Analytical Test Methods for Biological and Biotechnological Products

Author(s):  
Nadine Ritter ◽  
John Mcentire
2002 ◽  
Vol 85 (4) ◽  
pp. 925-932 ◽  
Author(s):  
Mark Vandeven ◽  
Thomas Whitaker ◽  
Andy Slate

Abstract Processed food manufacturers often use acceptance sampling plans to screen out lots with unacceptable levels of contamination from incoming raw material streams. Sampling plan designs are determined by specifying sample sizes, sample preparation methods, analytical test methods, and accept/reject criteria. Sampling plan performance can be indicated by plotting acceptance probability versus contamination level as an operating characteristic (OC) curve. In practice, actual plan performance depends on the level of contamination in the incoming lot stream. This level can vary considerably over time, among different crop varieties, and among locales. To better gauge plan performance, a method of coupling an OC curve and crop distributions is proposed. The method provides a precise probabilistic statement about risk and can be easily performed with commercial spreadsheet software.


2018 ◽  
Vol 18 (3) ◽  
pp. 168-174
Author(s):  
O. V. Golovinskaya ◽  
S. L. Lysikova ◽  
Yu. N. Lebedeva ◽  
N. A. Alpatova ◽  
A. A. Movsesyants ◽  
...  

Biotechnological products, like all other medicinal products, have to comply with efficacy, safety and quality requirements. Quality evaluation of medicines includes assessment of test methods used to control medicinal product quality (described in product specification files provided by the manufacturer), laboratory testing of samples using these methods, as well as assessment of the registration dossier materials, including materials on test method validation included into the product specification files. One of the most important quality parameters of biotechnological products is biological activity, i.e. specific ability of a product to induce a desired biological effect. The article presents the results of a detailed analysis of methods used for determination of biological (specific) activity that are described in product specification files of various biotechnological products. The aim of the study was to demonstrate the importance of proper presentation of methods used for assessment of biological (specific) activity of biotechnological products and familiarise specialists engaged in elaboration of product specification files with the principles of presenting data in the «Biological (specific) safety» section. The analysis of documentation helped summarise the most common mistakes and omissions, formulate general recommendations concerning the description of methods, develop a general structure of the «Biological (specific) safety» section with detailed guidance on what to include in each of the subsections. Rationalisation of information presented in this part of the product specification files will help reduce the number of expert body’s requests for additional information/documents and will help ensure that laboratory testing is performed at a high professional level and within a prescribed period of time.


2013 ◽  
Vol 440 ◽  
pp. 74-81 ◽  
Author(s):  
J.W. Bridge ◽  
C.A. Mahaffey ◽  
M.L. Peterson

Thoroughbred horse racetracks consisting of granular composite materials, also referred to as synthetic tracks, were developed for the racing industry with the goal of increasing safety to horses and jockeys and reducing maintenance efforts. These granular composites consist of sand, polymer fiber, and rubber bound together with a high-oil wax binder. The mechanical properties of these surfaces are significantly influenced by material composition, environmental factors, and surface maintenance procedures, and are susceptible to both environmental and mechanical-induced degradation over time. Using a combination of material analytical tests, surface mechanical and chemical properties and changes to them are assessed. Tests used to characterize the surface materials composition include Soxhlet wax extraction, wax oil extraction and sand morphology. Additionally, water-holding capacity, wax differential scanning calorimetry (DSC), gas chromatography (GC), Fourier transform infrared spectroscopy (FTIR), and x-ray fluorescence (XRF) provide insight to the thermal mechanical response of these surfaces as temperature and track composition/conditions change. Pertinent test results for two U.S. synthetic racetracks are included in this work to demonstrate the practicality of using this suite of testing. These tests and results provide a basis for racetrack maintenance decisions with the goal of achieving a more consistent racing surface that should ultimately reduce equine, and by extension jockey, injuries.


Author(s):  
Samara Bin Salem ◽  
Premanandh Jagadeesan ◽  
Premanandh Jagadeesan ◽  
Premanandh Jagadeesan ◽  
Premanandh Jagadeesan ◽  
...  

Gold standard is a very common but most powerful terminology amongst diagnostic and analytical laboratory scientists. The genesis dates back to 19th century monetary system where the standard economic unit of account is based on a fixed quantity of gold and has nothing to do with science. Nevertheless, this term had taken an indispensable place in the testing arena ever since its appearance in reputed scientific journals. Application of this term in analytical science from both proponents and opponents perspective has been discussed in detail. Its applicability with regards to bacteriological culture and pulsed field gel electrophoresis for typing bacteria and clinical diagnosis as examples are presented. In conclusion, diagnostic and analytical test methods should not be described or presented in a misleading manner as it is likely to create an erroneous impression on the use of such terminology. We need to revisit gold standard terminology for its appropriation.


2013 ◽  
Vol 96 (2) ◽  
pp. 466-470 ◽  
Author(s):  
Steffen Uhlig ◽  
Stefanie Eichler ◽  
Petra Gowik

Abstract Precision data, such as laboratory-to-laboratory SD (sL) and repeatability SD, obtained from interlaboratory tests are needed to assess analytical test methods. These precision data describing random error are subject to random variation. In order to avoid distorted assessments of test methods, interlaboratory tests must fulfill minimal requirements for achieving, e. g., a desired reliability in sL. In 2009, McClure and Lee considered reliability of sL as a characteristic of an interlaboratory study. They developed an approach to approximate that reliability to make it possible to adapt the study design of an interlaboratory study to a desired reliability in sL. The McClure and Lee approach introduces the "margin of relative error" to arrive at the magnitude of the uncertainty in sL. This article discusses their approach and presents a generalized approach. The limitations of McClure and Lee's approximation are shown to result in underestimation of the actual variability of sL due to the disregard of the inherent negative bias of sL. This bias corresponds to the fact that the expected value of the obtained sL lies below the true value σL one would obtain in an interlaboratory study with an infinite number of laboratories and replicates. In order to achieve the reported level of reliability in sL, the actual number of laboratories required is typically approximately 25% higher than that calculated by McClure and Lee. We present a generalized approach using "margins of relative random error," which takes the impact of the bias of the sL into account, resulting in a more realistic estimation of the variability of the precision parameter sL .


1962 ◽  
Vol 71 (7) ◽  
pp. 495-501 ◽  
Author(s):  
George W. Larson ◽  
David C. Hubbell ◽  
Lloyd E. West
Keyword(s):  

Sign in / Sign up

Export Citation Format

Share Document