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CXO

Committed to the development and innovation of first-class drugs

CDMO







 

Small Molecule Drugs CDMO Platform


Ⅰ Platform Introduction

  Zhengzhou Pairui Pharmaceutical Co., Ltd. (Small Molecule API- Preparation CDMO Platform) is an integral part of the Lifezhengzhou-Leadingpharm CXO System,  jointly built by Beijing Leadingpharm, Beijing Crown Biology and Zhengzhou Lifezhengzhou Biopharmaceutical Park, to provide small molecule  industrialization and clinical sample preparation-related technical services for national pharmaceutical enterprises.

 

  Service: The platform provides a compliant site for clinical sample production of innovative drugs, commercial production of rare disease drugs, and pilot and commercial production of generic drugs, including tablets, capsules, granules, oral fluids, small-volume injections and other conventional oral and injectable dosage forms. The project can produce 20 million preparation unit solid preparations, 15 million preparation unit injections, 12 million preparation units oral fluid, 60 pilot projects and 1000 batches of testing, can all-round enabling innovative enterprises to break through the bottleneck of high-speed growth.

 

 Ⅱ Platform Function Introduction

       The platform is made up of 4 floors, with a total construction area of 6651.54 square meters

 

  

 Ⅲ Platform Hardware Introduction

  The platform conforms to the U.S. FDA, China NMPA GMP standards. There are three preparation workshops (oral solid preparation workshop, small-capacity injection workshop, oral solution workshop), with supporting power, power center, storage and quality inspection and other institutions or facilities.

Large Molecule Pilot and Large-Scale Production Platform

  I Platform Introduction

  The large molecule pilot and large-scale production platform is a CRO/CMO platform for macromolecular drugs that meets the FDA, EMA and NMPA GMP standards. It aims to provide integrated CDMO services for the development and production of biological macromolecular drugs.

  Service: Stable cell line screening, pilot-scale fermentation process, large-scale culture process and macromolecular purification process development services, antibody drugs, recombinant protein drugs, protein vaccine pilot-scale and large-scale production services, production technical services for biomacromolecule drug preparation, support products to conduct clinical trials in China, the US, Europe and other places and quickly go to market, realizing the global synchronization of customers' research results.

   II  Platform Function Introduction

  The platform has 4 floors and a total construction area of 11453 m2.

  III Platform Hardware Introduction

  Pilot process development laboratory, 500L/2000L scale production line (NEPHARM team design, cGMP standard, equipped with Sartorius bioreactor, Millipore three filtration system and GE purification system, Bosch washing-drying-filling-rolling line, 3M sterilization cabinet and Schneider SCADA automation control system)

Cell Rrugs CDMO Platform

  

 Ⅰ Platform Introduction

  The cell technology service platform complies with FDA, EMA and NMPA GMP standards, and can meet the needs of small-scale, pilot-scale and commercial production of cell and gene drugs.

  Service:full-process CDMO services for cell and gene drugs (plasmid, virus, cell drug form)-small test, pilot test, preclinical research, IND registration, clinical trial and commercial drug production, stem immune cell storage, development and testing of quality testing indicators, and can provide medical institutions, R&D institutions with spot supply of plasmids, lentiviral vectors and preparation services of cell preparations.

  

 Ⅱ Platform Function Introduction

  The platform has 4 floors, with a total construction area of 6651.54m2.

  

 Ⅲ Platform Hardware Introduction

  The production workshop includes 2 GMP cell preparation production lines (automatic line, manual line), 1 plasmid production line, 3 virus production lines (lentivirus, oncolytic virus, adeno-associated virus), as well as sub-assembly lines, water production and gas supply, etc.; Storage, cell storage, medical waste temporary storage, medical technology cell preparation (P2 biosafety level), etc.; R&D office includes QC testing room, PD laboratory and office.