Document certifying quality of product
Sequencing and registering nucleic acid data from biologically derived products in international DNA databases provides an objective means to verify the quality of these products, addressing the lack of effective data display in existing methods.
Patent Information
- Application Number
- JP2023175582
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-09-22
- Publication Date
- 2025-04-04
AI Technical Summary
There is no effective way to objectively display original data to prove the quality of biologically derived products such as biopharmaceuticals and food.
By sequencing the nucleic acid contained in the product or raw material and registering it in an international DNA database, original data that objectively certifies the quality of the product can be displayed.
This method facilitates the identification of the quality of the product by providing an objective and verifiable document that lists the registration identifier of the sequence data in a DNA database.
Abstract
Description
[Technical field]
[0001] The present invention relates to information-bearing documents that certify the quality of biological products such as biopharmaceuticals and foods. [Background technology]
[0002] Traditionally, producers of biological products such as biopharmaceuticals and food have prepared documentation of the quality and safety of the products they produce, which they then use as documents to submit to regulatory authorities or to explain to customers. Summary of the Invention [Problem to be solved by the invention]
[0003] There was no way to present original data that objectively attested to the quality of the product. [Means for solving the problem]
[0004] By sequencing the nucleic acids contained in the product or raw materials and registering them in the Sequence read archive, an international DNA database operated by the DNA Data Bank of Japan, the National Center for Biotechnology Information, the European Nucleotide Archive, etc., and then including the registration identifier obtained on the document, it is possible to display the original data that objectively proves the quality of the product.
[0005] A preferred embodiment of the present invention comprises: Nucleic acids are extracted from the cells used in biopharmaceutical manufacturing, and sequence data is obtained through a workflow using a general next-generation sequencer. The aforementioned sequence data is registered in international DNA databases such as DDBJ, NCBI, and ENA, and the resulting registration identifier is then included in a document certifying the quality of the product. Effect of the Invention
[0006] The document certifying the quality of the product of the present invention makes it easier to identify the quality of the product. EXAMPLES
[0007] Nucleic acids from the cultured CHO cells were extracted and sequence data was obtained using a next-generation sequencer. The data was registered in the DDBJ SRA database and the identifier DRS171016 was obtained. DRS171016 was included in the documentation certifying the quality of products derived from the cultured CHO cells. Ginrin Showa can be found in the international DNA database NCBI at the following URL (https: / / www.ncbi.nlm.nih.gov / biosample / SAMD00159386). [Industrial Applicability]
[0008] The present invention can be used in the industrial field of producing biological products.
Claims
[Claim 1] A document that certifies the quality of biological products that are not living animals, such as biopharmaceuticals and foods, A document certifying the quality of a product that lists a specific biological product, intermediate product, or waste product, and an identifier on the Sequence Read Archive, an international database of nucleic acid sequence data derived from the aforementioned specimen, operated by the DNA Data Bank of Japan, National Center for Biotechnology Information, European Nucleotide Archive.