In the competitive world of biopharmaceuticals, speed and efficiency are crucial. With the continuous demand for faster drug development and market readiness, innovations in analytical technologies that provide real-time data have become pivotal. One of the most impactful advancements is point-of-need analysis, which offers remarkable advantages over traditional methods. Here’s why innovative technology will be a game-changer for your development process.
The Power of Point-of-Need Analysis
1. Rapid Results
One of the most compelling benefits of point-of-need analysis is speed. Traditional methods, such as in-house High-Performance Liquid Chromatography (HPLC), can be time-consuming and labor-intensive. Also, external labs typically take weeks or even months to process sample results. Point-of-need analysis, for example, during cell culture media development, can provide results in minutes. This reduction in turnaround time saves weeks or even months off your process development (PD) timeline.
With at-line media analysis, we can optimize and accelerate biotherapeutic development,
— Andy Grube, Director of Upstream Process Development,
with the ultimate goal of reducing cost of goods and time to submission.”
Biologics Franchise at Resilience, a biomanufacturing company
2. Cost Efficiency
Cost savings are another significant advantage. Point-of-need analysis reduces the cost per sample. With savings per bioreactor run, it’s clear adopting this technology will result in substantial financial benefits. Furthermore, by freeing up staff, you can save PD labor costs, leading to a more streamlined operation and reduced expenses. To learn how you can save money and accelerate workflows with at-line cell culture media analysis, use our calculator tool to calculate your savings. REBEL ROI Calculator | 908 Devices
3. Enhanced Productivity
The impact on productivity is remarkable. Point-of-need analysis supports not only process development but also Good Manufacturing Practices (GMP) through continuous process verification (CPV) and qualitative media fingerprinting. This capability helps prevent deviations and optimizes process performance. With faster media development fewer experiments are needed, translating to both time and cost savings.
4. Waste Reduction
Environmental considerations are becoming increasingly important. Point-of-need analysis generates less waste compared to HPLC, addressing sustainability concerns while maintaining high efficiency. This technology also requires limited training and no method development, making it a user-friendly option.
5. Improving Product Quality and Performance
Point-of-need analysis during cell culture development is not just about speed and cost, it also plays a role in enhancing product quality. Amino acid (AA) components significantly impact critical quality attributes (CQAs), with AA depletion causing more sequence variance in suboptimized processes. By optimizing media development, you can improve product titer, reduce cost of goods sold (COGS), and avoid costly process amendments later in the development stages. Resilience demonstrated, a 50% increase in titer using REBEL, an at-line cell culture media analyzer, and reduced cost of goods by adding back only the nutrients the cells have depleted. (Resilience Demonstrates Lower Cost of Perfusion Bioreactor Process Using 908 Devices’ REBEL At-line Analyzer | 908 Devices)
Addressing the Drawbacks
Despite its numerous advantages, some detractors argue that point-of-need analysis may not be a priority for everyone. The initial equipment cost can be a barrier. Moreover, while some companies may have managed without this technology until recently, the evolving landscape of biopharmaceuticals means that investing in such innovations can lead to long-term gains. The higher upfront costs are offset by the substantial savings and efficiency improvements in the long run.
Conclusion
Investing in innovative point-of-need analysis technologies may involve upfront costs, but the long-term benefits—such as increased speed, reduced costs, enhanced productivity, and improved product quality—make it a worthwhile investment for companies aiming to stay competitive in the fast-paced biopharmaceutical industry. The future of drug development is here—are you ready to advance with innovative technology?
On-Demand Webinar Presented by BioPharm International
Nicole Azer from the FDA dives deeper into the agency’s research on implementing efficient and simplified methods for cell culture media analysis, which ultimately will lead to faster and innovative processes in biomanufacturing.
