Optimize Scale-Up for Vaccine and Therapeutic Manufacturing

Accelerate development and manufacturing in the era of SARS-CoV-2 

To meet the urgent demand for SARS-CoV-2 vaccines and therapeutics in the shortest possible timeframe, many companies are designing their scale-up processes in parallel with Phase III clinical trials, redefining the risk tolerance for everyone involved. To satisfy commercial requirements for expedited scale-up, the molecule can no longer dictate the technology transfer process into the manufacturing facility. Shifting the focus from optimizing an individual process to an entire biomanufacturing workflow requires companies to adopt a new mindset and consider new ways of doing business. Success can be achieved by concentrating on three key activities: reviewing capabilities, assessing your risk tolerance, and identifying additional resources to accomplish your goals. 

Rethink your current capabilities 

Could product standardization help to better meet demand? Product standardization has advantages. For example, selecting single-use bioprocess containers with consistent materials and components makes it easier to achieve consistent results. There is less variety in the materials of construction, which reduces the number of validations or in the case of a new material of construction—revalidation—necessary. Standardization also ensures that the same components are used throughout the process. Therefore, parts are more likely to be in stock from both the vendor and the sub-supplier to the primary vendor, and internal training at the site is minimized because fewer diverse components are in use.  How will you share data and maintain data integrity? Ideally, one automation and control platform would be used from R&D through manufacturing. Not only would selecting one platform help ensure data integrity, but it would also help to mitigate capital expense and operational costs. The more additional equipment that needs to be purchased, the more likely it is that you’ll need to invest in facility upgrades, personnel skills and training, and chemical formats, making supply chain adjustments necessary.  It’s important to determine if you have in-house manufacturing capabilities that can scale to compete in an accelerated race with other developers and manufacturers for first-to-market vaccines and treatments. Critical process optimization considerations include equipment, capacity, chemicals, consumables, a skilled workforce, and supply chain flexibility with redundancy. 

Consider these questions: Has your organization committed to the development of robust time-and-motion modeling approaches at scale to drive decisions? At scale, time-and-motion models are incredibly powerful tools when correctly integrated into an organization. These models become the foundation of all engineering and resource-specific questions when predicting if the current capabilities of an organization can scale to meet the challenges of a novel project. To understand the significance of these models, consider how much time it takes from the start of equipment setup to the end of equipment breakdown. Organizations without significant experience developing time-and-motion models are well advised to seek a partner with that expertise to bridge the gap between current capabilities and future requirements. 

Will your current head count be able to support the increase in demand? Outsourcing workflows that include process liquid and buffer preparation can enable you to focus your work force on optimizing other processes. Receiving process liquids and buffers as they are needed for production eliminates the need to precisely weigh, dispense, and hydrate dry chemicals. The time spent setting up, working in, breaking down, and cleaning up work areas for bioprocessing steps tends to be underestimated. Staff need to be specially trained for each of these steps, with additional trainings required for handling hazardous materials. Letting experienced professionals handle noncore activities like those described above, will save time, money, and storage space in the long run.  

Have you considered secondary sourcing and stocking agreements to improve on-time-in-full (OTIF) performance? Secondary sourcing is a key safeguard for mitigating production delays. Suppliers with global manufacturing capabilities and networks can enable you to specify raw materials from alternate suppliers into your processes. If the primary supplier runs into unforeseen supply chain issues, such as material unavailability or long lead times, you have ready access to raw materials from back-up suppliers. Stocking agreements are another safeguard to ensure raw materials are delivered on time, and in the order’s entirety. 

Where to find additional help and support

As we look toward the future, therapeutic and vaccine development is likely to continue to accelerate. Companies will need to review critical actions to optimize vaccine and therapeutic manufacturing and remain competitive. It will be necessary to assess your current capabilities and consider partnering with experts that can bridge the gap between your current capabilities and future, to optimize scale-up processes. 

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