Test & measurement
SENSORS TAILORED TO INDUSTRY STANDARDS
The specificity of Raman spectra allows the identification of application-specific molecules, making it an optimal tool for many bioprocess applications. Leading bioprocess probes are designed with industry-specific requirements in mind, including strict material standards, various sterilisation methodologies, port compatibility and convenience. Industry-approved wetted materials offer compatibility with standard cleaning and sterilisation protocols, ensuring consistent performance across different bioreactor setups. Ideally, core probe technology should be consistent across all scales and types of bioreactors to facilitate seamless integration into existing and future systems. This consistency enables easy adaptation to traditional and single-use bioreactors, in batch or continuous mode, and from process development to cGMP manufacturing.
SINGLE-USE VS. MULTI-USE BIOPROCESSING
The current landscape of biopharmaceutical operations involves a mix of single-use and multi-use vessels, instrumentation and sensors. Single-use systems, designed for one batch or a manufacturing cycle before replacement, are in high demand across the life sciences industry. Single-use bioprocessing setups are known for their flexibility, allowing easy movement, removal or expansion based on production demand. They eliminate the need for additional cleaning, sterilisation and component validation, offering opportunities for reduced material use, costs, cross-contamination risks and manufacturing times. On the other hand, multi-use bioreactors, made of glass or stainless steel, provide more permanent setups, typically built to specified capacities and processing needs. Raman spectroscopy has a role to play in both scenarios, adapting to the industry’s transition from batch to continuous processing and from multi-use
to single-use systems. As the industry grapples with these shifts, reliable in-line Raman spectroscopy- based measurement methods become imperative. The next generation of single-use technology in bioprocessing is witnessing enhancements to make these systems more user-friendly, efficient and suitable for fully continuous operation.
STANDALONE DEVICES VS. COMPREHENSIVE LAB-TO-PROCESS RAMAN SYSTEMS
While standalone Raman analysers and probes can provide useful data, ultimate efficiency in biopharmaceutical processes requires comprehensive Raman systems with lab-to- process scalability. These systems should comprise robust analysers, optimised bioprocessing probes, simple calibration and verification routines, method transfer technology and embedded automation protocols.
Endress+Hauser, a pioneer in the field, has been at the forefront of Raman technology in the life sciences industry for over 30 years. The company continuously expands its Raman system portfolio to address the analytical challenges faced by biopharmaceutical companies. Its offerings include specialised Raman probes and optics designed for micro and mini bioreactors, traditional or single-use systems, flow paths, and batch or continuous processes, as well as robust analysers optimised for scalability from lab to manufacturing environments. New easy-to-use calibration and verification technology is now offered to round out the company’s Raman system product line.
RAMAN INTERFACE TO HIGH- THROUGHPUT DEVELOPMENT Recent advances have expanded Raman analysis to the smallest bioreactor setups and
Instrumentation Monthly February 2025
large-scale single-use bioreactors (SUBs). One such innovation is the union between Endress+Hauser Raman analysers equipped with Rxn-46 bioprocess probe technology and the BioPAT Spectro platform by Sartorius. This integrated solution offers an ideal interface to high-throughput development through single-use clinical and commercial manufacturing. The Rxn-46 probe, adapted to fit Sartorius’s BioPAT Spectro platform , utilises the same probe design for Ambr 15, Ambr 250 and Biostat STR bioreactors . The integration allows for the rapid generation of Raman data to build robust, scalable models. Providing fast, reliable and accurate measurement of key bioprocess variables has never been easier.
INTEGRATION INTO SINGLE-USE SYSTEMS
Another recent revolution is the ability to offer Raman technology pre-installed into single-use bioreactor and mixing bags. Integrated single-use Raman probe connections eliminate contamination risks associated with end-user probe sterilisation and aseptic insertion. Endress+Hauser stands out by offering one of the only multi-attribute sensors available for different types of bioprocessing containers and from multiple single-use vendors.
The Raman optic system for single use comprises a disposable fitting and a reusable non-contact optic. The disposable wetted part aligns with industry standards and is sold directly to single-use vendors. There, it undergoes gamma sterilisation and is delivered as a sterile, ready-to-use component of the SUB or mixing bag. This approach enhances ease of use, reduces cleaning and maintenance requirements, and minimises contamination risk without compromising performance.
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