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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.
Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent <a href="http://www.nature.com/clpt/journal/v93/n2/full/clpt2012220a.html"><span style="color: #0000ff; text-decoration: underline;">paper</span></a>, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur. In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
At the 2013 Drug Delivery Partnership conference, West’s Bart Burgess partnered with Peter Krulevitch, Ph.D., Engineering Director, Packaging, Devices & Delivery, Janssen Pharmaceutical Companies of Johnson & Johnson to discuss West and Janssen’s unique partnership. Together, West and Janssen are developing the SelfDose<sup>TM</sup> injector platform technology.*
West will be exhibiting at the Partnership Opportunities in Drug Delivery (PODD) Conference on October 14-15, 2014 at the Renaissance Boston Waterfront Hotel. West’s Zach Marks will be presenting an overview of the SmartDose® electronic wearable injector.
In recent years, there has been an increase in the use of multi-dose vials. First, multi-dose vials can create efficiency and reduce packaging waste when vaccines are administered to large populations. For example, both the Pfizer-BioNTech and Moderna COVID-19 vaccines provide multiple doses per vial to maximize the number of people vaccinated as quickly as possible. Secondly, multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight. This also applies to the animal health sector to accommodate the large diversity across different species, dosage differences, and use of various needle gauge sizes.
Market trends toward home use and patient self-administration of drugs used to treat chronic conditions (e.g., multiple sclerosis, rheumatoid arthritis and autoimmune) have made prefillable syringe systems an ideal choice for single-dose drugs. Prefilled syringe systems for vaccines, pharmaceuticals and biopharmaceuticals offer convenient, fixed dosing and are adaptable to automated injection devices.