Manager, Scientific Affairs, China
March 16, 2021
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:
- due to the diversity and complexity of biologic drugs, risk assessment and control should be carried out according to individual characteristics
- based on the concept of "Quality by Design (QbD)", companies should conduct full process development and comprehensive quality studies, summarize the impact of production materials and production process on quality, perform analysis of the correlation between drug quality and clinical safety and efficacy, and establish the concepts of a whole process quality control system and a whole life cycle management.
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:
- extractables from stoppers that can leach into drug products
- sensitivity of biologic drugs to silicone oil (e.g., can cause proteins to aggregate) used to lubricate stoppers for easier fill/finish
- proper matching of vial, stopper, and seal to ensure container closure integrity (CCI)
- CCI challenges at low temperature storage
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:
- SCHOTT glass vials or Daikyo Crystal Zenith® vials, available in multiple sizes
- vision-verified NovaPure® stoppers with FluroTec™ barrier film
- Flip-Off® Clean Certified Sterile (CCS) seals
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.