CRO Service

CRO Service

Bioheng had established cGMP grade production platform for manufacturing plasmid, virus and cells, and an advanced quality assurance system to guarantee the regulatory requirements are strictly met. With our powerful translational center and specialized R&D team, we are leading in many aspects of cell therapy and own several innovative proprietaries. Currently, several universal CART projects have moved forward to the clinical trial stage. Based on our sophisticated immunotherapy and gene editing expertise, we could offer our clients a wide range of professional service including but not limited to discovery, pre-clinical,target, GMP production consulting and IND services, as well as packaged “all in one” solution. 

Service List

Novel target screening and verification

We have established a multidisciplinary platform for high throughput targets screening and target verification to facilitate novel immunotherapy development.

Pre-clinical study for cell therapy

Provide complete solution for various pre-clinical studies for cell therapy products development, and customize the service to cater project objectives.

GMP grade production of plasmids, viruses and cells 

We provide GMP grade production of plasmids, viruses and cells in compliance with cFDA regulatory. Our stringent QA system and end products QC assure meet IND and clinical trial requirements.

Contract research service and data analysis

We have established molecular, cell and animal platform, allowing us to offer high quality research service, such as gene sequencing, gene editing, viruses packaging, tumor model.

GCRISPR-CAS9 gene editing and model establishment

With the powerful gene editing platform, we could manipulate interested genes easily, which provide the powerful tools for gene function study and disease model establishment.

 IND submission and consulting for cell/gene therapy products

With our strong expertise in cell therapy and gene therapy, we provide IND submission and consulting service, ranging from clinical trial design, IND filing, CDE conference to whole project management.

Quality management system establishment for cell therapy and onsite audit

Help clients build quality management system, and supervise the implementation following cFDA instructions; provide professional advice for amend.

All in one package (from plasmid design to CMC

Provide all in one package solution for immunotherapy or gene therapy clients, including discovery study, pre-clinical, IND filing, and small scale production etc.

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