BPI Lab An essential method in modern analytical laboratories, electrophoresis separates macromolecules (DNA, RNA, and proteins) for analysis based on their size and charge. The popular sodium-dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) technique uses a gel medium. Capillary electrophoresis (CE) can separate ionic species by charge and hydrodynamic radii as well as frictional forces in small electrolyte-filled capillaries. Cheryl Scott looks at the history and applications of these techniques, highlights their appearance in past BPI articles, and points to some…
Wednesday, January 1, 2014 Daily Archives
January 2014 Issue Author Insights
Establishing a Research Agenda in Bioproduction
In an audiocast with managing editor Maribel Rios, Rick Johnston (principal at Bioproduction Group), discusses his views on some changes in the biomanufacturing industry since his January 2008 article, “Establishing a Research Agenda in Bioproduction.†In that article, Johnston reviewed some of the industry’s operational challenges, including the need for supply chain reliability, uncertainty in demand and production processes, and variability in quality assurance and quality control. In the audiocast, he talks about steps the industry has taken toward addressing…
Hydrophobic Interaction Chromatography: Effects of Mixed Electrolytes on Protein Separations
For HIC separations, parameters other than resin surface modifications can be employed to enhance performance. This application note addresses the electrolyte composition of the mobile phase as one parameter responsible for protein adsorption and desorption. The results presented illustrate the benefits regarding capacity and selectivity in HIC of often neglected salts and their mixtures.
From the Editor
Happy 2014! Here is how the new year is shaping up for us so far. Our rotating editorial themes will remain much the same — but our manufacturing theme now shares the spotlight with increased visibility of analytical discussions. Our senior technical editor, Cheryl Scott, has highlighted specific methods in each issue of 2013 and will continue that throughout this year as well. For a list of her 2014 topics, take a look at our editorial calendar…
Innovation in Biopharmaceutical Manufacture
The following is a report from a workshop on innovation in biopharmaceutical manufacturing held at the Annual bioProcessUK Conference in Bristol on 29 November 2012. The aim of the workshop was to access the experience of practitioners in the United Kingdom so as to understand better the challenges and opportunities for innovation in this sector. The workshop addressed the drivers that influence the implementation of process improvements and novel technologies in biopharmaceutical manufacture from the perspective of both manufacturers and…
Optimizing for the Future
The 2013 biennial meeting of the European Society for Animal Cell Technology (ESACT) was in Lille, France this past June. While there, BPI editorial advisor Miriam Monge (vice president of Biopharm Services Ltd.) interviewed ESACT executive committee member Hitto Kaufmann, PhD (vice president of biopharmaceutical process sciences for Boehringer Ingelheim). They talked about some scientific developments being discussed at this year’s ESACT conference as well as Boehringer Ingelheim’s recent announcement about setting up in China and Kaufmann’s own thoughts on…
Analysis By Size and Charge
An early BPI Lab article addressed the power of liquid chromatographic separations for biopharmaceutical laboratory use (1). Such techniques separate biomolecules based on a number of different properties: size, solubility, hydrophobicity/-philicity, binding affinity. The next most powerful means of separation — and thus high-resolution identification — of nucleic acids and proteins/peptides is based primarily on electrostatic properties: electrophoresis. Although it doesn’t really work in a process or preparative setting, it is a fundamental technique in modern biopharmaceutical laboratories, where it…
Assay Acceptance Criteria for Multiwell-Plate–Based Biological Potency Assays
For most biopharmaceuticals, potency is assessed in a bioassay by comparing dose–response curves of the test material and a reference standard. As with all analytical techniques, such assays require criteria by which their execution can be judged objectively to be valid, regardless of whether the desired or expected result is obtained for the test sample. PRODUCT FOCUS: BIOLOGICSPROCESSFOCUS: R&D, QCWHO SHOULD READ: PRODUCT AND PROCESS DEVELOPMENT, ANALYTICAL, QCKEYWORDS: IMMUNOASSAYS, POTENCY ASSAYS, PRODUCT RELEASE, REFERENCE STANDARDS, CONTROL SAMPLES, SAMPLE ACCEPTANCELEVEL: ADVANCED…
Mathematical Model for Production of Recombinant Antibody 14D9 By Nicotiana tabacum Cell Suspension Batch Culture
Transgenic plants are increasingly considered a competing system for producing high-value recombinant proteins for biomedical and industrial purposes at affordable costs (1). Researchers have shown that molecular farming (or biopharming) is a secure technology that is capable of rendering valuable recombinant proteins free of toxins and animal pathogens in a relatively short time (2,3,4,5,6). Scientists have also demonstrated that most recombinant antibodies produced in plants maintain their functional properties (substantial bioequivalence) as well as do those produced in mammalian cell…