Cell and gene therapy CRDMO Service

Jiangxi Chiyan has established a relevant cell bank, which can provide customers with a full range of cell and gene therapy CRDMO services such as cell, cell therapy, viral AAV.

Establishment of cell bank

Integrated cell bank manufacturing, characterization, and publishing services are designed to demonstrate safety and ensure the durability of cells throughout your biopharmaceutical lifecycle. Cell Bank Manufacturing Overview:

The ability of GMP to control, work, or produce a cell bank

Comprehensive characterization and release from incoming seed bank QA to COA

Experience with more than 50 cell lines; 

Human and non-human Sequencing to characterize the insertions 

Built-in surplus in expansion plan 

Standard batch records due to efficient regulatory reviews 

Supports multi-batch and dedicated PM

Available storage solutions

Our cell bank manufacturing and publishing platform approach 

Consulting, Batch record development, process transfer/Starting material release testing, cell expansion/acquisition, in-process testing and characterization, Release testing /COA, cell bank creation.

Cell therapy 

We offer a complete portfolio of development, manufacturing, and testing services for autologous, allogeneic, and gene-mediated cell therapies that move quickly into clinical trials and support commercialization programs around the world.

Services include:

Dedicated GMP manufacturing kit model 

Analysis and development ---- potency and rapid sterility

Process development ----- expansion or production expansion 

Virus vector production platform to ensure supply

Regulatory support

More cell therapy services: 

Technical consultation, collection/preparation/identity chain, content development/analysis preparation, amplification-GMP production, collection/preparation/filling, release/stability testing, delivery to patient, patient follow-up supervision.

Virus product 

Comprehensive CRDMO and testing services for viral products for biopharmaceutical manufacturing are designed to accelerate clinical time and support commercial projects around the world. By drawing on more than two decades of virology expertise, we offer the following services:

• Accelerate technology transfer

• FDA registered facility 

• Integrated manufacturing and testing, including gene sequencing, foreign factor screening and stability studies 

• Process and analysis development

• Scalable capacity 

• Global regulatory support Virus experience includes:

• Lentivirus 

• Retroviruses 

• Adeno-associated virus (AAV) 

• Adenovirus

Master virus library and working virus library 

Pure viral seeds are not just starting materials for creating viral banks, they are the basis for assessing biopharmaceutical life cycle quality. We offer full-service solutions from master virus bank creation to drug lot release, including complete characterization of genetic and phenotypic stability.

Oncolytic virus 

As an emerging "double threat" in the fight against cancer, oncolytic viruses are used as monotherapies or in combination with existing checkpoint inhibitor /T cell therapies to provide an enhanced therapeutic response. Since 2018, we have invested significant resources to create the necessary manufacturing and testing infrastructure to facilitate rapid development. 

Virus vector manufacturing and testing 

Our integrated viral vector manufacturing and testing platform provides customers with faster, more predictable GMP materials to accelerate progress into human clinical trials.

Overview of viral vector production platform 

• Ideal for Lenti, AAV and adenovirus viral vectors

• Better supply chain control - materials are stocked, assembled and released 

• Accelerate program startup - plug and play if you meet defined criteria 

• Elements include raw materials, cell lines, MCB/WCB, plasmids, upstream/downstream processes, analysis, batch records, Sops, trained staff 

• Reduce the risk of contamination with Corning HyperStacks' closed adhesion production system

 • Dedicated suite model: Upstream and downstream are executed in the same suite 

• Up to 250 L yield (depending on the gene carrier of interest) 

• On-site integration process and release testing