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Sterile Drug Product Production Service
The drug product workshop of Yaohaibio covers an area of 2,000 ㎡ for sterile drug product (DP) manufacturing, enabling automated production services. The automated production line integrating multiple processes such as vial washing, oven drying, sterilization (depyrogenation), filling, lyophilization, and capping, conforming to the production requirements of sterile drug product of China NMPA, EU EMA, and US FDA. Experienced in sterile biological drug production, we provide high-qualified services from small-scale clinical sample production to large-scale commercial vial filling and PFS production.

  • Maximum annual output of injection: 10 million vials
    Maximum annual output of lyophilized powder for injection: 5 million vials

  • Maximum annual output of pre-filled syringes and cartridges: 8 million

  • IND, phase I/II/III clinical trial, and commercial production

  • Fully arrange the production lines for injection, lyophilized powder, and pre-filled syringe products

  • Types of filling products: mainstream biological products such as recombinant proteins, peptides, plasmids, antibody and vaccines, etc.

Injection (vials) and lyophilized sterile drug product production lines
Injection (vials) and lyophilized sterile drug product production for biological products
Filling specification range

1ml-25ml


Sterile production line

O-rabs system to protect the Grade A environment in the product (and packaging materials) exposure area

Fully automatic feeding and discharging system

Fully automatic SIP/CIP system of lyophilized machine

Online nitrogen charging system for nitrogen filled protection

PMS online monitoring system


Filing Precision

High filling percision: (filling medium: water for injection) ± 0.25%


Filling speed

The maximum production speed is 300 vials/min, and the maximum lyophilization batch is 37800 vials /batch, calculated based on the 2ml vial


Sterile drug product production line for PFS/cartridge product
Production of sterile drug products with PFS syringes and cartridges
Filling process

Support plunger pump and peristaltic pump, as well as vaccum filling, satisfy the filling process requirements of different preparations


Filling specification range

Prefilled syringe: 1ml and 3ml, cartridge: 3ml


Filling percision

Filling percision of 0.2-0.5ml is ± 3%

Filling percision of 0.5-3ml is ± 2%


Sterile filling

Various drug liquid filling methods (normal filling, nitrogen filling, vacuum filling)

Vacuum stoppering method, applied to various rubber stoppers process

O-rabs system to protect the Grade A environment in the product (and packaging materials) exposure area

PMS online monitoring system to facilitate the real-time monitoring of production environment and quick detection of environmental abnormalities


Production capacity
  • 10 million vials
    (Annual production)
    Specification: 1ml-25ml

    Injection (vials)

  • 5 million vials
    (Annual production)
    Specification: 1ml-25ml

    Lyophilized powder for injection (vials)

  • 8 million vials
    (Annual production)
    1ml and 3ml

    Prefilled syringe/cartridge

Focus on
microbial expression system
CDMO service leader

CONTCT US

TEL: +86-523-86285566

Address: Building 29, No. 801, Jiankang Avenue, Taizhou, Jiangsu

Email: BD@yaohaibio.cn

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