Scalable fill & finish for cell and gene therapy CDMO

CdmoGen Co., Ltd is a company that provides GMP manufacturing process technology and overall quality evaluation analysis technology of biopharmaceuticals such as vaccines and gene therapy. They have implemented the Crystal™ M1 Filling Line in their process and use different volumes of the AT-Closed Vial® to better match customers’ needs.

Challenges

As a CDMO, CdmoGen must be flexible, reliable, and able to smoothly scale up manufacturing and transfer technology.

In addition, the world industry is moving quickly. Recently, the development of new drugs in the field of ex vivo gene therapy that complements the strengths and weaknesses of gene therapy and cell therapy has been rapidly increasing. In addition, the development of CAR-T, a customized cancer treatment that has been approved by the US FDA one after another, is rapidly increasing around the world. CdmoGen must therefore be able to rapidly satisfy needs from customers worldwide.

Website

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Project Summary

CdmoGen Co., Ltd is the only company in South Korea offering GMP manufacturing technology and manufacturing facility specialized in virus-based vaccines and gene therapy drugs. We therefore satisfy the needs of companies developing new drugs.

As a specialized CMO company with global reach and specific technology needs from its customers, CdmoGen has implemented filling processes using the Crystal™ M1 Filling Line and several sizes of the AT-Closed Vial® to meet the evolving demand. Aseptic Technologies’ Filling Lines allow for scalability and flexibility of the processes; and enable CdmoGen’s experienced staff to adapt to evolving requirements.

CdmoGen values Aseptic Technologies’ expertise in aseptic filling, and the services that come with our products.

Keerang Park

Gene & Cell Therapeutics CDMO, CEO of CdmoGen Co., Ltd

"Aseptic Technologies vials are well suited for Ex Vivo Gene & Cell Therapy applications: they provide the quality standards for final filling DP products.

The closed filling process provides greater sterility assurance and needs no cleaning and sterilization of the AT-Closed Vial®.

Aseptic Technologies also offers efficient installation, commissioning and validation services and assistance.”

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Figures and facts

Best choice for cell and gene therapy products

High quality standards and available relevant documentation.

Strong service level

Installation, validation, training, maintenance from a reactive team. 

In operation since 2019

Supporting the development and GMP manufacturing of CEFO Co. Ltd.

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