“The longer new therapies are held up in the development stage, the longer patients wait. The months, days and hours matter, especially to patients on their last line of treatment.”
John MCCARTHY
Life Sciences & Healthcare Industry,
Business Value Consultant Senior Director,
Dassault Systèmes
Despite the incredible advancements in the Life Sciences and Healthcare (LS&H) industry, drug shortages are still prevalent today1.
Out of the hundreds of thousands of molecules screened in early research and development, few ultimately achieve approval and commercialization. Disconnected processes and supply chain inefficiencies add to the complexity of getting new therapies to market.
The biopharma R&D process — from drug discovery to development — is costly, lengthy and risky. A new therapy can take 10 to 12 years to progress from discovery to launch and incur capitalized costs exceeding $2 billion2.
Today, pipelines of biologics, including cell and gene therapies, are increasing, and their complexity demands new methods and real-time analytics for process efficiency and predictability.
To get to market first, biopharma companies must forge a digital backbone — a connection made possible by Dassault Systèmes’ solutions and the virtual twin experience on the 3DEXPERIENCE® platform.
This connection raises the bar for closer collaboration and synergy between development labs and manufacturing operations — and the connection of people, processes and data.
Read this guide to learn how a digital backbone can help your teams harness synergy throughout the product lifecycle to bring sustainable, high-quality new therapies to market faster and more efficiently.
THE URGENCY
TO DELIVER NEW
THERAPIES
1 CNN Health (Mar 2022)
2 Deloitte’s 13th Annual Pharmaceutical Innovation Report (Feb 2023)
MAP OF CONTENTS
Click
to explore each chapter
“The longer new therapies are held up in the development stage, the longer patients wait. The months, days and hours matter, especially to patients on their last line of treatment.”
John MCCARTHY
Life Sciences & Healthcare Industry,
Business Value Consultant Senior Director,
Dassault Systèmes
While many biopharmaceutical companies have automated routine tasks such as data capture and documentation, not all development labs are fully connected and
digitalized.
The traditional methods of making phone calls or sending out emails to check the status of results are not productive.
Say that your bioprocess lab needs to improve yield and purity, and they need to identify the optimum cell media and conditions for cell growth using the least possible materials. Will your scientists have to repeat 30 to 50% of the lab work because there’s no traceable knowledge from previous experiments?
Not anymore.
Through a connected digital backbone and the virtual twin, scientists can reuse 80% of lab experiments and compare results quickly and effectively instead of duplicating previously done work.
ARE THE RESULTS
READY?
For example, scientists can build virtual twins of bioreactors and cell culture production processes to determine optimal cell harvest times while ensuring Quality By Design (QbD) and accelerating the biologic therapy.
“By having everyone from all labs working in a single environment, they’re able to collaborate more quickly, return the response to laboratory workflows more quickly, and accelerate drug development time,” highlights Kevin O’Leary, BIOVIA’s Vice President at Dassault Systèmes.
O’Leary adds: “In a fully digitalized environment using the virtual twin, scientists can see patterns over a period of time, predict improvements, and execute more accurately and more consistently, which scales well to their production environment. By doing this digitally in the development lab, they can quickly move into the tech transfer world and apply future improvements consistently, globally.”
FROM PAPER
TO DIGITAL
METHODS
In development labs, the process chemistry, upstream and downstream bioprocess, formulation and analytical testing must happen quickly.
However, paper-based processes create bottlenecks and slow the exchange of the results of experiments.
With digital test methods, scientists can consider improvements at any point. For instance, they can assess the likelihood of changes against other test methods in the past, evaluate the impact of changes downstream, and verify virtually to make it better in the real world.
Data traceability is critical as
treatments move from discovery through development to clinical manufacturing, manufacturing
and commercial operations.
In too many cases, companies spend too long finding and giving evidence of how a batch was produced by searching through disparate records, systems and paper documents. This inefficiency illustrates a breakdown in the chain of evidence between what was produced and how it was produced.
“From cell line development to a purified antibody, the end-to-end view across the product lifecycle accelerates the exchange of knowledge, improves quality and compliance, and provides much certainty,” explains O’Leary.
Powered by the 3DEXPERIENCE platform, Dassault Systemes’ ONE Lab solution supports all the scientific workflows and processes biopharma companies have to create new and novel therapies.
DIGITALIZED CHAIN OF
EVIDENCE
By digitalizing the biologics lab, chemistry lab, formulations lab and analytical lab, companies can harness synergy to:
PROOF POINTS
Sustainability is ranking high on the priority list for biopharma companies. To deliver more affordable therapies, companies need to focus their efforts on reducing the cost of goods sold and lowering the carbon footprint.
By optimizing processes through a connected digital backbone and the virtual twin, development labs can gain answers to the following questions:
Will fewer reaction steps in process chemistry lower the use of certain chemicals while increasing the yield significantly?
How do we stimulate cell growth in the bioreactor with the least materials to produce the biologic faster?
What is the impact of using green solvent systems in producing a specific therapy?
How can we reduce the heat produced during manufacturing and lower cooling costs?
Can we reduce the likelihood of waste or impurities that may be difficult to dispose?
What is the origin and carbon footprint of ingredients used?
PRODUCING
SUSTAINABLE AND AFFORDABLE
THERAPIES
By simulating process improvements, scientists can run multiple scenarios with the objective of finding the optimal configuration, increasing accuracy and reducing waste, including related emissions.
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SPOTLIGHT
“Take CAR-T therapies as an example. Once patients have their blood plasma taken at the hospital, it can take anywhere from 17 to 30 days for them to receive the treatment. By digitalizing lab data and processes, we can avoid unnecessary manual reviews and speed up turnaround time.”
