Macromolecule Drug CDMO Platform
1. Platform Overview
Macromolecular platforms comply with GMP Standards of US FDA、EU EMA and NMPA of China. It equipped with 500L/2000L scale production line (designed by NEPHARM, with cGMP standards, equipped with Sartorius Bioreactor, Millipore System and GE Purification System, Bosch washing & drying & irrigation & rolling linkage line, 3M sterilization cabinet and Schneider SCADA Automation Control System).
The core personnel of the platform operation team have more than 15 years work-experience in Internationale-leading pharmaceutical and biotechnology companies such as KANGHONG, INNOVENT and Bristol-Myers Squibb, and have rich experience in process development and scale-up, process control and quality control, project management, etc., and have experience in the marketing and R&D and production of 8 biological drugs.
The platform can provide stable cell line screening, pilot fermentation process, large-scale culture process and macromolecular purification process development services, antibody drugs, recombinant protein drugs, protein vaccine pilot and large-scale production services and other biological macromolecular pharmaceutical preparations production technical services, support products in China, United States, Europe and other places to conduct clinical trials and rapid marketing, and achieve global synchronous transformation of customer research results.
Small Molecule Drug CDMO Platform
Zhengzhou Pioneerpharm Pharmaceutical Co., Ltd. (Small Molecule API & Preparation CDMO Platform) is an organic part of the Lifezhengzhou · Leadingpharm CXO System. It is jointly built by Leadingpharm, Beijing Chempion Biology and Lifezhengzhou Biomedical Park, provideing technical services related to small molecule industrialization and clinical sample preparation for national pharmaceutical enterprises.
The platform complies with GMP standards of FDA and NMPA, with a total construction area of 6651.54㎡. It is equipped with three preparation workshops (oral solid preparation workshop, small volume injection workshop and oral solution workshop), with supporting power center, storage, quality inspection and other institutions or facilities.
The platform provides a qualified site for the production of clinical samples of innovative drugs, commercial production of rare disease drugs, pilot test and commercial production of imitation drugs. The dosage forms include tablets, capsules, granules, oral liquid, small volume injection and other conventional oral and injection dosage forms.
The platform can produce 200 million preparation units of solid preparations, 15 million preparation units of injections, 12 million preparation units of oral liquid, 60 pilot projects and 1000 batches of testing per year, enabling innovative enterprises to break through bottlenecks and grow at a high speed.