Biotech 

Microbiosci Releases Cell Bank Characterization Services to Ensure The Biosafety of Biological Products

      

(YorkPedia Editorial):- New York City, New York Jan 30, 2023 (Issuewire.com) – Microbiosci, the division of Creative Biogene, is fully engaged in developing unique technologies that provide global scientists with high-quality products and satisfactory services to facilitate the investigation of microbial research. With high-quality products and services including microbial genome editing, identification, sequencing, proteomics, and metabolomics, Creative Biogene built a mature fermentation platform consisting of large fermentation tanks, bioreactors, and large-scale purification systems to provide high-purity and kilogram-level products. Recently, Creative Biogene announced the release of its cell bank characterization services to ensure the biosafety of biological products.

The purpose of cell bank characterization is to confirm the identity, purity, and suitability of the cell substrate for manufacturing use. Testing procedures vary depending on the biology of the cells, culture history, and available testing procedures. E. coli bacterial cells are the most commonly used production cells, and Microbiosci’s laboratory offers validated methods for the characterization of microbial cell lines. In addition, the research team performs cell bank characterization services according to different needs, including master cell bank, working cell bank and end-of-production cell bank, which will provide reliable, fast, and accurate results to assist customers in evaluating the quality of cell banks.

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Creative Biogene provides customers with comprehensive cell bank characterization services to ensure the biosafety and control of biological and biotech products. Based on leading facilities and excellent platforms, experienced staff provides a wide range of assays to characterize cell banks according to ICH guideline Q5D. Services are provided at research grade or under GLP or GMP regulations.

Cell line characterization of master cell banks (MCB), working cell banks (WCB), and end-of-production cells (EPC) or cells at the in vitro cell age limit (CAL) for production. According to the current regulations, the following aspects must be considered:

Origin and history of cell morphology and growth characteristics of cell lines

Cellular identity

Purity of the cell line (i.e., absence of contaminating cells, microbial contamination, and foreign virus contamination)

Tumorigenicity and Carcinogenicity

Genetic stability

Creative Biogene offers validated methods for the characterization of mammalian and microbial cell lines. References to guidelines for cell line characterization can be found in the Regulatory Repository. With all of these factors in mind, it is important to not only identify the most effective but also provide the most relevant and effective cell line validation program to the client.

“We can respond to customer’s request for any process in the microbial cell bank characterization process.” said Marcia Brady, the marketing director of Creative Biogene, she also added, “we have extensive experience in the characterization of microbial cell bank for pharmaceutical products, pesticides, veterinary medicines, and industrial enzymes.”

About Microbiosci

Microbiosci, as the division of Creative Biogene, is always dedicated to satisfying the needs of clients covering more than 50 countries and districts. As a leading custom service provider in delivering medicine microbiology solutions, Microbiosci has become a well-recognized industry leader with years of experience and professional scientists.

 

(YorkPedia Editorial):- New York City, New York Jan 30, 2023 (Issuewire.com) – Microbiosci, the division of Creative Biogene, is fully engaged in developing unique technologies that provide global scientists with high-quality products and satisfactory services to facilitate the investigation of microbial research. With high-quality products and services including microbial genome editing, identification, sequencing, proteomics, and metabolomics, Creative Biogene built a mature fermentation platform consisting of large fermentation tanks, bioreactors, and large-scale purification systems to provide high-purity and kilogram-level products. Recently, Creative Biogene announced the release of its cell bank characterization services to ensure the biosafety of biological products.

The purpose of cell bank characterization is to confirm the identity, purity, and suitability of the cell substrate for manufacturing use. Testing procedures vary depending on the biology of the cells, culture history, and available testing procedures. E. coli bacterial cells are the most commonly used production cells, and Microbiosci’s laboratory offers validated methods for the characterization of microbial cell lines. In addition, the research team performs cell bank characterization services according to different needs, including master cell bank, working cell bank and end-of-production cell bank, which will provide reliable, fast, and accurate results to assist customers in evaluating the quality of cell banks.

Creative Biogene provides customers with comprehensive cell bank characterization services to ensure the biosafety and control of biological and biotech products. Based on leading facilities and excellent platforms, experienced staff provides a wide range of assays to characterize cell banks according to ICH guideline Q5D. Services are provided at research grade or under GLP or GMP regulations.

Cell line characterization of master cell banks (MCB), working cell banks (WCB), and end-of-production cells (EPC) or cells at the in vitro cell age limit (CAL) for production. According to the current regulations, the following aspects must be considered:

Origin and history of cell morphology and growth characteristics of cell lines

Cellular identity

Purity of the cell line (i.e., absence of contaminating cells, microbial contamination, and foreign virus contamination)

Tumorigenicity and Carcinogenicity

Genetic stability

Creative Biogene offers validated methods for the characterization of mammalian and microbial cell lines. References to guidelines for cell line characterization can be found in the Regulatory Repository. With all of these factors in mind, it is important to not only identify the most effective but also provide the most relevant and effective cell line validation program to the client.

“We can respond to customer’s request for any process in the microbial cell bank characterization process.” said Marcia Brady, the marketing director of Creative Biogene, she also added, “we have extensive experience in the characterization of microbial cell bank for pharmaceutical products, pesticides, veterinary medicines, and industrial enzymes.”

About Microbiosci

Microbiosci, as the division of Creative Biogene, is always dedicated to satisfying the needs of clients covering more than 50 countries and districts. As a leading custom service provider in delivering medicine microbiology solutions, Microbiosci has become a well-recognized industry leader with years of experience and professional scientists.

 

Media Contact
Creative Biogene
[email protected]
6313868241
Shirley, NY 11967, USA
https://microbiosci.creative-biogene.com/

Creative Biogene
[email protected]
Shirley, NY 11967, USA

11967
1-631-386-8241
https://www.creative-biogene.com/

Source :Creative Biogene

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