Aspen Alert

Integrated Continuous Manufacturing of Therapeutic Protein Drug Substance A U.S. Patent for an "Integrated Continuous Manufacturing of Therapeutic Protein Drug Substance" was awarded to Genzyme on October 8th, 2024. The present invention is based, at least in part, on the discovery that integrated, continuous systems that include two multi-column chromatography systems can be used to continuously produce therapeutic protein drug substances. In view of this discovery, provided herein are integrated and continuous processes for manufacturing a therapeutic protein drug substance that include providing a liquid culture medium... https://lnkd.in/gx5jGmKF #aspenalert #biotech #bioprocess

Characterization of the Dynamic Viscosity of Cell Cultures and Its Effect on Mixing Performance in a Spinner Flask Bioreactor Computational fluid dynamics (CFD) models have been developed to simulate cell culturing bioreactors but assume water-like viscosity properties due to significant data gaps. This study characterized the dynamic viscosity of HEK-293 cell cultures and evaluated its effect on mixing performance in a spinner flask bioreactor. Viscosity measurements indicated that the cell culture media, media with microcarriers, and cell cultures presented shear thinning behaviors within the measured shear rate range of 1–100 s−1. The viscosity also increased with the microcarrier concentrations and growth of cell culture. The CFD model, incorporating dynamic viscosity data, showed that shear stress and Kolmogorov length profiles are significantly influenced by microcarrier concentrations and cell culture growth. https://lnkd.in/gqmsGk4i #aspenalert #biotech #bioprocess

Productive CHO Cell Lines Selection in Biopharm Process Development Through Machine Learning on Metabolomic Dynamics The identification of highly productive cell lines is crucial in the development of bioprocesses for the production of therapeutic monoclonal antibodies (mAbs). Metabolomics data provide valuable information for cell line selection and allow the study of the relationship with mAb productivity and product quality attributes. We propose a novel robust machine learning procedure which, exploiting dynamic metabolomic data from the Ambr®15 scale, supports the selection of highly productive cell lines during biopharmaceutical bioprocess development and scale-up. The metabolomic profiles dynamics allows to identify the cell lines with high productivity, already in the early stages of experimentation, and the biomarkers that are the most related to mAb productivity, finding at the same time the key metabolic pathways for discriminating mAb productivity. https://lnkd.in/gMKtVAA3 #aspenalert #biotech #bioprocess

Fluid Transport Coupling A U.S. Patent for a "Fluid Transport Coupling" was awarded to Saint-Gobain on October 8th, 2024. The present invention is a sanitary fluid transport coupling that can include a plurality of fluid conduits, each fluid conduit having a distal end and a proximal end, a support element adapted to secure a spaced relationship between the plurality of second conduits at the distal end of the plurality of fluid conduits, and an overmolded element disposed adjacent the support element. The overmolded element can form a fitting that can form a fluid connection with another fluid conduit, fluid container, or isolated environment. https://lnkd.in/gEAeHseS #aspenalert #biotech #bioprocess

Bioprocess Strategies for Enhanced Performance in Single-Use Bioreactors for Biomolecule Synthesis: A Biokinetic Approach Single-use bioreactors (SUB) have made a significant impact on the field of bioprocessing, becoming increasingly popular for biomolecule synthesis due to their many advantages, such as minimizing contamination risks and streamlining processes. Extensive research has been conducted on the hydrodynamic conditions within single-use bioreactors, with a focus on parameters like mixing time, oxygen transfer rate, and stress levels to improve cell cultivation procedures. Several studies have demonstrated that SUB can effectively nurture various cell types, including those that generate monoclonal antibodies, yielding outcomes similar to conventional bioreactor systems, thus highlighting their adaptability and effectiveness in biomolecule processing. https://lnkd.in/g4SjfD6i #aspenalert #biotech #bioprocess

