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In recent years, an increasing variety of biologic drugs have been developed including vaccines, recombinant proteins, gene and cell therapies. In China, this increased demand will be reflected in a significant growth in the size of the bio-pharmaceutical industry. As a result, the Chinese government is increasing its investment.
To provide guidance for research on biologic drugs, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) has recently published a series of exposure drafts on technical guidelines for bio-pharmaceutical research and evaluation. These drafts adopt the principles of quality risk management, which is a systematic process used to assess, control, communicate, and review the quality risks of a drug throughout its life cycle. In particular, these drafts specify that:
With a focus on minimizing risks, West thoroughly understands the vial systems used in biologic drugs, as well as the following issues that require consideration:
Based on this understanding, West offers the Ready Pack™ containment system – an ideal solution to help bio-pharmaceutical companies quickly address the above points, so as to get their drugs to market faster. The Ready Pack system includes:
For more information on the Ready Pack system click here or contact an Account Manager or Technical Customer Service (TCS) representative.
Ready Pack™, NovaPure®, FluroTec™ and Flip Off® are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec™ technology is licensed from Daikyo Seiko, Ltd.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.