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Compliance gene synthesis services

Compliance gene synthesis service

We have established an efficient and strict gene synthesis quality system in accordance with the biological drug application rules, providing complete and standardized experimental record organization and writing that meets the requirements of biological drugs, gene therapy, cell therapy and other product telegrams, including reagent and consumable information, instrument and equipment information, complete experimental process and results, etc., to ensure the compliance, authenticity, reliability and traceability of the production process. We provide gene synthesis compliance reports applicable to IND/NDA application standards for research and development enterprises of biological drugs, gene therapy and fine running therapy, meeting the requirements of project application.
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Service Advantages

High quality assurance

High quality assurance

01/04
The sequence is accurate and error free

The sequence is accurate and error free

02/04
Full traceability and tracing throughout the process

Full traceability and tracing throughout the process

03/04
Provide IND declaration standard compliance report

Provide IND declaration standard compliance report

04/04

Service Period

  Conventional gene synthesis Compliance gene synthesis
Production process Batch production process, entering the regular order production process Independent production process: Production is carried out by production personnel who have received professional compliance training
Traceability Cannot be fully traced separately without special records Full traceability: Information such as instruments, reagents and consumables, operation time, and operators can all be traced
Instrument certification Measurement verification 3Q Confirmation (Key Testing Equipment)
Security and confidentiality Online Batch Management Offline managed by a specialized team
Experimental report Printable electronic form for transaction records Real, complete, reliable, and traceable experimental records
Cooperate with the audit Not provided Can provide (internal on-site audit/external dedicated personnel for review)
Save time Free storage of paper materials for 10 years Permanent preservation of paper and electronic materials

 

Service&Support

Inquiry and ordering

Inquiry and ordering

Directly log in to GentleGen GBS Online Ordering System,Automatically obtain quotes and place orders; stay“Data Download”Download the corresponding service subscription form and send an email. We will provide you with a quotation as soon as possible.

Data Download

Data Download

Product manual download、order form

ordering information

ordering information

Email: marketing@gentlegen.com Phone: 0512-67998818, ext. 8888

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