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With more injectable biologics coming onto the market, and an increase in combination products, regulatory scrutiny is being given to the interaction between a drug product and its container closure system. If the right container closure and device are not selected for a biologic that is marketed in a prefilled syringe or auto-injector, there could be a significant impact on quality.
Incompatibility between a drug and its container closure system could present risk of:
Any of these issues could potentially compromise patient safety. They could also lead to a delay in regulatory filing, increased program costs and loss of market share. As more attention is paid to the integration of primary drug containers and drugs with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products especially complex higher viscosity biologics.
Choosing the right components for a prefilled syringe fit for an auto-injector is a key part of ensuring drug quality and safety. Plunger design, dimensions, sterilization technique and the type of lubrication coatings all impact the performance of a drug delivery device.
At West, patient needs drive quality in all of our components. High-quality NovaPure® components are designed for biologics and sensitive drug products and provide optimized performance for use in prefilled syringes and auto-injection systems. We develop our NovaPure® plungers and stoppers with holistic Quality by Design principles around patient needs to help ensure the efficacy and purity of a drug product and with the patient.
As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
In recent years, there has been a shift in the pharmaceutical industry toward a Quality by Design (QbD) philosophy. To maximize a drug product’s safety and efficacy, pharmaceutical companies and their drug packaging and delivery partners are building new quality principles into the entire manufacturing process, from design and development to commercialization and administration. This scientific, risk-based QbD approach is fast becoming an essential strategy for bringing high-quality therapeutics to market quickly and efficiently.
The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment for more conditions, including asthma and cholesterol problems.
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