GMP mRNA & LNP

장점

품질

• Product Quality and Speed

  Performance
  

  Speed
  

   

  Quality
  

• Comprehensive Analytical Panel

  Our comprehensive analytical panel allows for customized in-process control, release testing, and stability studies for plasmid, mRNA, and LNP. This enables us to tailor our approach to meet the specific needs of your project and ensure that the final product is of the highest quality.

  

  With our advanced analytical tools, we monitor every step of the production process to identify any potential issues early. This allows us to take corrective action quickly and efficiently when necessary. Our commitment to using the latest analytical techniques means that you can have confidence in the accuracy and reliability of our testing methods.

  

• Project Timeline

  

  Platform Technology Timeline: At PackGene, we pride ourselves on our industrial-leading timeline of 6.5 months from PCB to GMP release. This streamlined process makes us highly competitive in the market, allowing us to provide you with the highest quality GMP mRNA and LNP production in a timely and efficient manner. Trust us to deliver exceptional results, while still meeting all regulatory requirements and maintaining the highest quality standards. With our efficient timeline and commitment to excellence, we are confident that we can meet and exceed your expectations for your next project.

• Quality Management System

  Our Quality Management System is designed to ensure that every aspect of the product quality realization process is carefully monitored and controlled. This includes personnel, facilities and equipment, environment, materials, manufacturing, QC, and product release. We also employ validation and qualification protocols to ensure that our products meet the highest standards of quality. In addition, our quality assurance program includes change control, deviation handling, complaint handling, quality management review, recall procedures, internal audits, and corrective and preventive action planning, all guided by our quality risk management framework. Finally, all of our processes are thoroughly documented to ensure transparency and traceability, providing you with the confidence that your product is of the highest quality.

  

  Our commitment to quality is at the heart of everything we do. Our Quality Management System is a comprehensive framework that ensures every step of our process is carefully planned, executed, and monitored to meet the highest standards.

• Documentation

  Comprehensive documentation is essential to ensure regulatory compliance and product quality. At our facility, we provide extensive documentation covering all aspects of the drug development process, including project management, operation procedures, and quality control. This documentation is meticulously maintained throughout the entire lifecycle of the drug, from R&D, to clinical trials, and commercialization.

  Project Document

  • Enquiry Assessment
  • Manufacture Summary
  • Packaging Summary
  • Delivery Summary
  • Agreement and Contract

   

  Operation Document

  • SOPs
  • Goods Receiving Record
  • Work Order
  • Batch Record
  • Shipping Request
  • Distribution Record
  • Logbook
  • Environment Monitor

   

  Quality Document

  • Specification
  • Material and Product Test
  • CoA
  • Batch Record Review and Release
  • Stability Data
  • Validation Report
  • Supplier Qualification

Resources

• GMP mRNA Service Flyer