The number of clinical trials using prefilled syringes continues to rise. From just a handful of studies testing drugs with the devices 10 years ago, the number increased to 54 studies in 2015, according to a data search of trials in clinicaltrials.gov.
This growth includes studies conducted internationally and can be attributed primarily to the rapid expansion of large molecule biological drugs in development. However, prefilled syringes are also increasing in popularity because they represent improved safety, accuracy and ease of use compared to conventional vial and ampoule packaging.
Join us 03 November 2016 for an Xtalks webinar to learn how clinical supplies professionals are working behind the scenes to bring these complex devices through clinical development. “Key Tips to Sharpen Your Clinical Trial Packaging Strategy for Prefilled Syringes” is presented by Fisher Clinical Services, a leading global provider of clinical trial supply services. Our two speakers have extensive engineering backgrounds in syringe assembly development, including the design of patented blinding and packaging systems.
Key Learning Objectives:
- Determine the best prefilled syringe packaging strategy based on your component configurations and clinical trial designs
- Prevent prefilled syringe assembly from adding delay to your clinical supply chain
- Acquire syringe assembly and labeling insights from experienced clinical packaging engineers based in the U.S. and Europe
What would you like to know?
To help us shape this Xtalks webinar, you will be asked some questions during registration. We invite everyone interested in supply partnerships to attend, no matter your level of experience with prefilled syringes. Here are a few questions we will address during the webinar.
1. What components do you expect will be most troubling?
The value of the device is in how effectively its components work together. Since the plunger rod and stopper function as both container closure and drug delivery they might present the largest headaches, especially when considering rotational torque during assembly. Needle safety devices (NSD) may raise additional issues. Some syringe barrels require high precision labeling to apply graduation marks. Clearly, manufacturing complexity of prefilled syringes has increased along with their functionality.
2. What are the anticipated lead times, volumes, and investments?
Projects that need to deliver drug to patients in 6 weeks will have a different flavor than those with a 6-month timeline. Both milestones are achievable; it’s just that the solutions will vary. Also variable are the planning details for projects that call for 10,000 syringes over the life of the study versus those that require 100,000 or even 1,000,000 syringes. Volumes are tightly connected to investment expectations, of course. But there are various approaches to meet these volume needs based on available financial and staffing resources. Note that concerns about capacity or production redundancy are alleviated thanks to the global infrastructure at Fisher Clinical Services.
3. What cold chain requirements are driving your project?
Time out of refrigeration, also known as time out of environment, has grown to be a crucial metric in clinical supply management due to the growth of biologics. To protect the shelf life of cold chain products, Fisher Clinical Services offers assembly and labeling system in refrigerated packaging rooms. A new fully automated system will begin cold room operation in early 2017. Considered the first system of its kind in the industry, the cold room syringe line may suit a range of projects and will operate in 2°- 8°C or 25°C / ambient.
4. What’s your approach to development?
Some prefilled syringe supplies projects operate within narrow guidelines. These are similar to commercial scale engagements with tight control over work flows and review. Other projects take a more open approach to developing the process. And most are somewhere in between these two extremes. Yet all can have equally high levels of quality. They differ only in the means to achieve this end.
Thank you for considering these questions. We look forward to your answers as we build our presentation to address your needs. Please make time to join us live 03 November 2016. Plan on an informative and interactive session, complete with case study examples of our past syringe work. Give your next prefilled syringe project a shot in the arm!
Keywords: Cold Chain, Clinical Trials, Prefilled Syringe