Contact US

+86 18721174739

Email

jiyebio@jeyoupharma.com

Production services

Test Service Items

Development Services

Registration

Sales Outsourcing Services

Cell Bank

Service Scope

Jiye Bio offers cell bank related services including: MCB/WCB generation, MCB/WCB storage

Facility and equipment

DS Manufacturing

Service Scope

Jiye Bio offers comprehensive services including:

 

  • Technology transfer for protein/antibody-based products from clinical early phase to commercial phase.
  • Toxicology batch production
  • IND-enabling CMC support
  • Process performance qualification (PPQ)
  • GMP production for investigational products
  • Commercial production

Facility and equipment

Jiye Bio has a commercial biopharmaceutical production facility compliant with cGMP standards.

Our site owns multiple independent drug substance production lines, equipped with:

 
  • Single-use bioreactors (up to 2,000 L)
  • Stainless steel bioreactors (up to 5,000 L * 2 )
  • Integrated chromatography and UFDF systems
  • Dedicated harvest suites with continuous centrifuge and depth filtration systems

 

Our site enables flexible phased production with multi-batch and multi-specification manufacturing capacity

DP Manufacturing

Service Scope

Jiye Bio provides sterile fill & finish services for protein/antibody products in fully compliance with cGMP requirements for Sterile Drug Product from clinical to commercial stage, supporting:

 

  • Liquid formulations (vials)
  • Lyophilized products
  • Pre-filled syringe 
  • Filling & Packaging

Facility and equipment

JIYE Bio has 2 fully automatic filling production lines and 1 pilot scale 3-in-1 multi-functional filling and freeze-drying production line.

Injectable Vial Line

Fully automated, EU-grade filling system (2R-20R vials)

Speed: 300 vials/min

cGMP-compliant sterile filling

Pre-Filled Syringe (PFS) Line

Formats: 1mL–2.25mL PFS & Cartridges

Speed: 300 units/min

Pilot-Scale Flexible Line

Integrated 3-in-1 system (filling + lyophilization + capping)

Containment: Full isolator + Grade A environment

Lyophilizer: 2 m² capacity

Compatible formats:

Nest-type vials (2R-20R)

PFS (1mL) & Cartridges

Speed: 2,250 units/hour