4 Questions to Determine If a Single-Use Bioprocessing Facility Is Right for Your CMO
Weighing the Scalability, Costs, Compliance, and Sustainability to Make the Best Decision for Your Bioprocessing Facility and Its Product Pipeline
Table of Contents
As Biopharma continues to shift toward agile and scalable manufacturing, CMOs are being forced to decide to invest in traditional stainless-steel infrastructure or pursue a single-use bioprocessing approach. While many are looking to single-use as the future–with advantages in cost savings, flexibility, and faster production times–it also presents regulatory and sustainability challenges that must be carefully considered and managed.
How do you know if the future of your CMO facility is single-use? Our process engineering team has identified four key questions that will help you gain clarity on the goal for your facility while also helping guide your decision.
Are You Managing Variable Production Demands?
CMOs need flexible manufacturing solutions in order to support multiple clients with varying needs for their products. Single-use bioprocessing can help:
- Adapt quickly to differing batch sizes without major facility reconfigurations. This allows greater flexibility in production because traditional stainless-steel setups typically require modifications to accommodate different batch volumes. With single-use systems, production can scale seamlessly by swapping out bioreactors, tubing, and consumables as needed. This minimizes downtime and provides better support for multi-client workflows.
- Support multiple bioprocesses while reducing the risk of cross-contamination and batch failure. Stainless steel systems require extensive cleaning validation between runs, but single-use systems provide sterile components for each run, nearly eliminating any risk of contamination. This allows CMOs to run multiple client projects simultaneously, improving operational efficiency and enabling quicker product changeovers.
- Reduced Downtime by eliminating the need for cleaning, sterilization, and validation processes. Stainless steel systems require CIP and SIP processes, followed by validation to guarantee compliance before the next run can start. Single-use systems use pre-sterilized and disposable components that allow quick transitions from one batch to the next while maintaining sterility and compliance.
When comparing single-use systems to stainless steel setups, it shouldn’t be surprising that single-use systems are producing faster product changeovers. Traditional stainless-steel setups require more time to reconfigure and clean, and single-use systems eliminate these delays completely since they use disposable, pre-sterilized components. This speed and flexibility gives CMOs the much-needed agility to manage diverse production demands efficiently while reducing downtime and improving operational efficiency.
Does Single-use Save You More in the Long Run?
Debatedly, one of the biggest considerations during your decision-making process is going to be the cost. What will the actual total cost of ownership (TCO) be for these systems?
Stainless Steel systems typically require higher capital expenditures, while single-use systems will offer a lower upfront cost and more favorable TCO by reducing operational expenses in the long term. You’ll want to take these key cost considerations into account:
- Lower Initial investment: Single-use systems don’t require extensive stainless steel infrastructure or cleaning systems. This makes it more cost-effective for facility expansion while improving the overall TCO.
- Reduced Utility & Cleaning Cost: Single-use systems eliminate the need for CIP and SIP processes, cutting expenses on WFI and sterilization.
- Consumables Expenses: The cost of single-use bags, tubing, and filters is an ongoing cost and should be factored into the long-term budget for your CMO facility. Your facility must stock and source high-quality and complaint consumables to maintain process reliability and product integrity.
- Labor & Downtime Reduction: By implementing single-use systems and consumables, CMOs can lower labor costs and lessen time-consuming cleaning validation steps. These improvements result in reduced downtime and affect overall production capacity,allowing for more frequent product runs.
For CMOs looking toward cost-effective bioprocessing, a hybrid model may be the best of both worlds. Combining single-use and stainless steel components could give you the balance between scalability and cost efficiency your CMO facility needs. Single-use systems could be integrated into your process where flexibility and quick changeover are ideal, while a stainless steel infrastructure could benefit processes that prioritize long-term durability. Implementing this type of approach can help your CMO optimize production and cost by reducing capital expenditures and offering stability and regulatory compliance.
Can Single-Use Meet Your Quality Standards?
Regulatory bodies, including the FDA, EMA, and global cGMP agencies, have widely accepted single-use technology over the past two decades. However, CMOs have to guarantee their facility meets compliance and sustain regulatory alignment:
- E&L Testing (Extractables & Leachables): Single-use components must undergo rigorous extractable and leachable (E&L) testing to prevent toxic contamination and guarantee product quality and safety.
- Supply Chain Stability: Partnering with reliable consumables suppliers helps maintain batch-to-batch consistency and mitigates risks.
- Process Validation: Implementing Quality by Design (QbD) principles and clear SOPs for handling single-use assemblies is critical for regulatory approvals, including FDA submissions, EMA compliance, and global cGMP certification.
A thoughtful consumables strategy prioritizes regulatory expertise, process optimization, and product reliability. When all three of these align, CMO compliance becomes effortless.
Are You Prepared for the Environmental Trade-offs?
Even though single-use systems can offer operation efficiencies, including lower water and energy consumption, they still present concerns surrounding sustainability, specifically plastic waste management. CMOs that are evaluating a single-use strategy should consider the environmental impacts–the good and the bad–to establish a responsible and sustainable approach, such as:
- Waste & Energy Efficiency: Unlike stainless steel systems that require CIP and SIP processes, single-use facilities eliminate the need for large volumes of WFI and high temperature sterilization, reducing both water and energy consumption.
- Plastic Waster Generation: Proper disposal or recycling strategies will need to be implemented to address the accumulation of disposable plastic components from single-use system. CMOs will need to consider a waste reduction strategy that aligns with their sustainability goals, whether that’s incineration or setting up a recycling program, to maintain cGMP-compliant operations.
- Sustainability Initiatives: When looking for a supplier, inquire about recyclable, biodegradable, or sustainable single-use components. This can offset environmental concerns while supporting green bioprocessing initiatives.
- Hybrid Facility Model: Choosing a hybrid approach is always a great option. With this approach, CMOs can choose when and where to integrate single-use components or stainless steel systems. This allows CMOs to achieve greater flexibility from single-use while maintaining the longevity and scalability of stainless steel.
If your CMO is considering a transition to a single-use facility, it’s important to weigh both the resource-saving benefits and the sustainability challenges that require long-term management. Developing a waste reduction strategy in the decision-making process will help determine if a single-use or hybrid approach aligns with your facility’s operations and corporate sustainability goals.
Making the Right Decision for Your CMO
The decision on whether to proceed with a fully single-use, consumables-based facility–or even a hybrid model–requires careful analysis. The benefits include improved flexibility, increased costs savings, and enhanced productivity. But there are still trade-offs. Scalability, regulatory compliance, and sustainability directly impact your CMO facilities production goals, risk strategies, long-term financial stability, and environmental responsibility.
Unsure whether a single-use facility is the right move for your CMO facility? Our team has worked with numerous biopharma manufacturers to assess the benefits and challenges, implement hybrid solutions, and develop consumables strategies tailored to their specific bioprocesses and operational needs. Let’s discuss how to optimize your facility and product pipeline for exponential growth.
Think AES–Solutions for Better Biotech. Partner with us to evaluate and implement the right bioprocessing solution for your CMO facility. Let’s redefine what’s possible in biopharmaceutical manufacturing.