Biotech Analytics

Case example e-LabSHOP from Biotech Analytics UK... 

Biotech Analytics offers a biotech-dedicated portal that provides on-line resources for the biotechnology sector. Founded in 1997, Biotech Analytics is a member of the Bio-Industry Association, UK. Its services... 

Since the commercial introduction of biotech crops, a need has emerged for analytical methods capable of detecting the novel DNA sequences introduced into the plant genome and also methods for detecting the protein products expressed by the... 

The final purity required depends on final use of the product e.g., vaccine with one immunization vs. hormone with chronic use. A detection range of 1 to 100 ppm of residual HCPs has been quoted as a regulatory (and analytical) benchmark for therapeutic proteins.11 Many biotech companies have limited the range to 1 to 10 ppm. The sensitivity and specificity of any unique HCP assay that is used to support such a target should be demonstrated accordingly.11... 

Over the past 40 years, capillary electrophoresis (CE) has advanced significantly as a technique for biomolecular characterization. It has not only passed the transition from a laboratory curiosity to a mature instrumental-based method for micro-scale separation, but also emerged as an indispensable tool in the biotech and pharmaceutical industries. CE has become a method of choice in research and development (R D) for molecular characterization, and in quality control (QC) for the release of the therapeutic biomolecules.In the biopharmaceutical industry, more and more CE methods have been validated to meet International Conference on Harmonization (ICH) requirements. In this chapter, we present real industrial examples to demonstrate the role of CE in R D of pharmaceutical products. The focus in this chapter is on method development analytical control for manufacturing and release of therapeutic proteins and antibodies. 

Because the catabolic and metabolic pathways of biotech drugs are often poorly defined and sufficiently sensitive comparator assays are lacking, additional matrix effect tests by parallelism should be conducted with actual study samples. These are often performed on subject samples with aberrant PK profiles. A pool from several time points with sufficient analyte concentration of that subject is serially diluted. The observed concentration times the dilution factors should be within... 

Robertson, M.P., Ellington, A.D. In vitro selection of an allosteric ribozyme that transduces analytes to amplicons. Nat. Biotech. 1999,17, 62-6. 

DNA polymerase I, Klenow Fragment, EXO(-) was obtained from Funakoshi (Tokyo, Japan). Luciferase, Adenosine-5 -triphosphate sulfurylase, adenosine 5 -phosphosulfate sodium salt, D-Luciferin sodium salt, and magnesium acetate Tetra hydrate were obtained from Sigma (MO, USA). Deoxynucleotide and 2 -deoxyadenosine 5 -0-(l-thiotriphosphate) were obtained from Amersham Pharmacia Biotech (UK). Other chemicals were of an analytical-reagent grade. Instruments ... 

A further level of complexity is often added to the bioanalytics of biotech drugs by the fact that numerous of these compounds are endogenous substances that are already in the body before drug administration. Thus, the analytical technique will detect a so-called baseline level prior... 

Regnier, F. E., He, B., Lin, S., and Busse, J., Chromatography and electrophoresis on chips Critical elements of future integrated, microfluidic analytical systems for hfe science. Trends Biotech., 17, 101, 1999. 

Q-sepharose, chromatofocusing PBE 94, phenyl sephatose HP, G25 sephadex (fine), were obtained from Amersham Pharmacia Biotech (Uppsala, Sweden), and hydroxylap-atite CHT-II, from Biorad (Hercules, USA). All other reagents were of analytical grade. 

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