throughput (HTS) to dose-response and DMPK studies.

  • Defines analysis protocols for plate and non-plate based assays
  • Provides out-of-the-box and custom assay protocols, curve fit calculations, plate readers, and plate layouts captured and stored for re-use
  • Supports very high data volume assays
  • Defines business rules for very automated classification of results
  • Manual or automated processing allows screening scientists to apply the screening protocols to process raw instrument and validate the results, or experiment creation and processing to be driven via an automation layer.
  • Once completed and validated, screening results are immediately available via Browser to the project team
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iconDotmatics Vortex

Dotmatics Vortex is an interactive data visualization and analysis solution for scientific decision support. Building on and extending the spreadsheet paradigm, it provides the data manipulation, statistical analysis and sophisticated plotting capabilities required to explore and understand any complexity and size of data. Vortex is also scientifically aware providing native cheminformatics and bioinformatics analysis and visualizations.

  • Allows users to understand, refine and select from large and/or complex data sets
  • Allows teams to collaborate on scientific analysis through shareable workspaces and reusable templates
  • Understands numeric, textual, image, chemical structure and biologic sequence data
  • Generates high performance, interactive visualizations, including charts and tables
  • Handles very large datasets – e.g. tables of millions of compounds by thousands of descriptors or cells containing whole genome sequences
  • Has inbuilt data mining, statistical, cheminformatics and bioinformatics analysis functions
  • Loads data from many types of file or when used in conjunction with Browser, directly from databases
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iconPlatform

The Dotmatics Platform is the common framework that supports the Dotmatics web-based scientific applications and allows them to work together to provide users seamless end-to-end workflows. The Platform supports managed deployments in the Cloud or self-supported deployments on premise. An open architecture enables workflows to include third-party software integration. When used together with Dotmatics Browser the Platform allows federated data access across corporate and external research data.The Dotmatics Platform is completely unified – it provides common data models, code and architecture to support business workflows that span the capabilities of the individual applications. This is important for enterprise enablement of research organizations, providing ease of maintenance and development. It gives the lowest possible total cost of ownership compared to platforms that support their applications with less tightly integrated collections of multiple technologies and/or architectures with multiple development histories.

  • Provides the framework that supports all Dotmatics web-based scientific applications and allows them to work together to provide seamless workflows.
  • Portal for administrators to manage users and groups, applications and configurations
  • Provides APIs for automation and integration with 3rd party software
  • When used in conjunction with Dotmatics Browser provide access to data from across an organization and externally

iconDotmatics Inventory

Dotmatics Inventory is a fully searchable sample and materials inventory that tracks chemicals, biologics, instruments and associated data across a hierarchy of locations and manages the dispensing and plating workflows, as samples are moved through an R&D process.

  • Defines a hierarchy of storage locations for an organization
  • Track samples in containers such as bottles and plates in those storage locations
  • Manages research materials, reagents and assets
  • Manages the aliquoting and dispensing workflows to distribute samples for testing
  • Maintains a full audit trail
  • Allows for searching and reporting on inventory information alongside other corporate data

iconDotmatics Cascade

Dotmatics Cascade manages the requesting and assignment of laboratory tasks, and tracking the progression of samples, across multiple teams within an organization or across a collaborating network.

  • Dotmatics Cascade allows organizations to define available services, such as assay execution or analysis and the associated scientific team
  • Scientists create requests for services and submit compounds Service managers manage, group and assign requests for execution
  • Service team scientists accept requests, create and autopopulate experiments to execute them
  • Teams can see request status and monitor compound or sample progression

iconDotmatics Cloud

Mobile technology offers a unique opportunity to collaborate, access data and make decisions on the go, increasing throughput and reducing time consumed by review processes. The Dotmatics Platform on the cloud allows the integration of multiple, diverse systems and data sources. Organizations can now securely access all of the Dotmatics solutions, using a web browser, on their own dedicated instance running in the cloud. This provides users with an all-encompassing view of relevant information, enabling better informed science and business decisions.The Dotmatics Platform in the cloud is powered by Amazon Web Services™ (AWS). Data security is guaranteed when using the gold standard AWS infrastructure. Dotmatics’ solutions are installed in Amazon-controlled data centers around the world thus ensuring that data is housed at the user’s preferred location. The Dotmatics Platform provides a single point of access to all science data and functions across multidisciplinary groups. The flexibility enables scientists, collaborators and partners to instantly interact with the same data via the cloud regardless of location and time zone, fulfilling the promise of real time research.

  • Each customer’s data is held in a separate dedicated instance
  • Access to your instance is controlled by two layers of firewall and user authentication
  • All traffic to/from the instance is HTTPS/SSL encrypted

At the heart of collaborative research

  • Dotmatics Cloud in combination with the Dotmatics Platform revolutionizes the way that collaborative research is done
  • Dotmatics’ flexible and comprehensive platform offers secure access to users per project
  • Not just simple file sharing, but true idea generating solutions
  • Internal and external R&D teams across the world can share data and generate new discussions leading to the creation of innovative ideas and IP

Protect and control your database with single tenancy

  • A separate instance of the Dotmatics Platform and its supporting infrastructure is available to each customer, which provides significant capability to easily configure the system to mirror the requirements of each team
  • For example, R&D teams can adapt features such as additions to individual modules to various internal databases and external partner databases

Secure access from users’ preferred device

  • Simply set up new collaborative projects with multiple teams and start sharing data promptly with no extra training required for users with computers or mobile devices
  • Data from collaborators can be accessed in real time by all members of a project, enabling around-the-clock global research
  • The Dotmatics Platform is hosted within the secure and private AWS infrastructure
  • Amazon’s servers are supported by ISO 27001 certification and have successfully passed multiple SAS70 Type II audits