According to CRB’s 2022 Horizon Report, 90% of survey respondents stated that they are developing and manufacturing multiple therapy modalities in a single building or planning to do so in the future.
Considering this, it’s safe to say that multimodal manufacturing is poised to become a significant trend in 2023 and beyond.
Multimodal manufacturing refers to a pharma company creating more than one product or undertaking different manufacturing processes within the same facility. Companies use this approach to see quicker, more streamlined processes and ensure the quality of their end products.
Developing multiple products simultaneously comes with many exciting opportunities for companies, but, like any shift in your day-to-day operations, it can bring challenges.
Benefits of Multimodal Manufacturing
While there are many benefits to multimodal facilities, the three key advantages are:
1. Quicker Time-To-Market
We saw the need for quick, agile operations during the pandemic when creating the COVID-19 vaccine, and manufacturers responded. With so many companies racing against their competitors to launch their products first, reducing time-to-market is more important than ever. Multimodal facilities make faster, more efficient production possible.
2. Increased Flexibility
One of the main appeals of multimodal manufacturing is increased flexibility. With modular cleanrooms, quickly adapting to changing therapy variations and requests from regulators is much easier than in a traditional setting.
3. Cost Reduction
By using soft-wall and modular GMP suites within a facility, pharma companies can lower their initial capital investments and reduce costs over time.
Challenges of Multimodal Manufacturing
Similar to implementing other innovative solutions, multimodal manufacturing comes with its challenges. However, with the proper knowledge, guidance, and strategy, pharma companies can overcome these difficulties and reap the benefits.
1. Technology Selection
With multimodal facilities being a relatively novel concept and working within a rapidly evolving CGT field, choosing the right technology to help you reach your goals can be challenging. Working with an experienced commissioning, qualification, and validation team will make technology selection a smoother, more straightforward process.
2. Validation Staffing
Finding professionals with the correct mindset and expertise needed for multimodal facility validation can be daunting, especially considering the current competitive staffing landscape. Utilizing CQV staff augmentation can help you ensure you have the tight validation staff on-site.
3. Quickly Evolving Technology and Regulations
Technology, regulations, and processes are constantly changing. Keeping all aspects of your multimodal facility up-to-date and compliant while maintaining speed can be difficult. Companies can avoid holdups by designing a highly flexible and reconfigurable facility.
4. Supply Chain Issues
Due to ongoing supply chain issues, obtaining certain items and materials such as plastics on time and within budget isn’t always guaranteed. These issues can cause disruptions to tight timelines. Because multimodal facilities are extremely adaptable by nature, adapting to these disruptions is easier than in a traditional facility.
5. A Traditional View on Capital Investment
Another potential challenge is taking the same approach to capital investment as you would with a traditional facility. Investing in a modular suite for your multimodal facilities involves less risk because you can create different products, not just one. The new trend is to negotiate a not-to-exceed pricing model on construction costs.
Considerations to Make
Pharma companies must be cautious when selecting their A&E firm and CQV partners. Multimodal facilities require a “blank template” design approach to GMP suites, allowing for accelerated fabrication and off-site construction. There is a limited amount of A&E firms that have the experience, resources, and capabilities to design and construct these facilities using template-based, functional GMP suites.
Similarly, only a handful of CQV partners have the vast expertise needed to put that pragmatic approach to work. Pharma companies must be very selective with whom they trust to execute their products, timelines, and compliance/regulatory needs.
Our team of CQV experts has the right knowledge and experience to help your company with its multimodal manufacturing needs.