Experts in functional stability programs for drug delivery and combination products
The rapidly accelerating demand for combination pharmaceutical products continues to fuel innovation and create many exciting opportunities, which bring promising new alternatives to advance patient care and outcomes. However, the convergence of drugs/biologics and devices brings a host of new challenges in product development, testing and patient compliance.
Safe self-administration of drugs via autoinjectors / needle based injection systems has taken burden off the healthcare system with convenient administration helping to reduce waste and dosage errors. However, these devices have created new challenges for pharmaceutical drug manufacturers. It is imperative that drug manufacturers planning to utilize a prefilled syringe or autoinjector platform execute a rigorous mechanical stability program to understand the device performance throughout the product lifecycle. If these stability programs are not executed properly, companies are exposing themselves to high risk in the form of patient complaints and injuries. Companies must respond within 60 days to the FDA for any field complaint and these events can cost companies a lot of time and money. Similar to the shortage of sterile fill / finish capacity experienced by the pharmaceutical industry, there is also a high need for controlled GMP storage / chambering conditions.
To address these industry challenges, DDL has opened a state-of-the-art GMP laboratory near our Eden Prairie, MN headquarters. This new FDA registered 10,615 square foot lab is our center of excellence dedicated to the pharmaceutical industry.
Our GMP lab specializes in design verification, stability programs, method validation and lot release in the following areas:
- Pre-filled Syringes
- Needle-based Injection Systems
- Needle Testing
- Shelf-life/Stability Studies
- ISO 11607 packaging validation
- Particulate analysis
- Lot release
DDL has over 35 years of first-hand experience navigating these complex testing standards and industry regulations for medical devices and combination products. We conduct performance and mechanical testing per the recommendations set out by the FDA in their guidance document and the related industry standards, including long term stability studies to validate performance throughout the target shelf-life. Our expertise and reputation for extraordinary, responsive service keep projects on track through tight development timelines.
Contact us for more information or to talk to an engineer.
Lab Testing Quality & Accreditations
Learn more about our commitment to quality.
DDL is an
ISO 17025
Accredited
& GMP Laboratory
Designing a Pre-Filled Syringe Test Plan Webinar
Companies developing pre-filled syringe combination products are often put in a bind when it comes to timing and execution of design verification studies. All too often, product rolls off the manufacturing line and then is rush shipped to testing sites for expedited service. Working with a test lab that is seasoned, responsive and flexible can certainly make these hectic situations less severe for the entire program. This information-rich webinar highlights DDL’s best practices for ensuring a test program is established on firm ground and executed flawlessly.
Why DDL?
What we do at DDL matters to the lives of people. This is what drives us to become the most responsive and intelligently resourceful testing experts.
“As always it was a pleasure to work with (DDL). I especially appreciate your steady stream of communication as well as your willingness to do whatever is necessary to expedite our tests wherever possible. I can almost guarantee that you will be doing more testing for us in the near future and probably many more times to follow.”
