Yokogawa Fluence Analytics’ Post

⚙️🔬 High-Throughput Raman Spectroscopy in Biopharmaceutical Process Development 📉🧬 Raman spectroscopy offers a promising avenue for advancements in biopharmaceutical process development, addressing both upstream and downstream operations. Despite its potential, the widespread implementation has faced challenges due to the costs of probes and the difficulty in analyzing low sample volumes. 🔍This study by Stephen Goldrick, Alexandra Umprecht, Alison Tang, Roman Zakrzewski, Matthew Cheeks PhD, MBA, Richard Turner OBE, Aled Charles, Karolina Les, Martyn Hulley, Chris Spencer PhD and Suzanne Farid introduces a high-throughput (HT) Raman spectroscopy microscope combined with a novel data analysis workflow, aiming to offer a more efficient alternative to traditional off-line analytics. Key Insights: 🔄 Upstream Efficiency: Successful prediction of key parameters such as glucose, lactate, antibody, and viable cell density concentrations, enhancing monitoring efficiency. 🧪 Downstream Application: The HT Raman device was used in developing a cation exchange chromatography step, accurately predicting monomer purity and concentration and aiding in sample classification. 💡 Cost-Effective Solution: The microscope's ability to work with small sample volumes and replace multiple analytical devices makes it a cost-effective option for comprehensive bioprocess development. 📊 Data Analysis: The data analysis workflow, including PLS modeling, offers robust predictions for certain metrics, although it finds challenges in accurately predicting low molecular weight species. 🔗 Link to Publication: https://lnkd.in/gvGtwqzM #Biopharmaceuticals #RamanSpectroscopy #ProcessDevelopment #InnovativeTechnology #DataAnalysis #Bioprocessing #PolyModelsHub

Join this webinar to hear how A-TEEM spectroscopy bridges the gaps in sensitivity and selectivity left by other analytical tools. #biopharma #mAB #proteins #cellmedia #proteintherapeutics

The recent advancements in multivariate data analysis on multisensor measurements for inline process monitoring, particularly in adenovirus production in HEK293 cells, present significant strides in biomanufacturing. The integration of various sensors, including dual-wavelength fluorescence spectroscopy and dielectric signals, alongside traditional critical process parameters (CPPs) like oxygen uptake rate and pH, provides a nuanced and comprehensive view of the bioprocess. This system has demonstrated the ability to monitor and predict critical quality attributes with high accuracy, which is pivotal for maintaining the robustness and efficiency of production processes. Significantly, this approach underscores the potential of multisensor data fusion in enhancing process analytical technology (PAT) applications. By leveraging data from multiple sources through advanced statistical methods like multivariate data analysis, manufacturers can achieve more accurate real-time monitoring and control. This is particularly critical in the production of viral vectors, where precise control of bioprocess parameters can directly influence the quality and yield of the final product. The predictive performance of models developed from these integrated data sources, which outperforms traditional single-sensor models, indicates a promising direction for future biopharmaceutical manufacturing technologies. This could pave the way for more sophisticated and finely-tuned bioprocesses that ensure higher product quality and process efficiency. How might these technological advancements influence regulatory standards and quality assurance practices in biopharmaceutical manufacturing in the coming years? https://lnkd.in/gtXXWh9G #Biopharmaceuticals #ManufacturingInnovation #QualityAssurance

Here Griffiths et al examins the addation of Cyclic Ion Mobility to hydrogen/deuterium exchange mass spectrometry workflows. 🎯Summary: Griffiths et al observed the addation of single and multi pass cyclic ion mobility resulted in observed peptide out put been 31 to 222% higher than previous generation SYNAPT G2-Si instrumentation. #massspectrometry #massspec #chemistry #science #biopharmaceutical #anytical #lcms #mabs #scienceandtechnology ##biotech #pharmaceutical #mabs https://lnkd.in/eV4MCDHF

