Welcome to Part 3 of our preclinical, clinical, and commercial manufacturing series.
In Part 1, we explored the entire drug production lifecycle, and then examined what happens at the preclinical stage.
In Part 2, we analyzed clinical drug production and how digital manufacturing execution systems are used from preclinical to commercial stages.
Now, we’ll take a deep dive into commercial production by examining what’s at stake and what needs to happen for a drug to go to market. In conclusion, we’ll outline how pharma companies can modernize and optimize commercial drug production throughout the entire lifecycle.
Commercial drug manufacturing involves a lot of moving parts that need to be considered including supply chain disruptions, inventory management, collaboration across teams and sites, and beyond. As such, to be successful in bringing new therapeutics to market, companies must approach manufacturing with agility and flexibility.
However, this is often easier said than done. Many pharma companies still rely on outdated processes such as paper records and on-premise legacy systems for manufacturing. Although these systems are tried and tested, they weren’t built for modern manufacturing and create bottlenecks in the production process.
Here are some frequent challenges commercial drug manufacturers face:
In order for pharma companies to replicate the COVID vaccine production model, they need to have a consistent digital solution across manufacturing operations. This means data is accurate, visible, and available in real time across sites and teams.
The problem with on-prem legacy solutions is that they’re siloed across individual sites, meaning the information contained within them is only available to certain people, in certain locations. As such, collaboration is stifled and teams may be working from inaccurate or incomplete data. This leads to redundancies like the duplication of work, wasted resources, and processes deviations.
By leveraging cloud-based systems, companies can work as one team from anywhere while seamlessly managing workflows and processes across sites.
“While many commercial manufacturing teams leverage digital solutions today, there are limitations with existing on-premise technology. A main limitation is lack of connectivity to other sites and teams, which makes initial scale-up and technology transfer challenging.”
— Anastasia Wengrowski, VP, Strategy, Apprentice
Modernizing commercial drug production allows companies to bring new drugs to market sooner. It also reduces the risks associated with each stage of development, and helps companies adhere more stringently to quality standards and regulatory requirements.
The importance of this cannot be overstated. Given the competitive nature of drug development, volatility of the market, and high failure rates, pharma companies need all the help they can get to reduce the risks, while increasing their chances of success. Companies that opt to stick with manual processes or outdated solutions will eventually be left behind, unable to compete with the quick pace of the market.
Although many pharma companies are equipped with MES solutions for commercial manufacturing, many of these solutions are outdated and on-prem. As a result, information can’t be shared in real time, which hinders collaboration and may result in resource waste.
Companies that choose a cloud-based solution remain more competitive in the market because they’re able to bring products to market sooner, without sacrificing quality or safety along the way.
And if you need another reason beyond those listed above, consider this statistic:
Here’s our advice: Select a suitable MES solution from the start. This will enable you to avoid unnecessary issues down the road, and ensure your organization is set up for success from day one. If this isn’t an option because you already have an MES system in place, then take the following steps to modernize your commercial manufacturing operations:
We know that’s a lot to swallow. But before the fire alarms sound off, note that there’s no need to make a wholesale pivot from paper to digital, or from on-prem to the cloud.
Change management works best when it’s approached thoughtfully, so consider incremental changes that can start moving you towards your goals. Create a tiger team of digital champions who can start working with a new technology, pilot it, and then make recommendations on how to grow it out from there.
As with any big change, modernizing your drug production process will take time.
Have patience as you work to make changes, make sure communications are coordinated across the entire organization, and do your research. Don’t just go with any system that claims to offer the benefits listed above, make sure the solution you select can also deliver on its promise.
Perfecting a therapeutic product and bringing it to market is no easy feat. It takes an average of 12 years, trial and error, and millions (sometimes billions) of dollars.
So, what’s at stake during the commercial stage? Everything. Time. Money. Resources. Your company’s reputation. And most importantly, your product.
To accelerate commercial production, pharma companies need to connect operating suites and collaborators across geographies and facilities. As such, they must ensure whatever digital solutions they’re using are capable of detailed record keeping that allows for seamless transfers across sites, teams, and organizations.
“Modern digital solutions are becoming increasingly important in the pharmaceutical space because they can drastically reduce speed to market for life-saving treatments, getting medicines to patients faster.”
— Anastasia Wengrowski, VP, Strategy, Apprentice
Having a system that’s easy to use, and provides stakeholders with clear visibility throughout production can mean the difference between success and failure.
Improve your company’s go to market strategy — from preclinical benchtop to large-scale commercial manufacturing, by leveraging our Tempo Manufacturing Execution System (MES). Tempo keeps your global teams connected, empowered, and in sync. It’s flexible, yet powerful, features let Tempo grow with your process from preclinical experimentation to commercial standardization.
Want to learn more about how you can scale faster and smarter with Tempo MES? Get in touch with our team and we’ll show you how.
Anastasia’s passionate about science, technology, and how they intersect. Read on to learn more about her background and insights on commercial manufacturing.
Anastasia has joined the team at Apprentice and is excited to be helping the life sciences industry improve reliability and speed to market with the Tempo platform!
Anastasia is a Certified Quality Auditor with diverse experience in life sciences academic research, regulatory affairs, quality systems, and cloud technology. She began her career conducting cardiac physiology research in a biomedical engineering laboratory, where she led projects, taught courses, and published full manuscripts. This passion for cardiac physiology led to a position as a medical device and combination product reviewer for the FDA.
At the FDA, Anastasia worked with a cross-functional team of experts across multiple centers (CDRH, CDER, and CBER) to provide premarket approval for implantable electrophysiology devices such as pacemakers and drug-coated leads. Anastasia then spent several years working in the life sciences industry, where she learned all aspects of the quality system and also implemented an electronic quality management system.
From 2018 to 2021, Anastasia worked at Veeva Systems. She spent time as an implementation consultant before moving over to the Vault Quality strategy team, where she was responsible for growing and supporting Veeva's customer base in the life sciences market.
In her current role of VP of Strategy at Apprentice, Anastasia helps pinpoint and resolve common challenges faced by manufacturers across the drug production lifecycle — from preclinical through clinical to commercial manufacturing.
“It’s a common misconception that digital solutions are necessary only for commercial stage drug manufacturing, in order to optimize production and maintain compliance.
In reality, implementing a flexible, modern solution earlier on in the development and manufacturing process (as early as the preclinical stage) can accelerate the drug development lifecycle by removing barriers, providing access to data, and facilitating tech transfer.”
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