High-end preparation / chemical synthesis

Preparation / production

Ganglu provides customers with preparation and quality research services such as synthesis process optimization, synthesis route determination, preparation process research and therapeutic materials  quality research. The types of therapeutic materials  range from patent products to generic products. All studies are carried out in accordance with ICH and CFDA guidelines.

Experts in:

Study on synthesis process

Determination of synthetic route

Synthesis process optimization

Scale-up of synthesis process

Study on formulation technology

Study on Preparation Technology

Pre-formulation study

Formulation screening

Process optimization

Internal and external research

Process scale-up

Quality analysis and research

Establishment of analytical methods for APIs, impurities, isomers and preparations

Study on the stability of analytical method

Validation of analysis method

Quality standard Determination

Stability study

Follow ICH and CFDA guidelines

Long term stability test and accelerated test

Special synthesis

Recombinant protein

Antibody preparation

Antibody modification

Primer design

Nucleic acid synthesis

Ingenuity and excellence