Products
BioEngine has developed nearly 100 types of serum-free media for different cell lines, which are suitable for antibodies, vaccines and cell and gene therapy (CGT) fields.
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.
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
Signing Confidentiality Agreement
01Formula communication and qualification
02Raw material qualification/procurement
03Scheduling
04Detection
05Delivery
06VOC
Develop project plan
PDS/SPC
RMS
TM
HOQ
d-FMEA
PPU
PS
HOQ
p-FMEA
PQ
Field Test
p-FMEA
VSM
CTQ CPK
Preparing the Product Launch Documentation Package
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.
3F&4F, Building 3, Lane 396, Lvzhou Ring Road, Minhang District, Shanghai, PRC