Lynn Yao

Lynn Yao

Manager, Scientific Affairs, China

三月 16, 2021

Addressing the Challenges in Research for Biologics

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.

Vials, Seals and stoppers

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:

 

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.

Recommended Blogs

色姑娘精品六 嵩明县| 栾城县| 嘉峪关市| 澄城县| 北宁市| 文成县| 祁门县| 长岭县| 微山县| 民权县| 祁门县| 屏山县| 门源| 保靖县| 沅陵县| 余干县| 庆城县| 平潭县| 蒙自县| 霍山县| 福州市| 通辽市| 绥化市| 会同县| 岳阳县| 綦江县| 旌德县| 宁阳县| 德保县| 罗平县| 濮阳县| 万年县| 惠安县| 昌黎县| 鹤庆县| 石城县| 定西市| 焦作市| 文山县| 黑龙江省| 宁阳县| http:// http:// http://