Buffer management is a significant logistical challenge in biomanufacturing and is the cause of many bottlenecks. While it is an essential function in downstream processing, it does not provide added value commensurate with the level of footprint, labor and equipment investment required.
While buffer preparation itself isn’t overly complex, the volume and number of buffers required create a challenge. On average, a downstream process will use 15 unique buffers and require 5-10 liters of buffer per liter of bioreactor harvest. In addition, buffers have critical quality attributes for process performance that must be met. Considering the number and volume of buffers required for downstream processing several common pain points can be identified for traditional buffer preparation, including:
- Large amounts of classified floor space for preparation
- Significant labor requirements
- Limited facility flexibility resulting from the linear relationship between bioreactor titer and buffer volumes required
- Significant time and cost associated with quality control testing
- Excess capacity is often required to account for preparation error
While buffer preparation has not significantly changed in a number of years, with the majority of buffers prepared via powder hydration in stainless steel tanks, there has been a shift toward new methods to intensify the process and render it more space and cost efficient.
This process typically begins with companies are asking how to provide the right buffer, at the right time, and at the proper specifications, while minimizing labor and footprint.
BioContinuum™ Buffer Delivery Platform
This is precisely the question MilliporeSigma addressed when they designed the BioContinuum™ Buffer Delivery Platform. The platform provides a configurable offering of buffer concentrates, buffer dilution system, single-use assemblies, and services tailored to provide accurate and precise buffer preparation and management.
Benefits of using the BioContinuum™ Buffer Delivery Platform:
- Average of 42% CAPEX reduction
- Up to 50X dilution with <1% variability
- 18% less footprint in cleanroom
- Configurable platform can be installed and ready in 16 weeks
Sterile Filtered Buffer Concentrates
The platform provides a customizable selection of buffer concentrates available up to 50X prepared with Emprove® raw materials to enhance quality, traceability, transparency and performance. Concentrate stability data guidance is available and concentrate pre-titration eliminates post dilution pH adjustment.
Buffer Dilution System
The buffer dilution system was designed to streamline buffer preparation in a reduced facility footprint. The system enables preparation of accurate buffers from concentrates, reducing bottlenecks with additional flexibility to meet timeline, specifications, and quality standards.
The system automatically prepares accurate buffers based on volumetric flow control, utilizing Lewa Ecodos® metering pumps with Intellidrive®. This precise volumetric control minimizes process deviations, non-conforming batches and increases operational efficiency. Dilution factors up to 50:1 with variation of ≤±1.0% in accuracy and precision are supported, further reducing the required floor space.
Mobius® Select Single-Use Assemblies
Mobius select single-use assemblies can be configured to order from an optimized and pre-qualified components library based on analysis of historical assembly designs for every application. This couples off-the-shelf speed with custom flexibility. Delivery dates are available in six weeks and include comprehensive documentation for fast and easy implementation.
Comprehensive Range of Value-Added Services and Support
The BioContinuum™ Buffer Delivery Platform comes with services throughout the life of the system to ensure lower costs and time savings, which includes:
- Factory Acceptance Testing to demonstrate compliance with technical and functional specifications prior to delivery
- Site Acceptance Testing to verify that performance and functionality were not altered during transportation
- Installation Qualification and Operation Qualification to certify that all the specifications are met
- Operator training specifically designed for pharmaceutical and biotechnology manufacturing personnel
- Preventive maintenance to ensure consistent and durable performance of the system, thereby reducing the risk for costly repair and potential downtime
- Software training to help a company create proprietary recipes and manage the system. A good understanding of the software allows users to adapt to varying process characteristics during process development
To learn more about streamlining buffer management, please see BioContinuum™ Buffer Delivery Platform