As an experienced commercial manufacturer, LinkChem can provide one-stop outsourcing intermediates services of process route development and verification, analysis method development and verification, process improvement and application registration to help customers with investigational to commercial-scales developments. The development services include a large number of raw materials, registered starting materials and GMP advanced intermediates throughout the entire drug development process.

With our strong and diverse infrastructure, LinkChem facilities are multipurpose and flexible and allow a rapid response to meet customer requirements. LinkChem have the advantage in the field of Heterocyclic Chemistry, chiral drugs, Carbohydrate chemistry, Nucleoside chemistry, Peptide Chemistry and Antibody Drug Conjugation (ADC).

LinkChem’s factory workshop has good versatility, flexible capacity of rapid switch and project management mode to ensure that the production and operation system can quickly and high-quality delivery of products and services required by customers.

Relying on the international standard quality system and large-scale commercialized GMP product production experience, we can provide customers with high quality commercialized API and GMP intermediate products at the optimal cost, and provide customers with a series of additional services such as secondary process development and optimization. LinkChem has different types and different sizes of plants, which can achieve the perfect combination of laboratory scale to commercial production scale and ensure the stability of supply.

 

Development and optimization of innovative process routes

Production of API/intermediates

Synthesis and manufacture of building blocks

Development and process optimization of preclinical candidate compounds

 

Process optimization of designated routes

Production of Special chemicals

GMP/Non-GMP production of intermediates

Synthesis of high-quality kg scale samples

Service Platform: XFlow Chemistry is committed to building the flow chemistry platform using the industrial continuous flow reaction technology, adhering to the concept of green and safe production, providing customers with continuous flow process design, process optimization, laboratory testing, feasibility study, equipment improvement, process development as well as fully integrated solutions to better meet the needs of customers in large-scale, sustainable production.

Reaction Types for Flow Chemistry Applications

Nitration reaction (concentrated sulfuric acid, dichloroethane)

Sulfonation reaction

Chlorination reaction (photocatalytic, thermocatalytic)

Amination/Reductive amination reaction

High-temperature and high-pressure reaction

Metal reagent reaction (butyl lithium, Grignard reagent, DIBAL-H, etc.)

Diazotization reaction, diazonium salt hydrolysis

Oxidation reaction (hydrogen peroxide/Swern/peroxycarboxylic acid/ozone/air/nitric acid)

Esterification reaction

Azide reaction

Gas-liquid reaction

Continuous Production Technology Development

Regular products + Continuous flow process

Complete line (multi-step reaction) of continuous technology process

Continuous reaction - extraction and washing - evaporation and crystallization - distillation and concentration

New Catalyst Technology + New Reactor Technology

Application of new technologies such as solid super acids, ionic liquids + Continuous flow technology

New process + New equipment

Reduce overall costs and achieve intrinsic safety

Feasibility Assessment of Continuous Reactions

Process development and optimization

Validation and scale-up

Generation of technology packages

Technology transfer to production

Continuous process improvement

Process optimization at laboratory, kilogram and commercial production scale

Route Screening &process optimization of APIs

Study of complete impurities of APIs

Polymorph, salt and co-crystal screening of APIs

Crystallization processes of API and intermediate for scale-up, control of polymorph and particle size

Technical pack of intermediates support

On-site audit

IND/NDA/ANDA regular filling support

Design, Process research and Development of New Materials

With the Strong R&D teams, LinkChem can provide custom service of design, process research and development of new materials including:

Lithium Battery Material

Photoelectric Materials

Semiconductor Materials

PI Monomer

Fluorine Materials

Noble Metal Catalysts

Commercial production of new functional materials and intermediates

Based on a sound production system supporting by Fujian plant, Shangdong plant and Jiangxi plant, LinkChem Co.,Ltd. can support production of new materials and intermediates.

Fujian plant can make use of local abundant fluorine resource and raw materials easily available, and are especially suitable for development and production of fluorinated functional materials

LinkChem can provide customers with all kinds of new materials project industrialization.

 

Quick analysis for new drug substance

Analytical support for process research

In process control and release test

Analytical method development, method validation and qualification

Elemental analysis and method development

Genotoxic impurity method development and validatio

Residual solvent method development and validation

Reference standard characterization and qualification

Impurity isolation, identification and characterization

Stability studies for drug substance