In the development of innovative drugs, the progress of the process development of the IND phase of the API often directly affects the subsequent formulation development, preclinical and clinical research, and final commercialization. How to plan and manage the API process development in the IND phase, and how to do the quality control of the API process in the IND phase, is very important.
On April 9th, 2020, Medicilon launched the online live course lecture 07. Dr. Luo Wanrong, senior director of the process department of Shanghai Medicilon Biopharmaceutical Co., Ltd. gave a special report “How to do well in the API process of the IND stage of new drugs R&D? “.
Dr. Wanrong Luo, Senior Director of Medicilon’s Technology Department, joined Medicilon in 2011 and has long been engaged in API process research and has extensive experience in API project development, process transfer, scale-up production, and registration. During his time at Medicilon, he was engaged in more than 30 category 1 new drug process development (IND), of which 17 varieties were approved for clinical trials.
Introduction of Medicilon Craft Department:
The current total area of Medicilon Technology Department is about 6000 square meters, including 2000 square meters R&D laboratory, 800 square meters non-GMP pilot scale-up workshop, 1000 square meters GMP API workshop, 1000 square meters analysis and testing center, 800 square meters GMP-compliant QC laboratory, 200㎡ microbiology laboratory.
The experimental equipment is complete and the technology is advanced. The main equipment includes different types of glass reactors, rotary evaporators, stainless steel reactors, vacuum drying ovens, blast ovens, temperature control units, precision filters, two-in-one filters, and centrifugals. Machine, jet mill, turbo mill, etc.
The main analytical instruments include UPLC, HPLC, GC, IC, LC-MS, GC-MS and other chromatographic analyzers, as well as laser particle size analyzer (PSD), constant temperature and humidity test chamber, differential scanning calorimeter (DSC), Thermogravimetric analyzer (TGA), X-ray powder diffraction (XRPD), nuclear magnetic resonance (NMR), Fourier transform infrared spectroscopy (FT-IR), ultraviolet spectrophotometer, polarimeter, muffle furnace, melting point meter, moisture Tester (KF), conductivity meter, TOC and ICP-MS, etc.
Medicilon has a GMP production workshop and established a GMP-compliant API workshop. At the same time, it has improved the level of drug production and quality management systems. It can provide customers with customized services for GMP production and help more R&D companies carry out actual technology transformation. Shorten the time to market and promote commercialization.
Medicilon’s Process Department can not only carry out the research and development, inspection and stability research of generic drugs for customers, but also carry out the research and development, production, inspection and stability research of the clinical phase I and phase II of innovative drugs, gradually developing from process research and development to industry Commercial production, transforming from CRO to CDMO.