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When you think of injectable medication, a classic image may include a set of hands holding both a vial and a syringe to withdraw medication prior to injection. Advances in both drug products and self-injection options – including auto-injectors, pens and other self-injection devices – have helped to draw a new picture for injectable delivery.
While vial containment is still a preferred container for many injectables, the use of a glass or polymer prefilled syringe (PFS) offers a variety of benefits, including ease of use thanks to a reduction in steps, less over-fill volume of the drug product to help reduce cost per dose, and a more precise dosage to help ensure patient safety. Along with the rapid growth in biologic medicine, technical advances in containment and a rising patient preference for easy to use options for self-administration, these benefits have helped to fuel market growth for prefilled syringes.
Whether preparing for clinical trials or preparing for drug product launch, different containment options may be needed to align with drugs in the pipeline. Characterization and qualification of a variety of options can help to solve the containment conundrum and ensure a smooth transition from R&D testing, through clinical trials to commercial scale up. Partnering with an expert in containment solutions and analytical testing can help ensure that the limitations of a drug product are known, and can help to characterize and qualify a proper system that can be used throughout the drug product lifestyle.
When characterizing a system, pharmaceutical manufacturers must first look at the needs of the drug product itself and then the needs of the delivery system. For example, a drug product may be compatible with glass for primary containment, but the dose delivery requirement via an auto-injector may demand a force that would damage the syringe. In such a case, a cyclic olefin polymer (COP) may offer the advantage of strength, tighter tolerances and improved functionality.
The below activities summarize the process for selecting and qualifying components for a PFS system.
- Preliminary Assessment
- To define the drug product requirements, critical quality attributes, and target delivery system
- Verification
- Dedicated to process development, design controls, and ensure drug and delivery system requirements are met
- Implementation
- Scale up, process transfer to commercial state, and verification of drug delivery system
- Ongoing Support
- Supply chain and inventory strategy planning, on-going regulatory support, and documentation to support Drug Master File and Design History File
As the industry continues to see growth for products developed in PFS, pharmaceutical companies require deeper understanding of the drug delivery system as a whole, especially as the number of biologics in development continues to increase. While this blog is a summarized review of the four-stage process for selection of a PFS system, it provides an overview of how working closely with supplier partners during PFS system selection can help mitigate risk during development. An integrated approach from R&D to clinical and commercial scale up is a best practice regardless of which delivery system is selected for a given drug product.
Click here for more information on West’s Integrated Solutions for PFS systems.
While you won’t see cats on vacuums, cute dogs doing crazy tricks or any dancing toddlers, the <a href="http://www.youtube.com/user/WestFYI"><span style="color: #0000ff; text-decoration: underline;">WestFYI YouTube Channel</span></a> does offer a variety of product videos to help customers and potential customers learn more about West’s products and our company.
Particles in parenteral drug products are a serious concern; they can cause issues such as product recalls, or worse, immunogenic responses. Sources of particles are varied; they can be from aggregates of biologic API’s, excipient contaminants, components, or silicone oil used to promote syringe function. With emphasis on safe and efficient delivery of drug products, West is focused on strategies to both measure particles, and mitigate their presence.
In May of 2015, Exton announced their West Without Borders focus on the Year of the Veteran, with The Travis Manion Foundation named as one of the recipient charities.
Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?<br />According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.
<em>Since 2007, West team members in Jersey Shore and Williamsport, Pa., have donated to Camp Victory, helping to beautify the grounds each year, build a wheel-chair accessible tree-house and provide funding for the summer camp experience of a lifetime for children with illnesses. For West’s Jeff Adams, </em><em class="ms-rteThemeForeColor-2-2">Supply Chain Manager/Lean Leader</em><em><span class="ms-rteThemeForeColor-2-2">,</span> Camp Victory has also been a place his family has experienced as both volunteers and campers.</em>
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