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Order Articulavirales
Published in Paul Pumpens, Peter Pushko, Philippe Le Mercier, Virus-Like Particles, 2022
Paul Pumpens, Peter Pushko, Philippe Le Mercier
For purification of influenza VLPs, a nitrocellulose membrane-based filtration system (Park and Song 2017) and a cascade of ultrafiltration and diafiltration steps, followed by a sterile filtration step (Geisler and Jarvis 2018; Carvalho et al. 2019), were used successfully. The bioprocessing of influenza VLPs was recently reviewed (Durous et al. 2019).
Bioprocessing of Microalgae for the Production of Value Compounds
Published in Gokare A. Ravishankar, Ranga Rao Ambati, Handbook of Algal Technologies and Phytochemicals, 2019
Giorgos Markou, Christina Ν. Economou, Imene Chentir
Microalgae have significantly gained interest due to their potential as a new source of bio-based products. Bioprocessing of microalgae can lead to the accumulation of target metabolites, such as lipids, carbohydrates, pigments, etc. Bioprocess strategies for this purpose include nutrient starvation/limitation or subjecting cells to salinity stress or any other cultivation condition (light, temperature, etc.) that could act as stimulus. However, in most cases there is a trade-off between accumulation of target compounds and growth rates. Microalgal high-value products have good perspectives to form a market niche, and therefore there are research and engineering opportunities towards developing optimized cultivation systems for enhanced production of microalgal high-value products.
Engineering the Plant Cell Factory for Artemisinin Production
Published in Tariq Aftab, M. Naeem, M. Masroor, A. Khan, Artemisia annua, 2017
Mauji Ram, Himanshu Misra, Ashish Bharillya, Dharam Chand Jain
The Bill and Melinda Gates Foundation awarded a five-year grant of $42.6 million in December 2004 to the Institute for One World Health and a non-profit pharmaceutical company (Amyris Biotechnologies), to fund the research and development partnership between Amyris and the University of California Berkeley (U.C. Berkeley). The research used synthetic biology to develop a stable and scalable, low-cost technology platform for producing artemisinin and its derivatives. The goal of the collaboration is to create a consistent, high-quality, and affordable new source of artemisinin, a key ingredient for making the life-saving antimalarial drugs known as ACTs. In this case, the project team is using synthetic biology to insert genes from the plant A. annua L. into E. coli , a bacterium. Professor Jay Keasling’ s laboratory in the Centre for Synthetic Biology at U.C. Berkeley has completed the synthetic biological process to produce artemisinic acid, a precursor to artemisinin (Figure 11.4). In another study, attempts have been made to use S. cerevisiae to produce artemisinin precursors. The expression of the ADS gene in yeast using plasmids and chromosomal integration led to the production of 600 and 100 μ g L− 1 amorpha-4,11-diene, after 16 days of batch cultivation (Lindahl et al., 2006). Ro et al. (2006) have reported the production of 100 mg/L artemisinic acid in a S. cerevisiae strain containing an engineered MVA pathway coupled with the genes encoding ADS and CYP71AV1. This strain transported artemisinic acid, the artemisinin precursor, outside the yeast cell, which makes purification of the product less complex. Paddon et al. (2013) provided a major breakthrough using strains of S. cerevisiae (baker’ s yeast) and achieved up to 25 g/L of artemisinic acid with fermentation and also achieved 40%– 45% conversion rate of artemisinic acid into artemisinin. Artemisinic acid can be used for the semi-synthesis of artemisinin, but to lower the cost of production of the drug, bioprocessing must be optimized (Liu et al., 1998b).
Purposing plant-derived exosomes-like nanovesicles for drug delivery: patents and literature review
Published in Expert Opinion on Therapeutic Patents, 2023
Nicola Salvatore Orefice, Rossella Di Raimo, Davide Mizzoni, Mariantonia Logozzi, Stefano Fais
Many medical conditions can be cured if the current medical systems work synchronously through integrated approaches. Natural products are the base of novel therapeutic compounds and pose minimum adverse effects. Recent advances in the PDENs have gained impetus; however, several safety and regulatory requirements must be satisfied before pharmaceutical manufacturing and novel supportive therapeutic strategies can be realized. Given the infancy of the PDEN -based therapeutics, there are understandably no assays for safety testing and limited information about localization and biodistribution profiles. The safety of the source from which the PDENs are derived must also be considered. Given the similarities with the biopharmaceutical properties of fruits, significant learning can be applied from the organic agriculture sector. From a clinical perspective, a successful clinical translation of PDENs requires further standardization and addressing some of the significant challenges associated with their reproducible manufacture. However, as with the cell therapy field, considerable emphasis must be placed on understanding the fundamental of PDENs to begin addressing some of the standardization and manufacturing challenges. This also involves understanding the scalable production of the source as well as the fundamental bioprocessing conditions required to enable the reproducible production and purification of therapeutically relevant PDENs.
Harnessing the potential of machine learning for advancing “Quality by Design” in biomanufacturing
Published in mAbs, 2022
Ian Walsh, Matthew Myint, Terry Nguyen-Khuong, Ying Swan Ho, Say Kong Ng, Meiyappan Lakshmanan
While ML models offer potential over conventional MVDA in identifying significant CPPs within an allowable range that affect CQAs with good accuracy, one notable limitation is the large data requirement for a model to be well-trained and able to produce desirable predictions on unseen data. Generation of large amounts of biomanufacturing data is highly challenging, as each bioprocessing campaign is quite expensive. Companies must invest in automated samplers, digitization, and high-throughput technologies to generate large amounts of data with minimal human effort. Moreover, substantial resources and investment are required to store the historical data in an organized manner so that it can be both expanded and continuously used to improve the model predictions successively. In order to achieve this goal, pharmaceutical companies are now investing in both digitization technologies and big data management services such as cloud data storage and Internet of Things (IoT).66 While investing in data accumulation over a period of time can reap benefits for individual players, establishing a consortium among both public and private biomanufacturing data generators could accelerate the pace at which data are generated and could benefit the wider community. Such efforts require the pharmaceutical companies to work together while still protecting their sensitive information. Academia must also play a role to release datasets for the public to use freely.
Stability of a high-concentration monoclonal antibody solution produced by liquid–liquid phase separation
Published in mAbs, 2021
Jack E. Bramham, Stephanie A. Davies, Adrian Podmore, Alexander P. Golovanov
Due to its spontaneous and self-driven nature, it may be tempting to incorporate LLPS in bioprocessing pipelines as a means of concentrating biopharmaceutical mAbs. To achieve that conditions under which LLPS occurs must first be identified for each individual mAb. While the primary sequence of some mAbs may render them inherently more prone to self-association and LLPS,25,38 a wide variety of additives, such as salts, macromolecular crowders and polyvalent ions,39–41 can be used alongside temperature and pH to induce LLPS. Selection of these additives and conditions could be achieved using conventional high-throughput screening platforms, for example, through detection of opalescence by light scattering techniques. To recover the favorable properties of solutions concentrated by LLPS, conventional formulation screening42,43 could be used to establish which excipients should be added to the separated dense fraction to prevent further phase separation, reduce self-association and solution viscosity, and achieve long-term storage stability. The practical issues regarding the scalability of this approach to the larger volumes necessary during industrial-scale bioprocessing require further investigation, and most likely would be mAb- and process-dependent. We suggest that in some cases concentrating biopharmaceutical proteins by LLPS may be more efficient than tangential flow ultrafiltration, given the cost of materials, energy and issues with membrane fouling.