OINDP Clinical Trial Materials
(CTM)
Manufacturing Support
Nanopharm Clinical Trial Material (CTM) Manufacturing Support
At Nanopharm, we understand the complexities of manufacturing clinical trial materials (CTMs) for Orally Inhaled and Nasal Drug Products (OINDPs). With the acquisition of new fill and finish services now available at our Aptar Boonton sister site we now offer an even more robust solution for your clinical trial manufacturing needs.
Aptar Boonton combines decades of CMC experience with a laser focus on Orally Inhaled and Nasal Drug Products (OINDP) to transform your project into a clinic-ready proposition.
Using a stage-appropriate methodology within the Module 3 framework, our experts work collaboratively with you to manage risk, mitigate delay and reduce cost while ensuring your OINDP product’s quality, safety, and efficacy.
End-to-End Support for Clinical Trial Manufacturing
Few Contract Development and Manufacturing Organizations (CDMOs) offer the specialized, niche services required to manufacture small-scale cGMP OINDPs for clinical trials. Finding the right partner with both the technical capabilities and available capacity can be a significant challenge.
Nanopharm simplifies this process by incorporating the expertise of Aptar Boonton, to meet your early-phase clinical supply needs. We now can manage the technical transfers within the Aptar Pharma network, ensuring a smooth and rapid process that reduces the number of third parties you need to coordinate. This means:
- No long waits for production slots
- No need to over-manufacture due to mismatched capacity
- No unnecessary delays to your clinical program
- Direct access to the device experts when using Aptar Pharma drug delivery systems
From early phase clinical trials, we are here to provide the manufacturing support appropriate to your API’s stage of development. Together will help you bridge your idea from the laboratory to the clinic, and then onto your commercial manufacturing site. We provide the crucial scientific insights needed to get your product ready for the clinic and ready for commercial manufacturing.
We bring a long-held focus on quality alongside up-to-the-minute insight into the latest regulatory standards. And our service portfolio ensures you’re supported from process development and validation to scale-up and technology transfer.
Expanded Capabilities Through Aptar Boonton
The team specializes in managing clinical supplies for drug development, offering services such as sourcing clinical trial materials (CTM), small-batch manufacturing, stability testing, and finished product release testing, all in cGMP-compliant facilities:
- FDA inspected, 32,000 sq ft manufacturing facility in NJ, USAGMP fill and finish services for Phase 1 and 2 trials
- High-potency API handling
- Controlled drugs handling
- Advanced cleanroom and containment infrastructure
- Controlled temperature and humidity cleanrooms
The cGMP FDA-inspected facility in Boonton, New Jersey, is fully aligned with Aptar Pharma’s drug delivery solutions and accelerates the development of innovative therapies—initially focused on OINDPs, with future potential in dermal, ophthalmic, injectable, and secondary packaging formats.
Device and Formulation Expertise
Aptar Boonton is equipped to manufacture CTMs across a wide range of Aptar Pharma’s drug delivery systems, including:
- Nasal sprays
- Nasal powders
- Dry powder inhalers (DPIs)
- Nebulizers
Whether your formulation is a simple solution or a complex engineered powder, Nanopharm ensures that your clinical materials are manufactured to the highest standards of quality, safety, and compliance.
Scientific and Quality Oversight
Nanopharm provides scientific and regulatory support throughout the manufacturing process. From formulation development to technical transfer and batch release, our team ensures a worry-free transition and timely delivery of your CTMs.
With our expanded network and integrated capabilities, we help you move faster through early development—without compromising on quality or control.
Nanopharm OINDP Clinical Trial Material (CTM) Manufacturing Support
Let Nanopharm develop your next clinic-ready nasal or inhaled drug product, and then support the efficient manufacturing of the clinical materials needed to get into the clinic sooner. This integrated service allows you to focus on what you do best, and that’s bringing new OINDPs to market.
