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By Your Side for Optimal Patient Outcomes – A Quality Perspective
In order to ensure the best quality drug product and optimal patient outcomes, it’s important for drug manufacturers to foster a collaborative effort with their packaging suppliers from the beginning – and that means starting with the patient in mind. Understanding patient needs and how that drug will be delivered, whether through one of West’s delivery devices or some other device, will help determine the needs within the West manufacturing process.
By working by the side of our customers early in the drug development process, we are able to clearly understand what the specific containment and delivery requirements are for their drug product and select the appropriate packaging and delivery systems and materials. These early conversations allow us to align capabilities across the globe to meet high-quality expectations throughout the entire manufacturing process.
For example, we need to consider the particle load throughout the supply chain – including other facilities, materials and processing involved in the production and delivery of the drug product – to ensure that we’re mitigating any additional burden that may exist later in the process that could impact the final quality. West takes an active role in supporting our pharmaceutical partners in this process, working collaboratively to develop a solution for the total supply chain.
In addition, quality standards are incredibly important when it comes to the combination of emerging drug molecules and delivery devices. Previous standards didn’t necessarily take into account the unique containment needs of biologics or other large molecule drugs. Additionally, old standards didn’t address the total drug containment and delivery system, but instead focused on individual components, such as stoppers and vials. It’s a completely different supply chain, and the standards need to be updated to address the needs around current drug molecules and delivery systems as well as future therapeutic offerings.
Working by the side of our customer, we can ensure that patients are always in the forefront of the production process, and that the quality of our manufacturing reflects the need for optimal patient delivery. When we understand better how our products will be used and what’s needed to align the capabilities, we can meet or exceed the quality expectations needed for our customers and ultimately the patient.
Modern biopharmaceutical drug molecules are often complex protein structures that need to maintain the molecular structure in order to convey full potency. With biologics, any alteration of the 3-D structure could lead to loss of activity or even to immunogenic reactions in the patient. Proteins can be disrupted by interactions with the container closure or with leachables. West FluroTec® lamination was chosen for NovaPure® plungers to reduce the interaction between the drug product and elastomer material. This includes less adsorption to the plunger surface as well as reduction of the leachables profile of the plunger, helping to maintain the stability of complex molecules.
When evaluating the vial system for your drug product, how do you know you’re making good decisions about protecting the drug product while also meeting regulatory expectations for data requirements as outlined in ICH Q9? To illustrate how complex it is to determine how much data is enough to make good, sound, decisions on your vial containment system, two 20mm container closure systems (CCS) were evaluated with the primary difference being the hardness of the rubber vial stopper. The designs were identical for each stopper, meaning the specifications, nominal dimensions, and other major features were the same.
Anthony Bucci
Principal Engineer, Scientific Affairs, West Pharmaceutical Services
Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products (> 400 FDA-approved); because absent water, the rates of degradative processes are reduced substantially. Essential to successful lyophilization, and subsequent rehydration, are use of proper containment and reconstitution systems. <br />
West is pleased to announce the availability of a new sterile drug vial seal, the Flip-Off<sup>®</sup> Plus<sup>RU</sup> seal. Part of West’s Flip-Off® seal product family, these new ready-to-use seals help pharmaceutical and biopharmaceutical manufacturers protect the safety and integrity of their drug products while meeting regulatory requirements for increased drug cleanliness and safety.
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.