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OEM
Introduction

BioEngine has the leading capability to produce high-performance and high-quality serum-free culture media. With its strong production capacity, BioEngine can provide a more competitive price to customers, whose medium production capacity is 250,000 liters/year for liquid, 1,300 tons/year for powder, and 2.6 tons (100,000 liters) for the largest batch of powder. We have completed the verification of the amplification of the low-temperature CMPM process for the 1,000-liter level, 10,000-liter level, and 100,000-liter level, which ensures the stability and reliable quality of the culture media products. The production base implements information management to ensure the accuracy and reliability of data and to meet the relevant requirements of major quality systems in China and abroad. We have also established a complete quality inspection and management system of raw materials in accordance with GMP audit requirements and formed the strictly selected "2 local suppliers +1 foreign supplier" raw material supplier model, achieving the substitution of more than 80% of the raw materials of serum-free medium by local ones to ensure stable and rapid production and supply without the influence of import and export trade.

Phase II production base of BioEngine - Shanghai Beijin Biotech Co., Ltd.

Construction/Cleanroom area: 10000/3000 m2

Production line and capacity: 5 Powder culture medium production lines (100,000, 10,000, 1,000, 100 L/batch) + 2 liquid culture medium production lines (1,000, 100 L/batch)

Mode of Production: Automatic and information-based Cone Mixing/Pin Milling (V2.0)

Quality System: ISO13485:2016&FDA&GMP

Address:Building 5, No.1438 Jinliu Road, Jinshan District, Shanghai

OEM Service Process
Sampling Process
  • Signing Confidentiality Agreement

    01
  • Formula communication and qualification

    02
  • Raw material qualification/procurement

    03
  • Scheduling

    04
  • Detection

    05
  • Delivery

    06
OEM Work Flow
  • Project Approval

    VOC

    Develop project plan

    01
  • Development

    PDS/SPC

    RMS

    TM

    HOQ

    d-FMEA

    02
  • Process Research

    PPU

    PS

    HOQ

    p-FMEA

    03
  • Process Validation

    PQ

    Field Test

    p-FMEA

    VSM

    CTQ CPK

    Preparing the Product Launch Documentation Package

    04

Let us contact you

We have a professional technical team to provide high quality one-stop cell culture service from process development
and optimization, medium formulation design to medium processing and manufacturing for all biopharmaceutical companies.

If you have any question, please click "Quick Message" and leave your message,  we will reply to you as soon as possible.
If anything urgent, please call (86)21-68582660-2792.

BioEngine

3F&4F, Building 3, Lane 396, Lvzhou Ring Road, Minhang District, Shanghai, PRC

(86)21-68582660-2792

globalsales@bio-engine.com.cn

Work hours:9:00-17:00