Jessie Zhang, Vice president of LinkChem
LinkChem is specialized in small molecule drug development, pharmaceutical process optimization and commercial manufacturing. As an excellent CDMO service provider, the company builds a rich experienced process chemistry team capable of carrying out nitration reactions, diazotization reactions, sodium cyanide reactions, ultra-high temperature reactions (above 250 ℃), and many special reactions in its manufacturing bases. The process R&D labs and manufacturing bases are amply equipped with international standard equipment and instruments, together adding more capability and flexibility to better meet clients’ needs.
“Focusing on CDMO services of small molecule APIs and pharmaceutical intermediates, LinkChem maintains core competencies by actively improving research and development strength, enhancing development skills and CMC capabilities, ensuring data transparency for technology transfer and data integrity, and expanding production capacities and flow chemistry platform for increasing market demand,” says Judy Lu, the CEO of LinkChem.
LinkChem makes an investment in professional resources which center around product quality, delivery speed, compliance management, and production capacity to deeply align with customer needs. The company offers cost-effective custom chemical synthesis, process development and commercial manufacturing with quantities ranging from milligrams to tonnes. The overall service process includes the signing of a confidentiality agreement, initial evaluation, development sample supply (in grams), quantity sample supply (in kilograms), batch validation, and commercial production.
The business department, R&D department, and production department are the three core departments of LinkChem’s pharmaceutical business. First, the business department obtains the demand information of customers for API and pharmaceutical intermediates. After the business department feeds back this information to the R&D department, the latter conducts feasibility analysis and quotation, and the quotation information is then fed back to the business department.
The business department confirms the information and signs the contract with the customer. When the order is confirmed, the R&D department will then conduct route exploration and process optimization and timely arrange the factory for production. After the production is completed and qualified, it shall be delivered to the customer. Throughout the whole process, LinkChem provides technical support and technical documentation for registration, while focusing on intellectual property protection.
The CDMO team of LinkChem has strong technical skills and professional capabilities with decades of experience in process scale-up, process optimization, clinical GMP, commercial manufacturing management and manufacturing validation. The management team and lab personnel show rich background in studying abroad at world-leading synthesis and analysis laboratories. LinkChem combines high technology value-added and high-barrier process development capabilities with large scale commercial production capabilities in the drug development process, making an efficient connection with pharmaceutical companies’ R&D, quality research, CMC, filing, and GMP production systems. With a global standard quality system and a customer-oriented mindset, the company is uniquely positioned to be a reliable, cost effective, and long-term CDMO partner.
Focusing on CDMO services of small molecule APIs and pharmaceutical intermediates
“Our clients’ interests always come first. We keep providing high-quality integrated chemical services to meet our clients’ chemical requirement including novel building blocks supply, FTE/FFS, Process development and optimization, CMC, commercial production in the small molecule drug field,” says Lu.
Now, green Chemistry is more important than ever before and Continuous flow technology can improve the level of drug production from several dimensions, such as efficiency, cost quality and environmental protection, and promote the safe, efficient, high-quality and green development of the pharmaceutical industry.
“LinkChem is working on building such flow chemistry platform to enhance our Enhance our competitiveness. Adhering to the spirit of continuous contribution to life and health and green energy innovation, LinkChem will continue to take the research, development and industrialization as an overall long-term development of the cause!” says Lu.