Mass flow controllers play a pivotal role in maintaining a controlled environment within #bioreactors for #biopharmaceutical manufacturing. The complexities associated with developing new drugs and gene-based therapies demand sophisticated manufacturing processes. Biopharmaceuticals, derived from biological sources like organs and tissues, require cutting-edge bioreactors to cultivate highly sensitive botanical and mammalian cell cultures in a stable, precisely controlled growth environment. #BrooksInstrument's SLA Series mass flow controllers have been at the forefront of #BioprocessingControl for years, offering superior long-term stability and industry-leading mean-time-between-failures (MTBF). These controllers are renowned as an industry standard in life #sciences applications. Engineered to address key industry challenges, the SLA Series Biotech MFC models boast features tailored for equipment manufacturers and end-users alike. With high turndown ratios, extremely low leak rates, pre-calibrated multi-gas capabilities, and premium versions meeting emerging regulatory requirements, they offer unparalleled performance and reliability in bioprocessing systems. Explore how Brooks Instrument's SLA Series Biotech MFCs are revolutionizing gas flow control in bioprocessing, providing enhanced efficiency, cost-effectiveness, and regulatory compliance for the biopharmaceutical industry. Read the full article here: https://lnkd.in/dQnFpBBM

#Bioprocess_Analyzers Market Key Players Analysis and Forecast To 2032 by Value Market Research >> https://lnkd.in/gBwSt4SB #Bioprocess Analyzers are #instruments used in biotechnology and pharmaceutical #manufacturing to monitor and #control the various stages of #bioprocessing, such as #fermentation and cell culture. These #analyzers assess critical #parameters like nutrient levels, #metabolites, and cell viability, providing real-time #data to optimize #bioproduction processes. Nova Biomedical Sartorius F. Hoffmann-La Roche Ltd Sysbiotech Kaiser Optical Systems SARL YSI, a Xylem brand RANDOX LABORATORIES LIMITED #medicaldevices #bioprocessanalyzers #biopharmaceuticals #biotechnology #manufacturing

An exciting new research evaluates the use of process analytical technology (PAT) tools in perfusion cultures, including the innovative time-gated Raman technology! Key highlights: 🔍 PAT tools, such as PicoRaman M3, are essential to the application of continuous manufacturing in the pharmaceutical industry by enabling the application of automatic feedback control strategies to regulate bioprocesses’ critical process parameters (CPPs) and product quality 🔍 Timegated® Raman data can be used to build predictive statistical models, thus enabling the real-time monitoring of key cultivation parameters 🔍 High variability dataset produces more robust predictive models for enhancing reliability Discover more about the research advancing pharmaceutical manufacturing conducted by Kungliga Tekniska högskolan researcher Fernanda Rebellato Giordano Martim: https://hubs.ly/Q02D-GSf0. #timegating #processmonitoring #research #PAT

