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Biotechnology Facilities
Published in Terry Jacobs, Andrew A. Signore, Good Design Practices for GMP Pharmaceutical Facilities, 2016
Filtration is used in downstream processing to reduce bioburden, clarify precipitates, concentrate proteins, exchange buffers (via diafiltration), remove viruses, and terminally sterilize the bulk drug substance. Filtration unit operations work on the size exclusion principle, whereby the product protein either passes through the filter membrane into the permeate stream or is retained by the membrane in the retentate. Microfiltration, which employs membrane pore sizes ranging from 0.5 to 10 μm, will remove larger particles and allow the protein to pass through into the permeate. Downstream microfiltration is commonly used for bioburden reduction and precipitate clarification. Ultrafiltration, with membrane pores from 1 to 20 nm, is effective for product concentration and buffer exchange because most biopharmaceutical products are retained by the membrane in the retentate. These operations typically use Tangential Flow Filtration (TFF), in which the retentate stream (passing cross-flow) sweeps the ultrafiltration membrane to prevent filter fouling and increase throughput.
Validation of Process Chromatography
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
This chapter addresses validation of process chromatography, the key tool that provides today’s highly pure therapeutic proteins. Process chromatography is also used to purify and thus enhance the safety of biologicals such as plasma-derived products and vaccines. For biopharmaceuticals, three to four chromatographic steps are typically employed to remove a large variety of impurities. Each chromatographic step can usually remove multiple impurities. Together with unit operations such as centrifugation and filtration, chromatography steps are an integral part of downstream processing, taking a product from crude feedstock to a purified form suitable for safe use as a biopharmaceutical, vaccine or health care agent.
Downstream Processing
Published in Maik W. Jornitz, Filtration and Purification in the Biopharmaceutical Industry, 2019
Filtration is applied at many different stages in downstream processing, both during product isolation and purification. Filtration methods are applied widely in biomanufacturing processes because they operate at relatively low temperatures and pressures, and require no phase changes or chemical additives. Thus, these processes cause minimal denaturation, deactivation, or degradation of labile macromolecules such as proteins. Filtration methods are often subcategorized on the basis of retentate size, as summarized in Table 15.1 (Zeman and Zydney 1996).
Optimising the fermentation throughput in biomanufacturing with bleed–feed
Published in International Journal of Production Research, 2023
Yesim Koca, Tugce Martagan, Ivo Adan
Biomanufacturing operations consist of two main steps: upstream and downstream processing. Upstream processing is the first production step where living cells, such as viruses and bacteria, are grown in a controlled environment to produce the desired active ingredients. Upstream processing includes operations such as preparation of seed culture, preparation of medium, fermentation and harvest. Downstream processing refers to purification and finishing operations to meet stringent regulatory requirements on quality, storage and delivery. In this paper, we focus on upstream fermentation processes. The output obtained from fermentation varies across different drugs but it often represents biomass, protein or antibody. In the remainder of this paper, we use the term ‘biomass’ to represent the output of fermentation.
Current developments in the production of fungal biological control agents by solid-state fermentation using organic solid waste
Published in Critical Reviews in Environmental Science and Technology, 2019
Arnau Sala, Raquel Barrena, Adriana Artola, Antoni Sánchez
Downstream processing involves all the procedures followed after fermentation to separate the target product from the fermentation matrix. Harvesting strategies are needed to ensure correct separation from the substrate, which in some cases (for example, when using rice as physical support) can be difficult to dry with spores (Posada-Flórez, 2008). Post-harvesting strategies, which include formulation and drying processes, are conducted to give the final configuration to the propagules, which are the infective agent of the final product. This aim can be accomplished by a wide variety of methods such as spray drying, fluid-bed drying, air drying, seed coating, or encapsulation, among others (Mascarin & Jaronski, 2016).
An overview of cotton and polyester, and their blended waste textile valorisation to value-added products: A circular economy approach – research trends, opportunities and challenges
Published in Critical Reviews in Environmental Science and Technology, 2022
Karpagam Subramanian, Manas Kumar Sarkar, Huaimin Wang, Zi-Hao Qin, Shauhrat S. Chopra, Mushan Jin, Vinod Kumar, Chao Chen, Chi-Wing Tsang, Carol Sze Ki Lin
Downstream processing involves multistep unit operations for the recovery and purification of the target products (fibers and value-added products). The most important objective in downstream processing is to maximize product recovery while minimizing the cost of production. Recently, Lin and her research group proposed a biological method to purify the glucose-rich hydrolysate derived from the hydrolysis of the cellulose in cotton/polyester blended textile waste and to regenerate PET fiber from the recovered PET residue (Subramanian et al., 2020). The suspended solid PET residue was first separated from the hydrolysate by filtration. The glucose-rich hydrolysate was treated with activated carbon, and subsequently, the activated carbon was removed by vacuum filtration. The hydrolysate was then processed in ion exchange columns to remove the ions. The columns were cleaned with deionized water and regenerated with H2SO4 (50 w/w%) and NaOH (7 w/v%). Finally, water was evaporated off from the purified hydrolysate solution to obtain a concentrated glucose sirup. In this method, washing the columns with the remaining hydrolysate reduces glucose recovery. Overall, 75% glucose recovery was achieved, i.e. 15 g/L of glucose-rich hydrolysate was purified to obtain 60 g/L of concentrated glucose sirup using this downstream processing method. The solid PET residue filtered from the hydrolysate was re-spun to obtain a good-quality PET fiber that can be applied in the textile industry in three steps: granulation (pellet formation), solid-state polymerization (increasing the molecular weights of the pellets) and melt spinning (addition of PET bottle chips to the pellet in a ratio of 80:20) (Figure 2). Melt spinning, a closed-loop recycling strategy, is widely used because it is simple and economical (Midha & Dakuri, 2017).