eBook: Vaccines in the digital age
CDMOs, don’t miss the train
Navigating the 2020 market
Speed, safety and strict regulatory compliance in vaccine production are essential. However, ensuring both data quality and integrity is difficult to achieve using legacy data management strategies.
In 2018, the global biopharmaceutical market was valued at about $237 billion and is expected to be worth $389 billion by 2024. The vaccine and contract development and manufacturing organization (CDMO) markets are growing with it. In fact, with personalized medicines and chronic diseases driving development, companies outsourced 30% of their drug manufacturing in 2018, and experts expect that by 2020, that will increase to 40%. Today, demand for vaccines against COVID-19 is increasing the pressure further in an already complex and competitive market, and both vaccine manufacturers and CDMOs need to increase their capacity to keep up.
In this eBook, we’ll see how digitally enabling your organization can increase capacity and improve vaccine production. Digital transformation affects every part of the business, from workflow efficiency and safety, to regulatory compliance and faster time-to-market, while also supporting CDMOs on their commitments to their clients as a service provider.
Challenges for vaccine manufacturers
Vaccine manufacturers are under high pressure to launch new, targeted vaccines in the market with short turn-around times, yet cost-effectively and while reducing risk. Vaccine research and development is unlikely to take place in the same facility as its manufacture: different teams will be handling different stages of the process across multiple labs, organizations and even countries. To ensure each step goes smoothly and safety is maximized, clear and effective communication between teams is key.
Incumbent tools such as paper records, email and storing information in static or locally stored spreadsheets increases the chance of errors and siloed data – data can get lost in emails or sent to the wrong person by mistake. These outdated practices can cause data integrity and regulatory issues down the line. For example, one company received a Form 483, an untitled letter, a WHO notice of concern, and the EMA recommended they be suspended.
Many organizations are already investing in digital tools to support their innovation. However, data management tools need to catch up. Due to increased throughput and data-rich workflows, organizations are now dealing with more data than ever, highlighting the need for a greater focus on data analytics, effective data sharing, and digital audits to augment the agility and efficiency required in life sciences.
COVID-19 is a stress-test for the industry
With increasing therapeutic demands, companies cannot afford to slow down the deployment of digital tools. Successful digitization has become a must to fulfil current demands, and hereafter. Today, companies responding to the pandemic are benefiting from risk management systems, medical diagnostic tools and syndromic surveillance systems. In addition to supporting projects now, digitization will help the industry recover and thrive in what has become the new normal.
As companies increase their R&D efforts in search of an effective therapy to COVID-19, there’s an increased need to automate processes, collaborate, and interrogate and confirm the integrity of the data. The surge in demand is pushing organizations to their limits.
What is rework costing you?
Vaccine research and development generally costs around $500 million, or $135 to $350 million, when taking risk into consideration. Facilities can cost $50–500 million per antigen, based on the high complexity of design, utilities, automation, among others. And when it comes to consumables, such as raw materials, rework and other types of wastage during the process mean that organizations need to account for more than their theoretical yield. For example, 112 million doses are required to produce 100 million doses. This adds significantly to the overall costs.
What is at stake?
Worth upwards of $35 billion today, the vaccine market has a lot on the line and can’t afford mistakes. Manufacturing a vaccine has numerous complex scientific steps, and each step generates reams of data that must be managed and leveraged effectively to reap its full potential and reduce time to market. When it comes to data integrity, regulatory bodies set high standards that continue to evolve to reflect the growing pharmaceutical market, and only those companies that have the digital tools to keep up will succeed.
Demonstrating regulatory compliance is key, with 72% of clients ranking it as one of the top factors to consider when choosing a manufacturing partner. In addition to losing client trust and strategic insight, breaching data integrity regulations could lead to warning letters, suspension of market authorization, import alerts, and delays in releasing vaccines to market.
In the past decade, data integrity violations have become more frequent. In 2018 alone, the US Food and Drug Administration (FDA) issued 85 drug GMP warning letters, 49% of which were data integrity–related. These violations included lack of adequate access controls, data not recorded contemporaneously, critical deviations not investigated, and data not fully and accurately documented. To ensure safe and quality products, regulatory agencies are enforcing good data practices and increasing scrutiny.
According to the ALCOA principles, data should be attributable, legible, contemporaneous, original and accurate. With that in mind, digitally transforming your lab is no longer a ‘nice-to-have’; now, it’s necessary. A lack of standardization in processes and technology, coupled with inefficient manual processes, can compromise data integrity and quality. On top of that, poor data management can delay and even prevent high throughput of vaccines and viable therapeutics from reaching patients.
