eBook: Revolutionize Your Lab With a Cutting-Edge Bioprocess Platform To Drive Quality and Efficiency
Tackling Rising Costs and Reducing Time to Market
Having broken global sales records in the past, biopharmaceutical companies are now seeing consistent industry growth and have been valued at billions of dollars in 20181. A study from 2016 has also found that the average cost of new drug and biologics development is now in excess of $2.5 billion and growing at a rate of more than 8% per year2.
With the right solution organizations can simplify their lab-based working, while ensuring the highest level of compliance with regulatory requirements, ultimately savings costs and reducing time to market – but it can be hard to know where to start.
In this eBook, we explain how you can harmonize bioprocess execution, increase efficiency, and ensure seamless cross-departmental collaboration across cell line development, process development and analytical development all within a secure, accessible and powerful end-to-end solution for Bioprocess workflows.
Maintaining Quality Assurance
According to the FDA, invalid or unreliable data is a sign of poor control of equipment and operations.
By using a single integrated system, organizations are able to capture information and centralize data into an electronic development record. With a development platform that’s integrated with other systems and instrumentation, errors can be engineered out of a workflow, either through prevention or, where prevention is not possible, by unambiguously alerting a user or reviewer to a deviation. This facilitates an ‘audit by exception’ approach, which has been demonstrated to significantly reduce review times and free up QA resources to focus on critical issues.
Storing information in a compliant, unified environment across the product and process lifecycle, means that organizations can also deliver configurable workflows based on industry best practices and even cope with validation and GxP compliance demands.
Streamline Technology Transfer Between Labs and Teams
Working in teams across different laboratories can cause a variety of logistical problems, with various parties needing to co-ordinate activities, transfer data and generate reports.
According to the ICH Q10 guidelines3, “the goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
Whether the technology transfer takes place internally or across different organizations including CDMOs (Contract Development and Manufacturing Organizations) and CROs (Contract Research Organizations), efficient process development, data capture, shared process knowledge and collaboration becomes critical for having a streamlined technology transfer. Keeping an electronic record reduces and even eliminates many of the data collation and checking activities. It not only saves effort, but it can also bring forward the delivery of a technology transfer dossier by at least three weeks. The IDBS Bioprocess Solution customers have reported a significant improvement in efficiency, knowledge sharing, cross departmental reporting and process insight.
Our Customers Have Seen:
When you consider that a typical development phase (post early research and prior to clinical trials) accounts for three years and 20-25% of the associated costs of bringing a drug to market, three weeks doesn’t sound like a huge amount of time to save – but it could be worth $18 million.
Improving Quality Through Traceability
When data is spread across multiple systems, the ability to trace source information is dramatically compromised, making it difficult to even identify if, and when, critical information is missing. This can result in lengthy investigations towards the end of the development process, often taking months to complete and repeat any required batch runs.
Investigations, in turn, divert the attention of development teams – reducing their capacity to work on other development projects resulting in a detrimental impact on the entire R&D pipeline.
There are other issues too. Silos introduce redundancy, meaning the same information is often stored in at least two, or more, separate places. In instances where this information is conflicting, it’s usually unclear which version is correct therefore impacting the quality of work.
By using an end-to-end R&D platform, organizations can put an end to these headaches, not only increasing the traceability of information but also increasing the traceability of materials as well. Being in the cloud means the platform is accessible, collaborative and secure.
By maintaining linkages (between batch preparation, processing and use, for example), a scientific data management platform can automatically create a searchable genealogy. The details of all processing steps can be recorded in the same system, making it possible to track the progress of the batch process from one unit operation to another.
This also aids troubleshooting. If an issue is identified with a particular lot of drug or excipient, process engineers can rapidly determine where it has been used and identify all batches that are affected.
Reducing The Cost of Repeated Batches
Unnecessarily repeating work is an expensive business. A single repeated experiment can contribute between $1,500 and $20,000 to the cost of development, and a single error in offline testing can cost businesses $100,000.
It’s easy to see how these costs add up. You have the costs of reagents, personnel time for investigation, write up, review and re-execution, and even the costs of the instrument, which can cost $100s per run.
The two most common reasons for needing to repeat an experiment are missing information and deviations during execution, including using out of date reagents or equipment that is out of calibration. When completing paper forms it’s possible for analysts to omit information by mistake resulting in an incomplete experimental record. A reliance on paper or disconnected file-based systems to store experimental data not only means it takes time to find vital information, it often results in lost or inaccessible data.
By using an electronic system, organizations can ensure that all critical data is captured at the point of conducting the experiment and highlighting out of range values as soon as they are entered, enabling issues to be addressed in real time, and reducing the need for time-consuming, costly repeats.
And, of course, the benefits aren’t purely financial. Reducing repeats will also help you deliver in a shorter timeframe…
Delivering In a Shorter Timeframe
According to one study by Lilly Research Laboratories, bringing time to market forward by a week could reduce out of pocket expenses by $6 million4. Yes, really $6 million.
Save time and save money. Sounds good! Question is: ‘how?’
Process development teams, Analytical Development and QA/QC teams are continually challenged to deliver results faster. However, in the absence of a modern informatics infrastructure, analytical teams can only manage their workload reactively and deal with problems retrospectively, which results in reduced agility and capacity. Fortunately, an end-to-end R&D data management platform can help.
