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To mitigate xenobiotic risk, HumanKine® products are made without any raw material from foreign organisms. One of the most dangerous molecules is endotoxin, a bacterial lipopolysaccharide that can cause sepsis. Material originating from a foreign organism in a therapeutic creates the risk of medical complications. Many non-GMP proteins will be affinity purified and have residual tags so are not suitable to use in GMP manufacturing even with additional testing and risk assessments. To avoid these issues, HumanKine® proteins are produced without tags and purified using biophysical methods. This may cause issues if the protein is part of a therapeutic. Additionally, the presence of a tag may increase the immunogenicity of some proteins. This, in turn, may interfere with the active site of the protein resulting in altered biological activity. Unfortunately, these tags often change the structure of a protein of interest. Purification tags are often used to isolate proteins. Additionally, if a customer files a complaint, the issue can be pinpointed by examining the documentation. Thus, the manufacturer can provide documentation of the entire process to customers so that they can verify that the work was done to their exact specifications. Each step in the manufacturing process requires documentation of who performed the work and what was done. EC50 is less than 5 ng/mL as determined by a 4 parameter non-linear regression model.Īn advantage of the extensive documentation in the QMS is traceability. NIH/3T3 cells were plated and serum starved with 0.1% FBS for 24 hours and increasing concentrations of recombinant human PDGFbb were added for 48 hours before the addition of PrestoBlue Cell Viability Reagent.
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Viable cell number was quantitatively assessed by PrestoBlue Cell Viability Reagent. This protein stimulates dose-dependent proliferation of the NIH/3T3 mouse fibroblast cell line. Lot to lot comparison of GMP-grade Animal-free Recombinant human PDGFbb (Catalog: HZ-1308). These documentation and training practices limit the sources of variability, resulting in high lot reproducibility. Besides detailed procedures, QMS outlines rigorous training to ensure laboratory personnel consistently follow the same production protocols.
#ISO 13485 GMP HOW TO#
5 Highlights of GMP-Grade HumanKine ProductsĪ key part of the QMS is documentation on how to perform each step, from buying raw materials to packaging the final product.
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Combined with the advantages of the human cell-expressed system, HumanKine® GMP-grade proteins are ideal for use in cell and gene therapy manufacturing.
#ISO 13485 GMP ISO#
The ISO 13485 certification therefore ensures quality, consistency, and traceability. It outlines everything from manufacturing guidelines to handling customer complaints. More formally, it is an internal system to document standardized company practices for processes, procedures, and responsibilities to ensure product safety and quality.
#ISO 13485 GMP MANUAL#
Informally, this can be thought of as a company-wide instruction manual for reproducibility and continual improvement. The heart of this certification is the quality management system (QMS). Therefore, a GMP certified protein is one that can used in cell and gene therapies. 'GMP' stands for Good Manufacturing Practice, which refers to the quality control procedures set out by agencies that control the authorization of pharmaceutical and medical products. ‘13485’ refers to the specific certification for medical devices and ancillary products, such as cytokines. Formed in 1943, ISO is a non-governmental body charged with promoting worldwide standards to ensure safe, reliable, and high-quality products. What does that certification mean? ‘ISO’ stands for International Organization for Standardization. This year, Proteintech received ISO 13485 certification and now offers GMP-grade products. GMP Manufacturing, benefits, and ISO certifications explained