Process Development and Scale-Up of a PPARγ Agonist: Selection of the Manufacture Route

2009 ◽  
Vol 13 (2) ◽  
pp. 303-309 ◽  
Author(s):  
Kae M. Bullock ◽  
Delphilia Burton ◽  
John Corona ◽  
Ann Diederich ◽  
Bobby Glover ◽  
...  
Keyword(s):  
Process Development ◽  
Scale Up ◽  
Pparγ Agonist ◽  
Selection Of

scholarly journals Process Development and Scale-up Optimization of the SARS-CoV-2 Receptor Binding Domain-Based Vaccine Candidate, RBD219-N1C1

2020 ◽  
Author(s):  
Jungsoon Lee ◽  
Zhuyun Liu ◽  
Wen-Hsiang Chen ◽  
Junfei Wei ◽  
Rakhi Kundu ◽  
...  
Keyword(s):  
Receptor Binding ◽  
Process Development ◽  
Low Cost ◽  
Scale Up ◽  
Neutralizing Antibody ◽  
Protein Antigen ◽  
Purification Process ◽  
Good Manufacturing Practices ◽  
Purification Methods ◽  
Selection Of

AbstractA SARS-CoV-2 RBD219-N1C1 (RBD219-N1C1) recombinant protein antigen formulated on Alhydrogel® has recently been shown to elicit a robust neutralizing antibody response against SARS-CoV-2 pseudovirus in mice. The antigen has been produced under current good manufacturing practices (cGMP) and is now in clinical testing. Here, we report on process development and scale-up optimization for upstream fermentation and downstream purification of the antigen. This includes production at the 1 and 5 L scale in the yeast, Pichia pastoris, and the comparison of three different chromatographic purification methods. This culminated in the selection of a process to produce RBD219-N1C1 with a yield of >400 mg per liter of fermentation with >92% purity and >39% target product recovery after purification. In addition, we show the results from analytical studies, including SEC-HPLC, DLS, and an ACE2 receptor binding assay that were performed to characterize the purified proteins to select the best purification process. Finally, we propose an optimized upstream fermentation and downstream purification process that generates quality RBD219-N1C1 protein antigen and is fully scalable at a low cost.

scholarly journals Scaling-up production of plant endophytes in bioreactors: concepts, challenges and perspectives

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Seedhabadee Ganeshan ◽  
Seon Hwa Kim ◽  
Vladimir Vujanovic
Keyword(s):  
Crop Production ◽  
Process Development ◽  
Hazard Analysis ◽  
Scale Up ◽  
Process Technology ◽  
Lack Of Information ◽  
Agriculture Industry ◽  
Start Up ◽  
Plant Growth Promoting ◽  
Agriculture And Food

AbstractThe benefit of microorganisms to humans, animals, insects and plants is increasingly recognized, with intensified microbial endophytes research indicative of this realization. In the agriculture industry, the benefits are tremendous to move towards sustainable crop production and minimize or circumvent the use of chemical fertilizers and pesticides. The research leading to the identification of potential plant endophytes is long and arduous and for many researchers the challenge is ultimately in scale-up production. While many of the larger agriculture and food industries have their own scale-up and manufacturing facilities, for many in academia and start-up companies the next steps towards production have been a stumbling block due to lack of information and understanding of the processes involved in scale-up fermentation. This review provides an overview of the fermentation process from shake flask cultures to scale-up and the manufacturing steps involved such as process development optimization (PDO), process hazard analysis (PHA), pre-, in- and post-production (PIP) challenges and finally the preparation of a technology transfer package (TTP) to transition the PDO to manufacturing. The focus is on submerged liquid fermentation (SLF) and plant endophytes production by providing original examples of fungal and bacterial endophytes, plant growth promoting Penicillium sp. and Streptomyces sp. bioinoculants, respectively. We also discuss the concepts, challenges and future perspectives of the scale-up microbial endophyte process technology based on the industrial and biosafety research platform for advancing a massive production of next-generation biologicals in bioreactors.

Process Development and Scale-up of T3-Sulfate, A New Prodrug Alternative to the Conventional Hormone Therapy of Hypothyroidism

2014 ◽  
Vol 18 (10) ◽  
pp. 1175-1180 ◽  
Author(s):  
Luciano Lattuada ◽  
Maria Argese ◽  
Valeria Boi ◽  
Laura Galimberti ◽  
Sonia Gazzetto
Keyword(s):  
Hormone Therapy ◽  
Process Development ◽  
Scale Up

scholarly journals Emerging Freeze-Drying Process Development and Scale-up Issues

2011 ◽  
Vol 12 (1) ◽  
pp. 372-378 ◽  
Author(s):  
Sajal Manubhai Patel ◽  
Michael J. Pikal
Keyword(s):  
Freeze Drying ◽  
Process Development ◽  
Scale Up ◽  
Drying Process