𝐏𝐫𝐨𝐭𝐞𝐢𝐧 𝐏𝐮𝐫𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐈𝐬𝐨𝐥𝐚𝐭𝐢𝐨𝐧: Growth, Demand and Future Opportunities Protein purification is a process that isolates and purifies a single protein or protein complex from tissues, cells, or entire organisms. This process is essential for determining the cells' function, structure, and interactions of a protein of interest. Protein isolation helps understand the protein’s size, biological activity, binding affinity, protein-protein interaction, and physiochemical properties. #Proteinpurification and isolation are done using various technologies such as precipitation, ultrafiltration, chromatography, and electrophoresis. 𝑮𝒓𝒂𝒃 𝒕𝒉𝒆 𝑷𝑫𝑭 𝑩𝒓𝒐𝒄𝒉𝒖𝒓𝒆 𝑵𝒐𝒘 @ https://lnkd.in/eGcQxFT8 Furthermore, the growing need to identify new protein-based drug molecules, rising research in pharmaceutical and biopharmaceutical fields, and increasing focus on precision medicine are the factors driving the growth of the protein purification and isolation market. In addition, the increasing demand for protein therapeutics and rising spending on R&D in pharmaceutical and biotechnology industries are creating opportunities for the growth of this market. 𝑶𝒑𝒑𝒐𝒓𝒕𝒖𝒏𝒊𝒕𝒊𝒆𝒔: 1. Rising Research in Precision Medicine 2. Rising Government Spending on R&D in Pharmaceutical and Biotechnology 𝑩𝒚 𝑻𝒆𝒄𝒉𝒏𝒊𝒒𝒖𝒆: 1. Ultrafiltration 2. Precipitation 3. Chromatography 4. Electrophoresis 5. Western Blotting (Immunoblotting) 6. Dialysis and Diafiltration 7. Centrifugation 𝑹𝒆𝒂𝒅 𝑶𝒖𝒓 𝑳𝒂𝒕𝒆𝒔𝒕 𝑵𝒆𝒘𝒔 @ https://lnkd.in/eVrg9a7e #chromatography #ultrafiltration #precipitation #electrophoresis #drugscreening #proteinisolation #targetidentification #cro #laboratory #laboratoryequipment #analyticalinstruments #pharmaceuticals #pharmaindustry #biotechnology #biotech #clinicalresearch #research

Report on some proof of concept work looking at using a novel attenuated total reflection Fourier transform infrared (ATR-FTIR) spectroscopy platform, with disposable internal reflection elements (IREs), for monitoring an upstream bioprocess. #bioprocessing #cellculture #ATRFTIR #PAT #biopharmaceuticals #biotherapeutics https://lnkd.in/emgV7jcm

What are the key challenges in scaling up LNP production from lab scale to commercial scale? Scaling up the production of lipid nanoparticles (LNPs) from lab scale to commercial scale presents several significant challenges that must be addressed to ensure product consistency and regulatory compliance. One of the primary challenges is maintaining the uniformity and quality of the LNPs when transitioning from small-batch production to large-scale manufacturing. Factors such as particle size distribution, encapsulation efficiency, and stability must be closely monitored and controlled to ensure that the properties of the LNPs produced at a larger scale match those produced at the lab scale. Another major challenge is the scalability of the manufacturing equipment and processes. Equipment that is suitable for lab-scale production may not be directly scalable, necessitating the development or adaptation of new technologies that can handle larger volumes while maintaining the critical process parameters. Microfluidic mixing, which is effective at the lab scale, must be adapted for high-throughput production, requiring significant engineering expertise and process validation. Additionally, the solvent recovery and recycling processes must be optimized to minimize waste and reduce costs at a commercial scale. Regulatory compliance is also a critical consideration during scale-up. The manufacturing process must adhere to Good Manufacturing Practice (GMP) guidelines, which require rigorous documentation and validation of all steps involved in the production process. This includes the validation of the scalability of the process, ensuring that the quality attributes of the LNPs, such as particle size, zeta potential, and drug loading, are consistent across all production batches. Addressing these challenges is essential for the successful commercialization of LNP-based therapeutics, ensuring that they meet the required standards for safety, efficacy, and quality. #LNPProduction #NanoparticleManufacturing #LabToCommercialScale #PharmaceuticalManufacturing #GMPCompliance #LipidNanoparticles #DrugDelivery #PharmaScaleUp #Nanotechnology #ParticleSizeControl #EncapsulationEfficiency #ProcessValidation #Microfluidics #HighThroughputProduction #BiopharmaManufacturing #ProcessOptimization #SolventRecovery #RegulatoryCompliance #QualityAssurance #DrugDevelopment #TherapeuticNanoparticles #EngineeringChallenges #PharmaInnovation #ProcessScaleUp #Nanomedicine #PharmaProcessEngineering #ManufacturingTechnology #LNPFormulation #Biopharmaceuticals #PharmaScaleUpChallenges https://lnkd.in/g4vrSBHM