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, where our production capacity is 500,000 liters/year for liquid media and 1,300 tons/year for powder media, with the largest batch of powder media being 2.6 tons (100,000 liters). We completed the process validation for scaling up our automatic, low-temperature cone mixing/pin milling (CMPM) processes at the 1,000L, 10,000L, 100,000L scales, ensuring the stability and reliable quality of our culture media. Our manufacturing site implements information management to guarantee the accuracy and reliability of our data to meet relevant requirements of the quality management systems across the world. We also established a comprehensive quality inspection and management system for the supply of raw materials in accordance with GMP audit requirements. We follow the “2 local +1 imported” raw material supplier model, achieving the domestic substitution for more than 80% of raw materials required for serum-free media production, ensuring stable and rapid production and supply, minimizing the impact of import and export trade.

Phase II Manufacturing Site - Shanghai Beijin Biotech Co., Ltd

Construction/Cleanroom area: 10000/3000 ㎡

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

introduction

OEM Service

Sample Production Workflow

Signing Confidentiality Agreement

Signing Confidentiality Agreement

01

Formulation Confirmation

Formulation Confirmation

02

Raw Material Confirmation & Procurement

Raw Material Confirmation & Procurement

03

Scheduling

Scheduling

04

Detection

Detection

05

Delivery

Delivery

06

OEM Workflow

Project Approval

Project Approval

VOC

Develop project plan

01
Development

Development

PDS/SPC

RMS

TM

HOQ

d-FMEA

02
Process Research

Process Research

PPU

PS

HOQ

P-FMEA

03
Process Validation

Process Validation

PQ

Field Test

p-FMEA

VSM

CTQ CPK

Preparing the Product Launch Documentation Package

04
Professional Cell Culture Solutions for Biopharmaceutical Development

Our expert scientific team delivers end-to-end cell culture services to support your biopharmaceutical production needs. We provide comprehensive solutions including:
- Process development & optimization
- Customized medium formulation design
- Scalable medium processing & GMP manufacturing

For technical inquiries or service requests, please submit your message through our [Quick Message] portal. Our specialists will respond within 24 business hours.

For urgent matters, please contact +86 137 5514 6322 directly