Image Processing for Solar Cell Analysis, Diagnostics and Quality Assurance Inspection

2013 ◽  
pp. 338-375
Author(s):  
Michael G. Mauk
Keyword(s):  
Image Processing ◽  
Image Analysis ◽  
Quality Assurance ◽  
Solar Cell ◽  
Process Development ◽  
Low Cost ◽  
Scale Up ◽  
Image Capturing ◽  
Infrared Cameras ◽  
Primary Focus

Image capturing, processing, and analysis have numerous uses in solar cell research, device and process development and characterization, process control, and quality assurance and inspection. Solar cell image processing is expanding due to the increasing performance (resolution, sensitivity, spectral range) and low-cost of commercial CCD and infrared cameras. Methods and applications are discussed, with primary focus on monocrystalline and polycrystalline silicon solar cells using visible and infrared (thermography) wavelengths. The most prominent applications relate to mapping of minority carrier lifetime, shunts, and defects in solar cell wafers, in various stages of the manufacturing process. Other applications include measurements of surface texture and reflectivity, surface cleanliness, integrity of metallization lines, uniformity of coatings, and crystallographic texture and grain size. Image processing offers the capability to assess large-areas (> 100 cm2) with a non-contact, fast (~ 1 second), and modest cost. The challenge is to quantify and interpret the image data in order to better inform device design, process engineering, and quality control. Many promising solar cell technologies fail in the transition from laboratory to factory due to issues related to scale-up in area and manufacturing throughput. Image analysis provides an effective method to assess areal uniformity, device-to-device reproducibility, and defect densities. More integration of image analysis from research devices to field testing of modules will continue as the photovoltaics industry matures.

Analytical Methods and Bench Scale Preparative Bioseparations

2015 ◽  
Author(s):  
Roger G. Harrison ◽  
Paul W. Todd ◽  
Scott R. Rudge ◽  
Demetri P. Petrides
Keyword(s):  
Isoelectric Focusing ◽  
Analytical Methods ◽  
Process Development ◽  
Scale Up ◽  
Free Flow ◽  
Analytical Methodology ◽  
Bench Scale ◽  
Magnetic Separations ◽  
Analytical Development ◽  
Downstream Processes

The development of efficient and reliable processes for bioseparations is dependent on the availability of suitable analytical methods. This means it is important that work on analytical methodology for the bioproduct of interest starts at the very beginning of process development. Analytical studies are important throughout the development and scale up of the process, as changes can occur either to the product or to its associated impurities from what may be thought of as minor changes in the process. This chapter gives access to the vocabulary and techniques used in quality control and analytical development activities, starting with a description of specifications typically set for a pharmaceutical and the rationale behind them. Then, before discussing the assays themselves, we describe assay attributes, which can be measured and used to help not only the assay developer but also the biochemist and engineer responsible for developing downstream processes determine the usefulness and meaning of the assay. Finally, we turn to assays that are commonly applied in biotechnology, as they apply to biological activity, identity, and purity. These assays are the ultimate yardsticks by which the process is measured. Purification methods are developed for their ability to remove a contaminant from the product of interest, whether it is a related molecule, a contaminant related to a host organism, such as DNA or endotoxin, or a process contaminant, such as a residual solvent or water. Critical to understanding process performance is an understanding of how the assays that measure these contaminants have been developed, what the assay strengths and limitations are, and what they indicate and why. Electrophoresis and magnetic separation are two methods that are now used for the bench scale preparative purification of bioproducts, including living cells. The electrophoresis systems with the highest capacity are free-flow electrophoresis, density gradient electrophoresis, recycling free-flow isoelectric focusing, and rotating isoelectric focusing, and the principles of operation of these are discussed. The physical principles of magnetic separations are presented, as well as magnetic reagents and applications of magnetic separators.

Research Methodology for Microwave-Convective Processing of Grain

2020 ◽  
Vol 9 (2) ◽  
pp. 1-11 ◽  
Author(s):  
Aleksey N. Vasiliev ◽  
V.P. Goryachkina ◽  
Dmitry Budnikov
Keyword(s):  
Research Methodology ◽  
Process Development ◽  
Physical Analysis ◽  
Exchange Processes ◽  
Heat And Moisture ◽  
Adequate Research ◽  
Development Application ◽  
Complicated Task ◽  
Selection Of ◽  
Mathematical Simulation Methods

Studying the effect of microwave fields on the intensification of heat and moisture exchange processes in a granular layer is a rather complicated task, which cannot be effectively solved without an adequate research methodology. In presented materials, a system of principles and approaches for studying processes of microwave-convective grain treatment has been discussed. Based on the explicitly defined process target, functional-physical analysis has been performed that made it possible to specify the most essential factors of process. Morphological analysis of processes shall be performed in several stages. At each stage, targets of process have to be set by excluding combinations of factors that have no reason to be considered at this particular stage of process development. Application of mathematical simulation methods is advisable for selection of optimal options.

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