R&D CenterFocus on peptide industry

R&D Capability

Peptide drugs have similar characteristics to protein drugs. Compared to small molecule drugs, the process technology is complex. Although the small-scale trials are relatively easy, the scale-up effect is significant, and the technical barriers to large-scale production are high. The quality research of starting materials, intermediates, and finished products involves a wide range of content, requires a large amount of work, and is difficult to develop analytical methods. The Hotide Biotech team has gathered technical elites in various fields such as process, analysis, registration, GMP production, and enterprise management. They are skilled in the entire process of polypeptide products from laboratory to industrialization, and have the ability and experience to solve various difficult problems in the development process of polypeptide drugs. The R&D ability and product quality have been recognized by peers at home and abroad.

Technical Platform

Hotide Pharmaceuticals has established two technical platforms, namely, polypeptide drug R&D platform and advanced intermediate R&D platform.
Peptide drug R&D platform: The core members of the company have long been committed to the development of polypeptide drug production processes and quality research.
Core technologies: Long peptide R&D technology, cyclic peptide R&D technology, and polypeptide modification technology.
Advanced intermediate R&D platform: The core members of the company have long been committed to serving enterprises in the biomedical field.
Core technology: ADC/PDC linker development technology, advanced intermediate customization development technology.

High performance preparation liquid chromatograph

Dynamic axial compression column

Freeze dryer

Agilent 1260 high performance liquid chromatography

Headspace chromatograph

LC-MS for liquid-mass coupling apparatus

Ultraviolet spectrophotometer

Mettler-toledo XSR205DU One in 100,000 Balance

Gyroscope

Coulomb moisture meter

Quality System

We regards "seeking survival by quality and seeking benefits from management" as our quality policy, and has been working on the construction of a quality management system since its born. According to the requirements of ICH Q10 "Drug Quality System", a compliant and efficient R&D quality system has been established, which can run through the entire process of drug R&D, technology transfer, commercial production, and product termination.

Our quality system documents include three levels of standard management procedures (SMP), standard operating procedures (SOP), and various documents and records.

We have established an independent quality assurance department to perform functions such as change control, deviation management, CAPA management, supplier management, and product quality review management, ensuring that research and development activities are compliant, authentic, and effective.

We have established a complete training system, including pre job training for new employees, post skill improvement training for employees, GMP and ICH regulatory knowledge training, and external training.

All of the important instruments and equipment involved in the company's R&D and production activities have been qualified or calibrated.