BioDlink

BioDlink established in 2010
Listed in Hong Kong Stock Exchange (HKEX)
in November, 2019

Approaching BioDlink

With extensive practical experience, mature technical platforms and robust quality system, BioDlink has ...

ADC Integrated Platform

ADC Integrated Platform

Process and Analytical
Method Development

Process and Analytical
Method Development

GMP Manufacturing

GMP Manufacturing

Technology Transfer

Technology Transfer

Quality

Regulatory affairs

Regulatory affairs

Manufacturing Base

BioDlink is based in Suzhou Industrial Park, with a large-scale commercial production base which is in compliance with GMP standards.

News & Events

Monoclonal antibody drug substance capacity

CDMO projects collaboration

ADC drug development

ADC drug substance manufacturing capacity

ADC commercial scale batch manufacture

Commercial production of listed products

ADC Integrated Platform

Process and Analytical
Method Development

GMP Manufacturing

Technology Transfer

Quality

Regulatory affairs

Empowering pharmaceutical innovation, improving quality of life, safeguarding human health

One-stop CDMO solution

Quality management system in compliance with FDA, EMA and NMPA

Commercial GMP production for biological drugs

ADC Integrated Platform

Process and Analytical Method Development

GMP Manufacturing

Technology Transfer

Quality

Regulatory affairs

R&D, process development, and commercial manufacturing platform including mAb, DS and DP for ADC.

ADC Integrated Platform

Based on the QbD concept, BioDlink provides process development and analytical services for mAb, ADC, and fusion proteins…,etc.

Process and Analytical Method Development

BioDlink has established a large-scale commercial GMP production base for biological drugs, which equipped with multiple complete upstream and downstream production lines, and the total manufacturing capacity has exceeded 20,000 L.

GMP Manufacturing

In principle of mutual trust and reasonable control strategies, to achieve efficient technology transfer and smooth project implementation.

Technology Transfer

A GMP quality management system conforms to commercial manufacturing standards Running through from R&D to commercialization Several marketed products online production

Quality

BioDlink provides comprehensive regulatory support services throughout the entire lifecycle of products from R&D to marketing application.

Regulatory affairs

Empowering pharmaceutical
innovation, improving quality
of life, safeguarding human health

Quality management system

in compliance with

FDA, EMA and NMPA

Commercial GMP production

for biological drugs

Process and Analytical
Method Development

Process and Analytical
Method Development

A GMP quality management system conforms to commercial manufacturing standards
Running through from R&D to commercialization
Several marketed products online production