Defining Digitalization success
If complex data isn’t captured, stored and analyzed in a standardized and accurate way, pharmaceutical sponsors will have incomplete, inaccurate and unreliable data; a risk so severe that can have lasting consequences in the development of a therapeutic. Weak collaboration and delayed or partial knowledge sharing between CDMOs and their clients can have some serious long-term impacts, including limiting productivity throughout the development process, putting business continuity planning at risk and damaging the relationship between the two parties and their reputation as a trusted service provider.
The future is now
According to research by McKinsey, leading pharma organizations are implementing digital tools, helping them achieve a 40% gain in productivity.
The key is to work smarter; by investing in a tailored digital strategy, organizations can streamline their R&D and manufacturing efforts. For example, Moderna believes that by continually investing in their digital infrastructure, they are in a good position to forge ahead with their mRNA therapies, including their vaccine for COVID-19, because this gives them confidence in their data.
Top companies in the biopharma space are investing massively in digitization. For example, Sanofi has invested €4.7 billion over the last five years towards adopting connected equipment and solutions to improve operations. This level of digitization will facilitate deploying advanced data analysis solutions and increase throughput.
Are you ready?
The path to success: the dos and don’ts of CDMO digitization
One of the main challenges in data integrity compliance is converting to digital records. Many companies end up with a hybrid system – half paper, half digital, which worsens the problem due to lack of change management and increased risk of incomplete data, creating confusion in scientists.
In fact, a poor data strategy can hold back innovation and future business growth.
CDMOs need to align themselves with their sponsors’ needs and expectations while maintaining a high standard of data integrity to stay competitive – a holistic digitalized operations model of the pharma industry based on digital maturity, data integrity, interconnectivity, and innovative technology to develop next-level therapeutics. There’s a digital revolution sweeping the pharma industry and CDMOs need to start thinking about their data strategies now. We’re moving towards Pharma 4.0, where people, physical systems and data within a process converge and use data analytics to increase product quality, productivity, and profit. CDMOs need data visibility, transparency, adaptability, and predictive capacity, all of which their clients expect, to keep up. These elements not only work in tandem to ensure pharmaceutical processes are repeatable and robust, but also provide support in accelerating both vaccine development and manufacturing processes. Implementing this approach safeguards data integrity in the value chain as well as enhances analysis for deeper understanding and decision-making.
If you’re looking to boost the reusability of your data, the FAIR principles – Findability, Accessibility, Interoperability, and Reusability – can be your guideline to enhancing how your organization captures and stores data so that it can be found and used with ease. Good data management enables knowledge discovery, insight, and innovation.
Where to start? IDBS is a biopharma digitization expert
True digital transformation gives real-time insights to the current production process and pinpoints where something went wrong. With real-time visualization of data points, managing all the components in the development so that lots can be tracked back to the exact cell line for scale up or tech transfer is not only possible, but easy.
With many years’ experience working with top pharmaceutical companies in the space, we understand the process. We’ve designed out-of-the-box solutions based on real customer feedback for the best user experience. With these solutions, CDMOs are empowered to quickly share process and product insight with their clients and provide supporting evidence on the therapeutic or vaccine that has been developed and/or manufactured as part of their services partnership. This ease of collaboration between a CDMO and customer can all be done without compromising data integrity during the process.
With the right tools, instead of spending your time manually capturing and managing data, you can focus on science. Deploying our technology is efficient and simple, and expert consultants are at hand to help. You don’t even have to maintain complex IT infrastructure, as we take care of everything.
We’ll ensure you have a safe, yet flexible, solution that is powerful, fully compliant, and ready to go.
Case Study: Lonza Biologics
By implementing IDBS software in their organization, Lonza Biologics has optimized business and individual processes, prevented errors, improved data quality, and generated context-rich data, so that it can be used more effectively. Lonza and their partners can now share information securely to boost collaboration and operational efficiencies. This has resulted in a decrease in cycle times – reducing weeks or months of reporting time to just days.
Act now! You’re one click away from building a digital competitive advantage with IDBS
In your search for data tools that match your organization’s needs, you’ll have seen all sorts of solutions and patchworks of tools, each with their own strengths and weaknesses. IDBS is different. We’ve been working with scientists and researchers for 30 years and our experience has enabled us to deliver new technology with the potential to pave the way to scientific discovery.
We provide solutions to simplify and optimize the most complex operational problems, as well as consulting expertise and technology design to fit your needs today, and further down the line.