A modern informatics system will include built-in requesting capabilities, which provide laboratory managers with early insight into the workload coming their way, so they can make more informed scheduling decisions. This results in better utilization of resources, not just people but also of efficient use of costly materials and reduction of expensive instruments sitting idle.
Analysts also receive far richer information about the samples they receive than is possible using typical requesting systems. Knowing how the process material, the sample was taken from, was made and understanding the purpose of the process scientist’s experiment, the analyst can quickly determine the appropriate test strategy to take. For example, they can check how the material was processed prior to receipt and find what buffer or solvent was used and adapt their assay procedure accordingly, such as selecting the most appropriate marker, standard to use or dilution for their samples.
The benefits don’t stop there. By integrating inventory and barcoding with experimental execution, error-prone and time-consuming manual data entry is reduced – meaning process engineers and analysts can simply scan a reagent and automatically populate details such as batch number and expiry date within the electronic execution record. Saving effort, and bringing forward the delivery of a technology transfer dossier by at least three weeks.
Improving Data Visibility and Accessibility
The development of a novel therapeutic or a new drug product candidate requires an ever-diverse range of activities performed by specialist teams. Historically, many biopharmaceutical companies have devolved a selection of data management systems to each of the different subpopulations within the organization.
While a department-centric approach can result in incremental efficiency gains within specific areas of the business, the potential for more impactful improvement lies at the interfaces between departments and are difficult to realize when data remains in silos.
To gain a comprehensive understanding of the biopharmaceutical value chain, a more holistic view is required. Reagent preparation teams, Analytical Development, QC, and other departments that support drug development, should be seen as a critical part of the process rather than treated as ‘service’ groups. Similarly, the continued growth in outsourcing to strategic partners such as contract development and manufacturing organizations (CDMOs) means that rather than a linear flow of material and information, the process of concept to commercialization of a drug is best viewed as a network that extends beyond traditional organizational boundaries.
While this results in an increasingly complex picture, the communication within and between organizations can be vastly simplified when all participants in the journey from early Development through to Clinical Manufacture use a common integrated platform, eliminating manual handoffs and streamlining requests.
A collaborative, integrated platform can also enable organizations to manage inventory, equipment and reagents all from the same system – resulting in a complete searchable, context-rich record of the execution of a process and everything connected to it.
Transforming Focus To Science, Not Software
Historically, data has been captured in silos, so harnessing the power of data can be tricky – particularly for bioprocess organizations.
Bioprocess data tends to be far more contextually rich than other sectors, with a multitude of factors all working in conjunction. And, when compared to other industries, there’s also a greater segmentation of where work is occurring and a wider variety of unconnected tools – meaning there’s a lot less standardization, too. The end result for research teams? Trying to tie all that data together, particularly as the volumes grow, can be pretty complex and time consuming.
Organizations require flexibility to manage process development and execution changes while still capturing and managing the intricately linked data. However, due to rigid legacy data management structures, organizations were previously focused and limited to a specific set of needs or demands: for example, ‘for research we need an ELN’ and ‘for our analytical group we need a LIMS’.
So now, companies are looking to move away from these restrictive and outdated silos of information and data and are increasingly looking towards more harmonized solutions, as they realize that all data is part of the same, big picture.
The IDBS Bioprocess Solution
The IDBS Bioprocess Solution, our bioprocess execution system, is specifically designed to meet the challenges faced by biopharmaceutical professionals.
By using the IDBS Bioprocess Solution, organizations can streamline their process execution and Quality Assurance – eliminating up to eight hours of wasted effort per scientist, per week.
Whether you’re carrying out daily monitoring of your bioreactors or performing critical testing of bioprocess samples, the IDBS Bioprocess Solution improves business performance by streamlining process execution and delivering unparalleled product and process insight.
It provides the required workflows, reports and reporting, sample tracking, instrument integrations and full implementation documentation (IQ/OQ), in a single packaged cloud offering for all laboratories in the bioprocess space. Cell line development, scale up, purification, analytical, and clinical supply groups can now get access to the considerable return on investments (ROI) and state of the art quality assurance (QA) that come from deploying the IDBS Bioprocess Solution.
Leveraging the IDBS E-WorkBook Cloud platform, the solution provides an out-of-the-box capability that enables cell line development, fermentation scale up and purification, and clinical supply workflows to be executed in a single, unified, and compliant informatics and data management environment.
Scientists can quickly compare batches, sample results and other key product and process attributes through preconfigured reports or ad-hoc analysis.
Our system provides a compliant, harmonized environment across the product and process lifecycle, and delivers configurable workflows based on industry best practices. This includes molecular biology and cell line optimization, upstream and downstream process development, supporting analytics and pilot plant operations.
• Gain a holistic view of your products’ processes with full traceability, enabling better decision-making and improved insight
• Facilitate collaboration between upstream and downstream development, and support groups such as analytical development
• Optimize processes and prevent common errors using built-in workflow execution capabilities
• Search data with context, supporting more meaningful queries and faster report generation and tech transfer.
Are you ready to move your bioprocess systems into a platform that provides end-to-end visibility, traceability, accessibility and security that will reduce the time, effort and resources required, giving you a faster time to market and saving you money?
Talk to Our Experts Today
Using our many years of experience, we have ensured that our solution meets the rigorous regulatory requirements and have successfully delivered our bioprocess solution to a wide range of customers. If you are ready to learn how the IDBS Bioprocess Solution could help you, talk to one of our experts today.Download now More info on Biologics Request a demo