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Bioprocess Validation

Bioprocess validation involves a series of activities taking place over the entire production cycle of a bio-product. At Creative Biostructure, we can help you review your experimental designs, materials and facilities through laboratory-, pilot-, and/or commercial process. We can also help evaluate the product’s quality, such as sterility, impurity, consistency, repeatability, and so on. Finally, we can help you establish a reasonable validation system to meet both FDA and EU regulations.

An important part of bioprocess validation requires the evaluation of active pharmaceutical ingredients (APIs) and possible contaminants (i.e., mycoplasma, bacteria, endotoxin, and so on) during the development and manufacture processes of human and animal drugs, or other biological products. Specifically, data are collected, evaluated and documented from every stage of a specific project at all desired levels. In this way, bioprocess validation establishes the scientific evidence that a process is capable of consistently delivering quality product. So, effective process validation contributes significantly to assuring drug quality, safety, and efficacy.

Creative Biostructure provides services for the detection and evaluation of impurities following production by fermentation or cell culture. We also help our customers to determine the optimal strategies for removal of those impurities. Our in-house EM platform not only provides the detailed information about the inherent characters of given samples, but also enables the identification and characterization of contaminants.

Bioprocess validationFig. 1 Electron microscopic photographs of mycoplasmas.

At Creative Biostructure, we are devoted to help our customers establish feasible, consistent and reproductive bioprocesses for the production of safe, high quality biopharmaceutical products.

Please feel free to contact us for a detailed quote.

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Reference

  1. Hans G. Drexler, Cord C. Uphoff, Mycoplasma contamination of cell cultures: Incidence, sources, effects, detection, elimination, prevention. Cytotechnology. 2002; 39:75-90.

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