Tag: <span>pharmaceuticals</span>

Quantitative Endotoxin Assay of Ultrapure Water

The cell wall components of gram-negative bacteria, such as E. coli and Pseudomonads, are designated as endotoxins. They have a hydrophilic polysaccharide and a lipophilic lipid component and, unlike the bacteria from which they originate, are highly heat and pH-stable. Endotoxins are pyrogens (i.e., they can cause fever if they come in contact with mucous membranes or enter the bloodstream). According to the prevalent
pharmacopeias, the defined limit values for endotoxin content may not be exceeded during the manufacturing process of pharmaceuticals. In mammalian cell cultures that are used to produce biopharmaceuticals, such as immunoglobulins, the presence of endotoxins can lead to cell death. For this reason, ultrapure media (i.e., ultrapure water, with levels proven to be below the limits) must be used to manufacture biopharmaceuticals or to propagate cell lines or cell cultures. The objective of this study is to demonstrate that the ultrapure water produced by the arium pro VF system exhibits an endotoxin content that is far below the prescribed limits and that can be used for the applications mentioned above.

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Biologics Production

biopharmaceuticals bioproduction endotoxin assay endotoxins gram-negative bacterial h20 pharmaceuticals pyrogen ultrapure water

Transient Expression of Recombinant Immunoglobulin in HEK-293 and CHO-S Cells Using BacMam Transduction

BacMam transduction technology combines the ability of baculoviruses to maintain and amplify large gene inserts with the desirable post-translational characteristics of proteins expressed in mammalian cell lines. Improved versions of BacMam expression vectors demonstrate increased transduction efficiencies and wider ranges of permissible, mammalian host cells. BacMam technology has been used successfully in the fields of cell-based assays for drug discovery and for imaging of subcellular structures and functions. The development of a large-scale platform for the transient expression of recombinant proteins using BacMam transduction would significantly improve the current transient transfection methodology. We report our initial results obtained using BacMam constructs expressing a humanized rIgG. Serum-free suspension cultures of HEK-293 and CHO-S cells were cotransduced with BacMam viruses at total multiplicity of infection ratios between 10 and 20. Purified yields of 18.9 mg/L were obtained for shake-flask cultures of HEK-293 cells under nonoptimized conditions. These results illustrate the potential of the BacMam system to produce significant quantities of recombinant proteins in mammalian host cells…

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Biologics Production

bacmam bacmam transduction baculovirus expression cho-s cells hek-293 mammalian cell lines mammalian host cells pharmaceuticals post-translational chacteristics recombinant proteins

Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries

An interesting situation occurred ten years ago in an industry where quality had been the critical factor in management decision-making. Quality was abruptly bumped to second place behind pricing, which started a global rush to find lower-cost suppliers and eventually resulted in massive outsourcing. During this evolution, the importance of quality systems for the pharmaceutical and biopharmaceutical community was recognized by regulatory agencies that began establishing risk management standards.

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Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

biologics biopharmaceuticals cgmp fmea GMP iso pharmaceuticals QRM quality risk management risk analysis risk evaluation risk management