ABOUT US

From concept to design and development, clinical trials, governance, manufacturing and after sales services, our solutions enable you to address your challenges and improve your competitiveness

BioPharma companies need a scientific management environment that can help discover, connect and bring to market biological, chemical and pharmaceutical innovations to improve the way we live.

The Dassault Systèmes 3DEXPERIENCE® platform is focused on end-to-end integration of the diversity of science, experimental processes and information requirements across research, development, QA/QC and manufacturing. Capabilities over the areas of Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics.

Dassault Systèmes has a deep understanding of the challenges facing pharmaceutical and biotech companies and is committed to helping you advance the pace of discovery of new drugs and medicines. The BioPharma solution areas from Dassault Systèmes include:

Research & Development
Designed to Cure enables therapeutic delivery, the prediction of critical design and manufacturability characteristics and delivers an integrated, comprehensive and rational drug development approach through virtual design, collaboration and knowledge driven innovation.
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Unified Laboratory Operations Management
ONE Lab integrates people, resources, processes, data and interfaces for improved efficiency and collaboration, reducing redundant work and providing faster insight to get to your desired outcome.
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Manufacturing
Made to Cure for BioPharma is the only comprehensive industry solution using performance data from process development and production runs to aggregate, contextualize and analyze quality and process data in a validated environment reducing time to market and manufacturing variability.
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Quality and Compliance
License to Cure for BioPharma provides digital continuity for organizations to manage the complexity of an ever increasing number of medicinal products with a single version of the truth based on IDMP standards and enables change impact analysis, informed decision making and full IP reuse to deliver quality best practices shifting the paradigm of regulatory as a constraint to regulatory as an asset.
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FEATURED PRODUCTS

Dassault Systemes offers the SIMULIA Living Heart Human Model designed as a high-fidelity Multiphysics model of a healthy, 4-chamber adult human heart and proximal vasculature. The model features a dynamic response governed by realistic electrical, structural, and fluid (blood) flow physics. With this heart model, medical professionals, researchers, and device manufacturers have the ability to conduct experiments in a highly realistic 3D environment.

Organizations need to manage chemicals safely from receipt to disposal along the entire lab-to-plant value chain, ensuring Environmental Health and Safety (EH&S) compliance across the enterprise.

Today’s science-based companies are very aware of the importance of Quality in conducting a successful business and sustaining competitive advantage. Therefore, many enterprises have a Quality Strategy in place.

Many research organizations are increasing their efforts in biotherapeutic discovery, development and manufacturing. The BIOVIA Biologics Solution is a suite of capabilities supported by a common platform designed to help overcome barriers to innovation and process efficiency for the discovery and optimization of biotherapeutic candidates and the optimization of the overall workflow that includes development, manufacturing and compliance processes.

The BIOIVIA Signal Monitoring Dashboard (SMD) solution is a purpose-built validation-ready environment that satisfies requirements for Continued Process Verification (CPV), process robustness and process performance visibility needs across local operations and global manufacturing networks that include Contract Manufacturing Organizations (CMO’s). Automated alerts driven by a sophisticated and flexible rules engine provide review-by-exception for efficient Process and Product Monitoring (PPM) that includes direct connections to process and quality databases as well as CFR 21 Part 11-compliant capture of paper based data.

BIOVIA’s Process Production Operations solution, BIOVIA Discoverant, is a validation-ready solution for process and quality data access, aggregation, contextualization, analysis and reporting. BIOVIA Discoverant empowers production operations in process industries like life science or specialty chemicals to shorten time to market and maximize profitability by enabling understanding of critical process drivers that drive desired business results, monitoring variability for preemptive action and leveraging opportunities to maximize sustainability.

Biologics manufacturers are challenged today with reducing variability and costs, as well as speeding time to market by collaborating across growing manufacturing networks with external and internal partners spread across the globe. As they strive to develop and improve process performance and quality to meet business, regulatory and patient needs, effective utilization of their process and quality data is critical to success. The Biologics Made Right First Time Industry Process Exerience enables understanding of critical bioprocess drivers, monitoring variability for preemptive action and leveraging opportunities to maximize sustainability and maximize profitability and shorten time to market.

