GMP Plasmid Manufacturing

Plasmids are small circular DNA structures containing DNA fragments,
widely used in genetic engineering and gene delivery. amplification experts

GMP Plasmid Manufacturing

GMP (Good Manufacturing Practice) is an international standard regulating pharmaceutical and life sciences processes, including production, quality control, testing, and storage. It is designed to effectively minimize any potential risks that may arise during pharmaceutical production, which cannot be eliminated even after testing the final product.
Plasmid GMP allied these principles to the production of plasmids, ensuring the provision of safe and effective plasmid products. Our company boasts a team of experts and state-of-the-art GMP facilities, guaranteeing the quality and stability of our plasmid manufacturing process.

We have established cutting-edge plasmid GMP facilities through continuous research and development,
leading the latest trends. Our company demonstrates exceptional performance in various applications, offering solutions in fields including research laboratories, pharmaceutical development, and plant genetic engineering. By delivering reliable and effective results swiftly to our clients, we ensure our services are recognized in the international market.

At our company, we understand the importance of strong partnerships with our customers. We are committed
to offering drug substances with prompt and reliable support, ensuring that our clients can rely on us every step of the way.

The critical components of Plasmid GMP are as follows:

Quality Assurance and Control :
Plasmid GMP must have a system in place to ensure and control quality throughout the production process.
This means securing quality at every stage, from the selection of raw materials to the shipment of the final product.

Documentation and Records :
All steps of the production process must be thoroughly documented. Every material used in plasmid production,
formulation methods, and inspection and test results must be recorded, ensuring traceability.

Facilities and Equipment :
Plasmid GMP requires appropriate facilities and equipment. The production facility must provide a clean and controlled
environment that is compliant with GMP regulations, especially in maintaining regulated temperature, humidity, and pressure.

Education and Training :
All personnel involved in production must be trained in GMP regulations and Plasmid GMP. This is a key element in
maintaining and improving quality during manufacturing.

Inspection and Testing :
Plasmid GMP includes a process for inspecting and testing plasmid quality at particularly critical points.
This encompasses inspections of raw materials, intermediates, and the final product.

Compliance with International Standards :
Plasmid GMP must adhere to internationally accepted standards. This requires active understanding and complying with
international GMP guidelines and related regulations.
Plasmid GMP is crucial in ensuring the safety and efficacy of plasmid production, contributing to the maintenance
and enhancement of quality plasmids used safely in the life sciences sector.


[Dr. Park's Production Facilities]
Fermneter
(BTR) 700L 2ea
- TFF
(BTR) 200LPM
(cytiva) AKTA flux 6LPM
- FPLC
(cytiva)AKTA pilot 600 (0.6LPM)
(BTR) 6LPM
Lead time : 12-14 weeks