Aspen Alert

Experimental Determination of Maximum Shear Stress in Mobius® Breez Perfusion Microbioreactors and Comparative Analysis with Stirred Tank Bioreactors The Mobius® Breez microbioreactor offers a significant reduction in experimental effort by downsizing the classical volume of perfusion bioreactors to the mL range and thus represents a valuable tool for process development. However, miniaturization has raised questions regarding comparability with traditional bioreactors in terms of the physical environment, such as hydrodynamic shear stress. Therefore, the maximum hydrodynamic shear stress, cultivation performance, and membrane-wall contact were evaluated to elucidate the system's behavior. Findings reveal two distinct operational conditions, distinguished by the presence or absence of membrane-wall contact, resulting in varying levels of hydrodynamic stress. https://lnkd.in/gSrY8t2r #aspenalert #biotech #bioprocess

Avid Bioservices Acquired for $1.1 Billion in Cash Avid Bioservices, a CDMO specializing in biologic drugs, is going private in an M&A deal that values the company at $1.1 billion. The buyers are two private equity firms, GHO Capital Partners and Ampersand Capital Partners. Tustin, California-based Avid was the CDMO subsidiary of the former Peregrine Pharmaceuticals, a developer of antibody drugs for cancer. In 2018, Peregrine decided to end its drug R&D and focus the business on CDMO work under the Avid Bioservices name. Its customers include biotech and pharmaceutical companies in the early stages of development all the way through to commercialization. GHO and Ampersand each already have CDMOs in their portfolios, and the two firms have previously struck CDMO deals with each other. https://lnkd.in/gq6iK9iz #aspenalert #biotech #bioprocess

Enhancing Cryopreservation of Human iPSCs: Bottom-Up vs Conventional Freezing Geometry To provide quality-controlled iPSCs for clinical therapies, it is essential to develop safe cryopreservation protocols for long-term storage, preferable amenable for scale-up and automation. We have compared the impact of two different freezing geometries (bottom-up and conventional radial freezing) on the viability and differentiation capability of human iPSCs. Our results demonstrate that the bottom-up freezing under optimized conditions significantly increases iPSCs viability, up to 9% for the cell membrane integrity and up to 21% for the cell metabolic state, compared to conventional freezing. The improvement achieved for bottom-up versus conventional freezing was maintained after scale-up from cryogenic vials to 30 mL bags, highlighting the method’s potential for clinical applications. These findings show that bottom-up freezing can offer a more controlled and scalable cryopreservation strategy for iPSCs, promoting their future use in regenerative medicine. https://lnkd.in/gmxyAD-R #aspenalert #biotech #bioprocess

NMR Coupled with Multivariate Data Analysis for Monitoring the Degradation of a Formulated Therapeutic Monoclonal Antibody The function of a protein is directly coupled to its higher-order structure (HOS). Deviations in this critical quality attribute (CQA) may be linked to a decrease in the efficacy and/or safety of the final therapeutic product. High-resolution nuclear magnetic resonance (NMR) spectroscopy has been recently highlighted for protein HOS characterization, thanks to its ability to capture small changes at the molecular and structural levels (primary, secondary, tertiary and quaternary). The present study was carried out to demonstrate the ability of NMR (1D 1H and 2D 1H-13C experiments) coupled with multivariate data analysis (PCA and PLS regression) to monitor the degradation of a formulated mAb-like protein and for the simultaneous quantification of related CQAs, i.e., potency, purity and impurities (aggregates and fragments). The results indicate that this approach could be applied to mitigate product quality risks during development, manufacturing and stability studies of mAb therapeutics. https://lnkd.in/gZhF6uwm #aspenalert #biotech #bioprocess

Novo Nordisk Discards Kidney Disease Drug from $1.3 Billion Deal in Wake of Phase 3 Fail Novo Nordisk, after mulling the implications of a phase 3 fail, has given up on a late-stage kidney drug acquired in a $1.3 billion deal. The Danish biopharma bought the nonsteroidal mineralocorticoid receptor antagonist, called ocedurenone, from KBP Biosciences a year ago. The thinking was that the drug could be a possible rival to Bayer’s approved chronic kidney disease (CKD) drug Kerendia. But those ambitions went up in flames in July when a prespecified interim analysis of a phase 3 trial in hypertension and advanced CKD showed the trial had missed its primary endpoint of triggering a significant change in systolic blood pressure, leading Novo to halt the study. After analyzing “detailed trial data,” Novo has now decided to terminate the program completely, it confirmed in its third-quarter earnings release this week. https://lnkd.in/gFMrwwbJ #aspenalert #biotech #bioprocess

