Home » Biologics CDMO » IVD reagent raw material supply

ProIVD Service Workflow

We can provide customized production service based on the actual needs of clients.

The whole process begins with plasmid optimization and tranfection, to stable cell pool / cell line development, and finally to material manufacturing. Clients can either choose stable cell pool development solution which is faster and cheaper or cell line development which is more stable and further increases titer.

BPG quality system enables IVD raw material production

In order to meet higher regulatory requirements, GenScript ProBio can provide BPG (Bioprocessing) quality system for IVD raw material production.

Compared with conventional reagent service, BPG system can ensure clear traceability via establishment of a sound documentation system; and can guarantee stable and controllable product quality through QA supervision which can strengthen process control and reduce process risks.

In cell pool / cell line development stage, clients can have a tight control over the key processes and results by obtaining process reports of each development stage.

Reagent service BPG manufacturing Benefits to clients
Animal source free Yes Yes
Raw material documentation No COA Provide COA of raw materials for clients to trace back to raw material specifications
Production Report ROA Production report Report contains both key processes and analysis results for clients to review and audit key procedures
Support the audit No Optional Ensure system quality is consistent and meets clients’ needs
Process monitor No Optional
(QA conduct random inspections)
Ensure better process control, reduce risks and guarantee product meets specifications
Record / batch record No Record
(optional: batch record + QA approval)
The original records provide audit evidence and can trace the original data
Quality systems
(deviations, OOS, etc)
No Well documented Keep the process and quality system optimized constantly and ensure product quality meets customers’ needs
Reagent service ProIVD service Benefits to clients
Plasmid construction COA
pUC57
COA
pUC57
plasmid construction report
Guarantee delivery in 4 weeks and as fast as in 3 weeks
Transfection Transfection evaluation report
PCB preparation PCB
ROA
PCB
Cell pool / line development report
Reports (plasmid / transfection / development) are prepared for users to control the implementation and quality of key processes and ensure traceability

Strong 200L/500L capacity to ensure large-scale production

  • We can provide different cultivation equipment for each production scale considering both flexibility and cost-effectiveness.

    At present, we have 2,600L production capacity to ensure immediate scheduling without waiting, and guarantee large-scale material supply from gram level to kilogram level.

  • Production scale Instrument
    1L Flask
    5L Flask
    10L WAVE
    20L WAVE
    50L 2*WAVE
    50-500L Bioreactor
    8*200L + 2*500L