Quantitative Investigation of the Effect of Mechanical and Geometrical Factors of a Laboratory-Scale Bioreactor Using a Vibrating Agitator on Mammalian Cell Culture Indices Mammalian cell cultures in laboratories are performed in static and dynamic methods, and cell growth indices are higher in dynamic mode. In this study, a lab-scale stirred bioreactor using a vibrating disc and a suitable setup has been introduced for dynamic cell culture, which creates proper mixing at low shear stress. 15 experiments have been done by Raji cell in batch mode using Box-Behnken design to quantitatively investigate the effect of mechanical and geometrical factors of this bioreactor on cell culture indices. Three structural factors, including disc diameter, vibration amplitude, and the height of the disc placement have been selected as the main factors. Three cell growth indices including the specific growth rate, the maximum cell concentration, and productivity have been considered as biological responses. https://lnkd.in/g_7E2g5M #aspenalert #biotech #bioprocess

WuXi AppTec to Raise $500 Million for Global Expansion and Debt Refinancing China’s WuXi AppTec will raise $500 million in a convertible bond sale, according to a regulatory filing this week, a month after the U.S. House passed rules to restrict business with the firm on national security grounds. WuXi Apptec says the proceeds raised in the deal will be used to fund the biotech company’s global expansion and debt refinancing. The company reiterated it was also considering options for its cell and gene therapy manufacturing unit WuXi Advanced Therapies, which operates four laboratories and manufacturing facilities in Philadelphia. WuXi Apptec had put the business up for sale, the Financial Times reported last week. The company added that it has not entered into any binding agreements for the unit. https://lnkd.in/gJ_3s4Dm #aspenalert #biotech #bioprocess

Improving the Sustainability of Biopharmaceutical Downstream Processing Through Buffer Recycling Given the global commitment to the goals for sustainable development and the anticipated growth of the biopharmaceutical market, the consumption of large buffer volumes is expected to become problematic. To address this, we propose the introduction of buffer recycling to reduce the consumption of water and chemicals. For solvent based pharmaceutical processes, solvent recycling through re-distillation is already established, but for water-based processes, this concept is still rather unexplored.In this study, buffer recycling was implemented during the equilibration phase of Protein A chromatography for antibody purification. We have investigated the potential gains of buffer recycling and demonstrated buffer recycling in two technical implementations: buffer recycling in a batch-to-batch process and buffer recycling in a multi-column process. https://lnkd.in/gX7nJnFb #aspenalert #biotech #bioprocess

Impact of Hydromechanical Stress on CHO Cells’ Metabolism and Productivity: Insights from Shake Flask Cultivations with Online Monitoring of the Respiration Activity The hydromechanical stress is a relevant parameter for mammalian cell cultivations, especially regarding scale-up processes. It describes the mechanical forces exerted on cells in a bioreactor. The maximum local energy dissipation rate is a suitable parameter to characterize hydromechanical stress. In literature, different studies deal with the effects of hydromechanical stress on CHO cells in stirred tank reactors. However, they often focus on lethal effects. Furthermore, systematic examinations in smaller scales like shake flasks are missing. Thus, this study systematically considers the influence of hydromechanical stress on CHO DP12 cells in shake flask cultivations. By utilizing online monitoring of the oxygen transfer rate, the study simplifies and enhances the resolution of examinations. https://lnkd.in/ghRznd5a #aspenalert #biotech #bioprocess

Improving Raman-Based Models for Real-Time Monitoring the CHO Cell Culture Process with Effective Variable Selection Strategies In this study, different variable selection strategies were evaluated, and the optimal variable selection strategy was determined for monitoring the CHO cell culture process. Firstly, a wide variety of spectral regions involving the Raman fingerprinting region and the C-H stretching region were investigated. Secondly, six different variable selection algorithms were meticulously assessed. Thirdly, the combination of different variable selection algorithms was used to improve model performance and simplify the model. Finally, the monitoring of cell culture processes was implemented. The findings underscored that commonly used spectral regions could improve the model performance but could not simplify the model well. This study will be helpful for researchers to select suitable variable selection strategies for building models for the real-time monitoring of cell culture. https://lnkd.in/gDYvaEgR #aspenalert #biotech #bioprocess