Optimizing cGMP Facility Design Space with a Hybrid Approach Thursday, November 14th, 2024 Modular and prefabricated construction approaches have continued to gain recognition across multiple industries for the benefits they can bring to the quality, delivery, and flexibility of a new manufacturing facility. While there can be projects that benefit from a single approach entirely, the optimum solution for most new facility projects is "hybrid", or combination, of different options integrated into a project delivery approach that exceeds client expectations and provides the highest value through the facility lifecycle. This approach is being adopted and successfully implemented by both manufacturers and CDMOs in the biopharma industry. The benefits of "hybrid" design will be discussed, and a real project case study will be presented to demonstrate the effectiveness of the approach. https://lnkd.in/gGE4qnRB #aspenalert #biotech #bioprocess

Fujifilm Diosynth Biotechnologies Launches First Phase of Expansion in Denmark Fujifilm Diosynth Biotechnologies has launched the first phase of its expansion at the Hillerød, Denmark site, bringing the new production capacity into operation. This milestone marks the initial step in the company’s strategy to build a comprehensive global ecosystem dedicated to enhancing the production and delivery of life-saving medicines. This first phase adds six mammalian cell bioreactors, bringing the total capacity at the Hillerød site to 12 x 20,000 L bioreactors. A previously announced major capital investment will support the next phase, which will include an additional 8 x 20,000 L bioreactors and two downstream processing streams. By mid-2025, fill/finish production is scheduled to commence, with full expansion expected to be in operation by 2026, increasing the site footprint to approximately 555,000 sq. ft. and creating up to 2,200 jobs. https://lnkd.in/gHsufpjn #aspenalert #biotech #bioprocess

Serum-Free Medium for Recombinant Protein Expression in Insect Cells The baculovirus expression vector system (BEVS) has been widely used to produce recombinant proteins because of several advantages, such as eukaryotic post-translational modifications similar to those in mammalian cells, high expression levels and safety, and large gene capacity. Usually, insect cell culture requires 5%‒10% fetal bovine serum, which has many adverse effects, including high cost, heterogeneity between batches, complex composition, and pollution risks. Therefore, serum-free medium (SFM) is indispensable for the production of recombinant proteins in insect cell culture. Here, the most commonly used insect cell lines and three insect cell media, namely basic medium, SFM, and chemically defined medium, are summarized. https://lnkd.in/g2avwDP7 #aspenalert #biotech #bioprocess

Cloud-Connected Bioreactors: Optimizing Synthetic Biology Scale-Up Tuesday, November 12, 2024 While synthetic biology has considerably advanced in the past decade, cost continues to be a major factor in commercial viability. Saccharomyces cerevisiae is a commonly used microbial host in synthetic biology. In this webinar, the expert speakers demonstrate the seamless scale-up of a high-yield fermentation process from 250 mL to 5 L, enabled by extensive vessel characterization using cloud-connected bioreactors. The speakers will share insights into how utilizing S. cerevisiae provided an efficient and cost-effective scale-up method. They will also present case studies that illustrate the steps taken to reduce costs and mitigate risks during the scale-up process. Register for this webinar to discover how cloud-connected bioreactors are revolutionizing the scale-up process for biomanufacturing. https://lnkd.in/gXx7wTbM #aspenalert #biotech #bioprocess

Beyond Viability: Advancing CHO Cell Culture Process Strategies to Modulate Host Cell Protein Levels While purification strategies usually offer substantial HCP clearance, certain problematic HCPs, particularly lipases, pose significant challenges. This study investigates the accumulation of various problematic HCPs in CHO cell culture using transcriptomics, revealing correlations between cell culture parameters and HCP activity. Contrary to conventional assumptions, viability alone does not reliably predict HCP levels, with factors such as clone selection, host cell line choice, and media feed type significantly influencing HCP accumulation. Leveraging transcriptomics-based approaches, we demonstrate the potential of upstream process control strategies to mitigate HCP presence and improve biologic product quality. Our findings underscore the importance of considering diverse cell culture parameters in bioprocess optimization to ensure product stability and quality. https://lnkd.in/g27Z3pc3 #aspenalert #biotech #bioprocess