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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.
In determining extractables from parenteral drug packaging systems, the FDA is clearly looking for appropriate choices of solvents, times, temperatures and other conditions that could impact the results of studies. The outcome of the studies should support the intended purpose – to allow for practical correlations and design of leachables studies.
“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.<sup>1</sup>
The need for <a href="/sitecore/service/notfound.aspx?item=web%3a%7b8E02CCA4-F229-4EDC-93A4-6A837E7FA55E%7d%40en">advanced containment solutions</a>, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.
Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.
The manufacture of polymer containers for parenteral drug products differs from that of glass and elastomers and must combine the common manufacturing methods below to meet the needs of the pharmaceutical market.
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