OINDP cGMP Release & Stability Testing
Nanopharm offers the cGMP analytical testing services required for the release of clinical and commercial Orally Inhaled and Nasal Drug Products (OINDPs). Our analytical method development scientists leverage deep expertise in inhaled drug delivery and specialized laboratory equipment to create dependable, regulatory-compliant testing methods.
Whether for product release or stability programs, Nanopharm efficiently develops and validates cGMP analytical methods tailored to your nasal or inhaled drug product. Once your product is approved and marketed, our analytical laboratories continue to provide timely cGMP product release and accelerated or long-term stability testing.
Where appropriate, we can also transfer the analytical methods to our sister site, Aptar Boonton, who also perform cGMP manufacturing of OINDP for early clinical trials, or externally to your chosen CRO/CDMO if preferred.
Integrated OINDP Stability Testing
Stability tests are demanded by regulators and are essential for understanding product performance over time; stability studies are core to Good Manufacturing Practice.
We develop stability protocols that satisfy FDA and EMA requirements, enabling clinical trials to move forward and providing the data needed to ensure long-term product integrity. We are passionate about the precision of our analytical methods—because we know how critical it is to predict long-term stability from short-term data. We also have stability chambers on site, giving us flexibility to store samples on site or at trusted and specialized third party suppliers, depending on the scale and scope of the stability study.
After each pull, we provide updated stability tables that support continued dosing in clinical trials and help justify commercial product shelf life in alignment with your internal models and regulatory expectations.
These capabilities are complemented by our sister site, Aptar Boonton, who also have on site chambers and perform release and stability testing for programmes in which they are performing the cGMP manufacture, fill and finish of the drug products for early clinical studies.
Nanopharm’s cGMP release testing is exclusively focused on inhaled and intranasal drug products utilizing an array of specialized and conventional analytical techniques in our cGMP qualified laboratory.
Our cGMP analytical laboratory offers in house stability storage in a range of ICH conditions. Nanopharm’s cGMP laboratory supports stability study requirements for short or long term, accelerated or in use studies, to help set the shelf life specifications and ensure your product remains stable.
Full-Service Analytical Support
Our cGMP analytical laboratory services include:
- cGMP release testing for clinical and commercial batches
- Accelerated and long-term stability studies
- Analytical method development and validation
- Data packages suitable for CMC submissions, DPCs, and IVBE studies
- Ongoing support for regulatory filings and product lifecycle management
Our in-house laboratories ensure your OINDP formulations remain stable over time, supporting both clinical progress and commercial readiness with confidence and precision.
cGMP Release Testing for OINDPs
Nanopharm’s analytical services provide complete cGMP release testing for a wide range of inhaled and intranasal drug products. With a full array of conventional analytical equipment, complimented with extensive specialized aerosol and spray testing capabilities, Nanopharm can provide efficient release testing services for all OINDPs. Our cGMP in-house analytical testing options include emitted droplet and particle size distribution, aerodynamic particle size distribution, spray pattern, plume geometry, delivered dose uniformity/output rate, single actuation content, and dissolution tests to name a few. We also offer proprietary and unique nasal and inhaled drug testing techniques to fully characterize OINDPs for today’s regulatory requirements.
All of these capabilities are focused exclusively on providing industry leading cGMP analytical release testing services that are suitable for inclusion in CMC, DPC, and IVBE studies for regulatory submissions. We provide documentation in filing ready formats, including electronic common document (eCTD) formats. Nanopharm makes it easier for our customers, with timely and trusted results they can rely on. These same cGMP analytical testing services are offered to support the efficient release of clinical trial materials (CTMs), so your clinical batches can get into the clinic on time with their safety assured.
cGMP Analytical Stability Testing
Nanopharm’s cGMP analytical testing services are also designed to support your ICH stability testing needs. The same comprehensive cGMP analytical testing services are available to perform product stability testing for in-use, accelerated or long-term stability programs. This ensures that customer intranasal and inhaled drug products, whether they are clinical or marketed products, can receive the same reliable and efficient analytical testing services at all stages of their shelf life. Our on-site storage chambers cover a range of ICH conditions and are fully qualified. They meet cGMP standards and all samples are tested to the highest quality standards by analysts that specialize in testing orally inhaled and nasal drug product testing only. Keep your cGMP stability program on track with Nanopharm’s cGMP stability testing capabilities.
Nanopharm cGMP Analytical Release and Stability Testing Solutions
Nanopharm’s specialized cGMP OINDP analytical testing services can provide the data and documentation needed to support a range of filing types to current quality standards. Our fully qualified cGMP analytical laboratories and analysts exclusively test inhaled and nasal drug products. That makes them uniquely qualified to bring their decades of focused experience to cGMP release and stability testing requirements of OINDPs.