BIOVIA Laboratory Information Management System is purpose-built to manage 21st-century product and process informatics requirements with a specific focus on scale-up, manufacturing and compliance that eliminates the complexities, excessive customization and lengthy associated validation requirements inherent with legacy BIOVIA LIMS. The result is streamlined deployment, substantially lower total cost of ownership and rapid time to value.

CONTACT INFORMATION

Dassault Systèmes Americas

5005 Wateridge Vista Drive

San Diego, CA 92121

Phone: 732-841-8497

Contact: Brendan Spiegel

ARTICLES

CASE STUDIES

  • A biopharma company’s experimental records, recipes and scientific results were stored in multiple Excel files, scanned PDF documents and siloed lab solutions, many of which did not use the same conventions from lab to lab or scientist to scientist. disconnects were leading to additional lab work at late stages, workflow inefficiencies, long review times, delayed decisions, excessive effort and wasted material. They needed to implement a common solution across all CMC labs and for all therapeutic modalities—both small molecules and biologics.

  • Inefficient lab workflows and poor visibility across research data was threatening to jeopardize clinical programs, from discovery to registration and beyond for a biotechnology company. They needed to replace their legacy, paper-based processes with an entirely digitalized lab environment that supported the innovation lifecycle from target identification to compound discovery and process development.

  • A biopharma company that supports drug discovery activities had been using a legacy plug-in to Microsoft® Excel® spreadsheet software for performing scientific data aggregation, analysis and presentation. While the legacy spreadsheet tool was flexible, it was also slow. With the amount of data growing year after year, scientists had come to accept the inevitability of some queries taking up to 3 hours to process. By implementing a faster, more purpose-built tool running BIOVIA Pipeline Pilot protocols in Microsoft Excel spreadsheets the company has much more than simple spreadsheet capabilities.

  • With nearly 2,000 scientists and twice as many instruments spread across multiple global locations, the customer was managing eight different electronic notebook (ELN) systems and Laboratory Information Management Systems (LIMS). The customer’s challenge was to unify data collection and management across the different phases of early discovery, R&D, and clinical and commercial manufacturing. By implementing a comprehensive agile framework, the customer and BIOVIA were able to release 3 major and 2 intermediate software iterations within 12 months.

  • Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.

WHITE PAPERS

  • With cloud adoption significantly enhancing collaborative projects, increasing operational agility and lowering total cost of ownership (TCO), cloud computing has become a valuable and viable solution today; however, organizations are often uncertain about the best way to evaluate, select and implement a cloud collaboration platform. This paper will discuss the challenges of internal and external collaboration and how scientific research organizations can manage the transition to a more highly performant, flexible and agile partner workspace in the cloud with the help of a qualified cloud provider.

  • As this next wave of antibody-based therapies gains momentum, biochemists have begun to create even more innovative molecules with additional modes of action including multispecific antibodies and other so-called Frankenmolecules. However, informatics technologies have not kept pace with these scientific innovations. It’s unlikely that any single life science company, technology vendor or academic group will be able to solve these issues unaided. But together we can establish systems and processes that make working with these new entities more efficient.

  • With many biotherapeutics a strong immunogenic response can limit the effectiveness of the treatment or cause a more serious illness. This remains a challenge for scientists as the underlying mechanisms of unwanted immunogenicity still aren’t completely understood. Detecting and preventing unwanted sources of immunogenicity as early in the discovery process as possible has become a top priority for research organizations since biotherapeutic development becomes increasingly costly as it moves downstream.

  • Identification of Medicinal Products (IDMP) is an international pharmacovigilance and patient safety initiative addressing this need for global identification of regulated pharmaceutical products during their lifecycle. IDMP is an opportunity for pharmaceutical companies to transform the way in which the continuity of digital information is leveraged and presented to provide a complete definition of the medicinal product, bringing immense business benefits and competitive advantage.

  • The costly proliferation of parts and components that often accompanies the pressure for product differentiation and customization can be controlled through multiple strategies. One of the easiest and most effective of these is to deploy EXALEAD Sourcing & Standardization Intelligence. By combining information sources with semantic information, these new products and applications go beyond the limits of conventional analytics solutions and deliver simple user experiences for decision makers.

GUEST BLOGS

  • Working in a cloud-based information management and collaboration workspace provides a level of business agility and security that is not available with server-based, on-premises infrastructure.

  • Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.

  • “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.

  • Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.