Bioprocessing and Process Analysis Enhancing Biologics Production
In the fast-paced world of biotherapeutics, accelerating commercialization requires the optimization of processes through the integration of advanced analytical tools that ensure maximum quality, safety, and efficacy. The focus of bioprocess development is on refining and enhancing the production processes to meet stringent industry standards.
Bioprocessing and process analysis are the backbone of biologics production, and label-free analysis systems are powerful tools that elevate these processes. Bioprocessing involves the cultivation and manipulation of biological materials to produce biologics, such as vaccines, antibodies, and cell therapies, on a scale that meets clinical and commercial demands. The challenge lies in upscaling these processes while maintaining the quality, efficacy, and safety of the final product.
Utilizing biolayer interferometry (BLI), these systems support a wide range of applications throughout the biologics manufacturing pipeline, from early optimization stages to validation and manufacturing control. The Octet® BLI platform offers capabilities for analyzing crude, unpurified process samples, allowing researchers to analyze complex mixtures directly without the need for extensive sample preparation. This is essential for optimizing bioprocesses, as it allows scientists to monitor the analyte of interest and fine-tune production parameters with precision. It provides the data needed to ensure that the biological activity and quality of the product are preserved during scale-up. Moreover, system scalability enhances process analysis by offering high-throughput capabilities, allowing for the rapid screening of multiple samples and conditions. This accelerates the optimization process, enabling researchers to identify the most efficient and cost-effective production strategies.
Label-free biomolecular interaction analysis facilitates processes such as titer determination, host cell protein analysis, residual protein detection, sialic acid content detection, potency assay development, Fab activity assay development, and more. Discover the transformative impact of Octet® BLI systems on bioprocess development and their contribution to the successful commercialization of biotherapeutics.
Bioprocess Development: Benefits and Challenges
Advantages
Scalability: Bioprocess development enables the scaling up of production from laboratory to industrial scale, ensuring that sufficient quantities of the drug can be produced to meet demand.
Cost Efficiency: Optimizing bioprocesses can lead to more cost-effective production methods, reducing the overall cost of drug manufacturing and making treatments more affordable.
Quality Control: The development of robust bioprocesses ensures consistent product quality and compliance with regulatory standards, which is crucial for patient safety and efficacy.
Innovation in Production: Advances in bioprocess development can lead to innovative production techniques, such as continuous processing, which can improve efficiency and reduce production times.
Challenges
Complex Biological Systems: Bioprocess development involves complex biological systems that can be difficult to control and optimize, requiring specialized knowledge and expertise.
Regulatory Compliance: Ensuring compliance with stringent regulatory requirements can be challenging, as bioprocesses must meet high standards for safety, efficacy, and quality.
High Initial Investment: The development and optimization of bioprocesses require significant initial investment in technology, infrastructure, and skilled personnel.
Process Variability: Biological systems are inherently variable, and maintaining consistency in production can be challenging, requiring robust process control, and monitoring systems.
Featured Applications
Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics
The high cost and lengthy times associated with drug discovery and development have forced biopharm companies to improve the efficiency and economics. Biopharmaceutical companies have enthusiastically adopted Octet® BLI systems due to their broad utility in protein quantitation and functional characterization combined with enhanced throughput, decreased sample preparation requirements, and low cost of operation.
Mab Quantitation: Protein A HPLC vs. Protein A Bio-Layer Interferometry
Rapid, accurate and cost-effective quantitation of monoclonal antibodies (MAbs) is essential for bioprocessing. Here we assess the relative merits of Protein A High-Pressure Liquid Chromatography (HPLC) and Protein A bio-layer interferometry BLI using an eight-channel Octet® R8 systems to determine mAb concentration in a complex feedstock.
A Rapid Method to Quantitatively Screen Bispecific Antibody using Protein A and His1K Biosensors Bispecific
Scientists at Celgene Corporation developed a screening process incorporating the Octet® BLI platform. This allows them to identify pools and clones with higher concentrations of bispecific antibodies. High throughput was achieved from the multiple simultaneous measures possible on one system and rapid assays times, such as binding optimization in only 10 minutes.
