Packaging and Label Testing for NDA Application Supportread Details
Modality Solutions’ ASTM/ISTA Testing Solutions deliver the data you need to meet regulatory requirements, avoid delays in the review process, and help bring your therapy to the commercial market successfully.Request a Consultation
When you’re preparing to file with regulators, it’s imperative that you can demonstrate your intended packaging is up to the challenges of the biopharma drug supply chain. For packaging qualification, testing to the ASTM and ISTA standards can yield that data.
Modality Solutions has helped many biopharmaceutical companies complete the packaging qualification work needed for a successful regulatory filing. Our ASTM/ISTA Testing Solutions help drug developers obtain the robust data required to complete the packaging section of their NDA or BLA filings to regulators’ satisfaction—facilitating the review process and increasing the odds of a successful filing.
For pharmaceutical and biopharma companies that need to test how well their drug formulation will stand up to the environmental hazards they will face in transit, Transport Simulation is much more effective than ASTM or ISTA testing. A transport simulation study goes far beyond test standards like ISTA 3A and other ASTM/ISTA tests that don’t simulate all five environmental hazards concurrently and in the worst-case conditions. When it comes to testing drug formulations for physical and chemical stability at the operating edge of your supply chain, a transport simulation study is the optimal way to obtain accurate, reliable results.Discover how our Transport Simulation Solutions can accelerate your therapy’s approval
SUNESIS CASE STUDY:
As Sunesis prepared to file its controlled-room-temperature hematologic cancer therapeutic, it needed to obtain the test data to demonstrate the proposed shipping method’s suitability and the..View the case study now
ABBVIE CASE STUDY
AbbVie was transporting refrigerated and controlled-room-temperature drugs together in mixed-load trailers and wanted assurance that this approach complied with cGMP/cGDP standards and regulatory expectations. Modality Solutions’ cold chai..View the case study now
Modality Solutions is much more than a testing service. We’re a team of Cold Chain EngineeringTM experts with the backgrounds and experience to support your packaging testing needs from start to finish.
Many labs can run an ASTM or ISTA test on your drug packaging. You choose the test you want, they perform it, and you receive a data package when the testing is finished. But there’s no assurance you’ve run the right tests—and no support for completing your regulatory filing documents.
From helping you comply with ISTA Standard 20 for passive thermal shippers, to conducting vibration, low pressure, shock, compression, and other tests, Modality Solutions can run the full spectrum of ASTM and ISTA packaging testing. And when it’s time to test your drug formulation against the environmental hazards it will encounter in transit, our Transport Simulation Solutions can provide assurance that your therapy will maintain its efficacy and safety along the way.
Modality Solutions can perform testing to the following ASTM and ISTA standards, either at our in-house Transport Simulation Lab or via a third-party certified lab. Our testing services always include development of the necessary test protocols and a written report of results.
ASTM Testing that primarily focuses on the D4169 standard and related standards for testing shipping containers and systems, including both parcel-level and pallet-level shipments
ISTA Testing, covering testing for a wide range of packaging types and modes of distribution
First published on April 20, 2015 on Cold Chain IQ – as a contributor,...read Details