John MCCARTHY
Life Sciences & Healthcare Industry,
Business Value Consultant Senior Director,
Dassault Systèmes
“Digitalization of tech transfer assets
and processes like CMC content authoring can
slash time and effort by 50%. This could save
around $2 million on each submission.”
Kevin O’LEARY
Quality & Compliance Vice President,
Quality Regulatory & Structure,
Dassault Systèmes
Completing tech transfer is highly intensive and can take 18 to 30 months. From small molecules to biologics, each biopharma tech transfer comes with its unique constraints.
Lack of synergy between companies, supply chain and logistical inefficiencies, and inconsistent quality add to the complexity and can extend the time to market.
A successful tech transfer relies on a few factors, including:
Stronger collaboration between manufacturing operations and development teams through a digital backbone and the virtual twin can increase the performance of tech transfer or effectively decrease the time it takes to introduce new products to the market.
“The virtual twin forms a universal language, forging closer collaboration between scientists, biologists and process engineers. This helps to improve the tech transfer process,” says Guillaume Kerboul, the LS&H Industry Value Expert Director at Dassault Systèmes.”
OPTIMIZE
TECH TRANSFER
ASSETS AND
PROCESSES
IDMP compliance requires that the information sent to regulatory agencies be consistent in format and ISO coding. Therefore, consistent, detailed data ontology is critical throughout all phases. For example, what are the temperature and storage conditions? How will different pH levels alter the product? Digitalizing IDMP and product specifications with the License to Cure solution simplifies a shared understanding across markets and regions.
The implications of CMC (chemistry, manufacturing and controls) content authoring can ripple across the lifecycle. If there are future changes to production, the CMC content has to be regenerated and reapproved. This is a complicated and time-consuming process, hampered by multiple contributors, endless verification loops, several updates to charts and tables — and the list goes on.
O’Leary adds: “Nobody loves how CMC content authoring is done today. Precious time is spent on inefficient workflows that can be automated and simplified — which is why we’re transforming the process.”
The License to Cure solution creates a digital thread from the source system to all charts, tables and data points in the CMC, which can be verified and reused. Companies can also see the implications of making changes for resubmissions. This accelerates the time to generate the CMC — and shortens time to market and simplifies future changes to production.
To scale up from development to manufacturing and achieve a successful tech transfer, companies can opt for Dassault Systemes’ License to Cure solution powered by the 3DEXPERIENCE platform. The solution allows leaders to manage all products, recipes, specifications and methods in a collaborative digital ecosystem.
PROOF POINTS
“With a virtual twin, companies can simulate improvements or changes while considering factors like quality requirements, price fluctuations, manufacturing costs, and delivery proximity to patients. All before a single therapy is produced.”
Guillaume KERBOUL
Industry Value Expert Director
Life Sciences & Healthcare Industry
Dassault Systèmes
As biopharma manufacturing lines transition towards small batch production, companies need highly agile and flexible manufacturing operations. Keen to optimize your manufacturing line and recipe before they exist? With the virtual twin, you can unlock greater synergy in manufacturing.
“The virtual twin grants companies and their contract manufacturing partners the ability to standardize their manufacturing processes. They can recreate new recipes, evaluate alternative lines and configurations and analyze quality deviations. This saves time and drives higher safety standards,” explains Kerboul.
The success of full-scale biopharma manufacturing relies on the connection
of systems, people and data through a digital backbone.
With the virtual twin and Dassault Systemes’ Made to Cure solution on the 3DEXPERIENCE platform, companies can:
END-TO-END
MANUFACTURING
OPTIMIZATION
PROOF POINTS
“We knew that production was going to increase and there
was already a bottleneck in the washing area. This is a very simple environment: The dirty formulation tanks are brought in, get disassembled, cleaned, reassembled and sterilized, and then they are sent back out to production.”
Mary OATES
Head of Vaccine Manufacturing, Sanofi
The global pharmaceutical and healthcare company leveraged virtual twins of its vaccine manufacturing plants and processes to:
Test, refine and implement improvements
Enhance quality and worker safety
Reduce costs
Ensure ample drug supply
“We can accommodate the additional manufacturing volume without
increasing resources inside the washing area — simply by making the
improvements we identified.”
Automation may hog the limelight, but the virtual twin is the secret to eliminating manufacturing quality issues. Take a page from Sanofi.
SPOTLIGHT
VIRTUAL TWINS
PRODUCE BETTER VACCINES AND
FASTER
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We’re at a transformational point in the industry. Biopharma companies want to connect development,
tech transfer and manufacturing operations, and our mandate is to get there quickly.”
Kevin O’LEARY
BIOVIA Quality and
Compliance Vice President,
Dassault Systèmes
The biopharma market is expected to grow at a CAGR of 7.1%, to reach $720 billion by 20303.
For companies, the question is no longer whether to embark on a digital journey for their supply chain and global operations functions. Instead, it’s about how to connect all the pieces through a digital backbone.
Closer collaboration and the integration of data and technology can reduce time to market by 20 to 35 months. The combination of Dassault Systèmes’ solutions, the virtual twin and the 3DEXPERIENCE platform will enable biopharma leaders to bridge knowledge, quality and speed — and deliver breakthrough therapies to patients.
3 Prescient & Strategic Intelligence (Sep 2022)
EXPERTS
McCarthy has worked with leading companies in life sciences, consumer products and chemicals industries to deliver software-based solutions to increase the pace of innovation for the past 30 years.
An accomplished business strategist, McCarthy is passionate about working with clients to understand their scientific, engineering, and business challenges and identifying solutions to them.
John McCarthy
Life Sciences & Healthcare Industry Business Value Consulting Senior Director, Dassault Systèmes
