scholarly journals The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation

2022 ◽  
Author(s):  
Xuanwen Li ◽  
Fengqiang Wang ◽  
Hong Li ◽  
Douglas D Richardson ◽  
David J Roush

Abstract Non-ionic surfactant polysorbates (PS), including PS-80 and PS-20, are commonly used in the formulation of biotherapeutic products for both preventing surface adsorption and acting as stabilizer against protein aggregation. Trace levels of residual host cell proteins (HCPs) with lipase or esterase enzymatic activity have been shown to degrade polysorbates in biologics formulation. The measurement and control of these low-abundance, high-risk HCPs for polysorbate degradation is an industry-wide challenge to achieve desired shelf-life of biopharmaceuticals in liquid formulation, especially for high-concentration formulation product development. Here, we reviewed the challenges, recent advances and future opportunities of analytical method development, risk assessment and control strategies for polysorbate degradation during formulation development with a focus on enzymatic degradation. Continued efforts to advance our understanding of polysorbate degradation in biologics formulation will help develop high-quality medicines for patients.

2014 ◽  
Vol 30 ◽  
pp. 153-160 ◽  
Author(s):  
Catherine EM Hogwood ◽  
Daniel G Bracewell ◽  
C Mark Smales

2003 ◽  
Vol 47 (2) ◽  
pp. 103-112 ◽  
Author(s):  
L. Rieger ◽  
J. Alex ◽  
S. Winkler ◽  
M. Boehler ◽  
M. Thomann ◽  
...  

To ensure correctly operating control systems, the measurement and control equipment in WWTPs must be mutually consistent. The dynamic simulation of activated sludge systems could offer a suitable tool for designing and optimising control strategies. Ideal or simplified sensor models represent a limiting factor for comparability with field applications. More realistic sensor models are therefore required. Two groups of sensor models are proposed on the basis of field and laboratory tests: one for specific sensors and another for a classification of sensor types to be used with the COST simulation benchmark environment. This should lead to a more realistic test environment and allow control engineers to define the requirements of the measuring equipment as a function of the selected control strategy.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Farida Chamchod ◽  
Prasit Palittapongarnpim

Abstract Background The presence of nosocomial pathogens in many intensive care units poses a threat to patients and public health worldwide. Methicillin-resistant Staphylococcus aureus (MRSA) is an important pathogen endemic in many hospital settings. Patients who are colonized with MRSA may develop an infection that can complicate their prior illness. Methods A mathematical model to describe transmission dynamics of MRSA among high-risk and low-risk patients in an intensive care unit (ICU) via hands of health care workers is developed. We aim to explore the effects of the proportion of high-risk patients, the admission proportions of colonized and infected patients, the probability of developing an MRSA infection, and control strategies on MRSA prevalence among patients. Results The increasing proportion of colonized and infected patients at admission, along with the higher proportion of high-risk patients in an ICU, may significantly increase MRSA prevalence. In addition, the prevalence becomes higher if patients in the high-risk group are more likely to develop an MRSA infection. Our results also suggest that additional infection prevention and control measures targeting high-risk patients may considerably help reduce MRSA prevalence as compared to those targeting low-risk patients. Conclusions The proportion of high-risk patients and the proportion of colonized and infected patients in the high-risk group at admission may play an important role on MRSA prevalence. Control strategies targeting high-risk patients may help reduce MRSA prevalence.


2018 ◽  
Vol 16 (1) ◽  
pp. 103-106
Author(s):  
M. K. S. A. Millat ◽  
N. M. Shafy ◽  
S. T. Sharmy ◽  
F. Yeasmin ◽  
M. F. Karim ◽  
...  

Despite the endemicity of brucellosis, there is no report on the equine brucellosis in Bangladesh. The Rose Bengal Test (RBT) was used to determine the seroprevalence of Brucella antibodies amongst 112 horses from different areas of Bangladesh. The overall seroprevalence of equine brucellosis was 1.79%.The prevalence recorded in Ghatail area was 3.45% and there was no positive reactor in Shakipur and Savar areas. Sex wise prevalence showed that the prevalence was 3.08%in female and 0.00% in male horse. Only the adult (>3 years of old) horses showed the positive RBT reaction (2.35%), whereas young (<3 years of old) horses did not showed positive RBT reaction. The present study reports the first serological prevalence of Brucella infection in horses in Bangladesh. There is need for the inclusion of horses in brucellosis surveillance and control strategies in Bangladesh to safeguard people from high risk.


ACTA IMEKO ◽  
2014 ◽  
Vol 3 (1) ◽  
pp. 4
Author(s):  
S. S. Carlisle

<p>This is a reissue of a paper which appeared in ACTA IMEKO 1967, Proceedings of the 4th International Measurement Congress, 1967, Warsaw, vol. 1, pp. 37-50.</p> <p>The paper sets a frame on the role of measurement and control as critical tools to support the automation of manufacturing processes. In this perspective three main requirements for measurement are discussed, i.e., to identify where automation can be most profitably used; to investigate individual process behaviors and hence to formulate process control strategies; and finally to perform quality control of products.</p>


2011 ◽  
Vol 317-319 ◽  
pp. 757-763 ◽  
Author(s):  
Xi Wen Zhang ◽  
Xiao Dong Wang ◽  
Yi Luo ◽  
Lin Teng ◽  
Liang Chen ◽  
...  

Assembly is one of the most important procedure in manufacturing complex miniature products. Batch assembly is limited by the manual manipulation, for which specially trained technicians is required. In order to automatically assembly certain complex miniature products consisting of multiple parts with different shape and various dimension, and also to reduce the production cost and improve efficiency, an assembly system was developed. Hardware architecture of the system was discussed in detail. Measurement and control strategies in assembling procedure were presented. Local feature extraction and fitting algorithms, reference datum setting were applied to overcome the occlusion. Linear and circular feature fitting from multiple local images of parts, coordinate transformation and the compensation of stages assembly error angle among three local coordinates were adopted to improve the measuring accuracy of vision system. Microscale force sensor was introduced to control the contact force, and the accuracy obtained is less than 1mN. Torque sensor was adopted for sensing the torque during the screw thread assembling, stepping motor and flexible coupler were applied to make the torque smoothly transferred, all of which help precisely measuring and controlling the torque during the M1.4 screw thread assembly.


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