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The development of antibody purification is challenging since the process aims to obtain abundant yield at a low cost while maintaining the level of product purity and quality. Purification of antibodies by ion exchange chromatography is widely used in monoclonal antibodies manufacturing. Several factors influence the binding characteristics of IgG, such as pH, conductivity or salt concentration, and linear velocity of sample loading into the column. The net surface charge of immunoglobulins, consisting of many different amino acids containing weak acidic and basic groups, will change gradually as the pH of the solution changes. In this study, we performed a simple method of anion-exchange chromatography to selectively remove impurities, using elution buffers with three different pH. Diethylaminoethyl (DEAE) sepharose fast-flow columns were used as weak anion exchanger to obtain high purity levels for IgG antibodies with a broad range of isoelectric points (pI). Increasing pH during anion-exchange chromatography increases the concentration of the dissociated form of weak acidic groups as eluant. SDS-PAGE gel electrophoresis was used to visualize the protein profiles, and monoclonal antibodies activity was determined with indirect ELISA. The result showed that anion-exchange DEAE resins were able to remove protein impurities compared to unpurified mixtures. DEAE column with Tris-Cl buffer pH 8.0 provided optimal conditions compared to pH 8.5 and 9.0. We employed a gradient salt elution procedure and achieved a high peak with 2ml fractions from 250ul of BALB/c mice ascites fluid. However, additional steps for the downstream antibody purification process are needed to meet the industrial standards. [ABSTRACT FROM AUTHOR]

The new Indonesian national regulation for medical device evaluation necessitates the modification of current best practices for solution development. This article describes our current protocol for medical device development and evaluation. We have combined best practices from Simplified Pressman Standard and Indonesian Technology Readiness Level and Clinical Trial Regulation as a base for our medical device development and evaluation methods. Settings. This protocol is currently evaluated by "Konsorsium Riset Alat Ukur Haemoglobin, Kadar Gula (Glukosa dan HbA1c) Non- Invasive" between IPB University, Agency for the Assessment and Application of Technology, and PT Tesena Inovindo. This article is a preposition article developed from literature research and currently evaluated in three years of research in the consortium. We have developed a three-phase protocol, consist of technology, product, and market phase. This article describes in detail for each point for this protocol, using our current non-invasive blood glucose and Haemoglobin level medical device as an example. The technology phase includes primary literature and lab review for technological units for the non-invasive medical device. The product phase describes best practices for laboratory examination for medical device development in the research stage. The market phase describes best practices for medical device development for consumer usage. We are currently evaluating our protocol. and shall report the evaluation within three years. [ABSTRACT FROM AUTHOR]

The non-invasive glucose biomarker device is developing to compensate for the epidemiology of sufferers of metabolic syndrome in the world from increase dramatically. Additionally, to eliminate all risks arising from the invasive measurement. The percentage of population sufferers of glucose metabolic syndrome evenly occurs in each developing and developed country. All individual activities and behaviors are the main causes. The device was conducted at the Electronic and Material Physics Laboratory, IPB University. This study used Assayed Chemistry Clinical Control as a sample, UV-cuvettes as a simulation tool, and a probe from a silk-polylactic acid filament. The incident light source biomarker uses near-infrared (NIR) LED 1200 nm, LED 1300 nm, and FDG03-Ge as a photodetector. Data analysis derived from reflectance values in the form of intensities expanded using Discrete Fourier Transform (DFT). The output analysis of both LEDs was 0.99 pearson, 100% clinical accuracy, and the accuracy of measurement was 8.09 mg/dL on the 1200 nm LED, 10.57 mg/dL on the 1300 nm LED. Then the sensitivity value of both LEDs is 1.00, and the specificity of 1200 nm LED is 0.80, LED 1300 nm is 0.70. Refers to the results of this analysis and the gold standard ISO 15197, LED 1200 nm is an ideal candidate for the incident light source biomarker non-invasive reflectance method. Future research expected to do device testing in-vivo. [ABSTRACT FROM AUTHOR]

Developing blood glucoselevels measurement based on the prevalence of people with impaired glucose metabolism, which is increasing every year. Estimates of the International Diabetes Federation and the American Diabetes Association in 2030 sufferers of glucose metabolism disorders have twofold from 2018. Prevention can be done with monitoring measurement methods that have been available commercially. This research develops a non-invasive biomarker device method that aims at continuous measurement efficiency with minimal risk and reduces production costs. The measurement used standard samples Lyphocheck Assayed Chemistry Control from Bio-Rad Laboratory. The light source modules were tested in the wavelength range of 1050 nm to 1550 nm and FDG03-Ge Photodiode as a photodetector. Then the reflections of the LEDs is a voltage that is converted to analog with Analogue to Digital Converter devices to be processed at the SQ Lite and LibreOffice Calc. Based on the test analysis parameters obtained the two best candidate light source modules are 1050 nm and 1085 nm with a 0.99 pearson correlation, 86% accuracy and zone factor A or 100% value of error grid analysis. Both of these LEDs can be applied as modules in the measurement of blood glucose biomimetic with reflectance method. [ABSTRACT FROM AUTHOR]

Blood haemoglobin level measurement is an essential part of a global attempt at reducing anaemia. This review is to elaborate on current advancements in non-invasive methods to measure blood haemoglobin level. This review also elaborates on current established invasive methods for measuring blood haemoglobin level and its role as a reference standard. This review also maps the wavelength used for non-invasive blood haemoglobin level measurement to our observation on blood haemoglobin level control. The research team has obtained Journal or proceeding articles from Google Scholar and Scopus using the keyword "non-invasive haemoglobin" within its titles from 1980 to 2020. The team has grouped the articles by non-invasive methods, invasive reference methods, and the wavelength used by those methods. There are 128 articles gathered from the keywords. There are 88 articles included in this study. There are 26 light source wavelength combinations that the developers use for non-invasive blood haemoglobin level. Most of the wavelength fits neatly in the window between 500 nm to 1000 nm, where the blood-haemoglobin-level control absorbance is low. The researcher has gathered 13 different non-invasive methods for measuring blood haemoglobin level and those commercially available. Most of the articles we have gathered are unregistered trials, and the majority of methods are unproven. We are taking this as a research limitation. The researchers should conduct a further trial for each method listed. [ABSTRACT FROM AUTHOR]