OINDP Analytical Services
Nanopharm’s Integrated OINDP Analytical Services
Nanopharm are experts in analytical services for OINDPs including intranasal and inhaled drug products no matter their stage of development. From release to stability testing for established marketed products to analytical method development and validation for early phase OINDP innovator or generic programs, Nanopharm is your analour analytical specialist. Our fully equipped cGMP analytical laboratories are designed to support the rapid development of new OINDP products along with submission-ready data and documentation for regulatory authorities.
Nanopharm’s analytical services are a critical part of the early phase development (R&D) of intranasal and inhaled drug products using specialized scientific knowledge and technology.
Our cGMP analytical laboratory is focused on release and stability testing for intranasal and inhaled drug products.
Nanopharm knows and performs analytical services required by the in-vitro bioequivalence (IVBE) guidance for different regulatory bodies including the U.S. FDA and EMA.
Nanopharm applies specialized testing and modeling to meet the current alternative pathway to in-vitro in-silico based generic product bioequivalence.
Nanopharm uses a data-driven approach, built upon a strong analytical R&D platform to accelerate and derisk intranasal and inhaled drug product development. From the earliest phases of research and development (R&D), Nanopharm applies innovative and unique analytical approaches alongside compendial methods to build a complete picture of the product’s critical quality attributes. Our R&D analytical capabilities allow our scientists to fully characterize APIs, optimize the formulation and evaluate technologies for drug delivery, as only an OINDP specialist organization can. From spray characterization to analytical method development and validation, Nanopharm is ideally suited to provide the specialized analytical R&D services that customers need at all stages of inhaled and intranasal drug product development.
Your inhaled or intranasal drug product requires reliable and robust analytical testing to release the product to market. They must be tested to cGMP standards in order to meet release requirements and complete long-term stability programs. Nanopharm provides the comprehensive and specialized analytical testing services needed by today’s OINDP products. Whether it’s for clinical trial materials (CTMs) or commercially approved marketed nasal or inhaled drug products, Nanopharm’s cGMP laboratory can develop, validate and test OINDP products to current standards with timely release testing results. Data generated by Nanopharm’s specialized cGMP analytical laboratories is suitable for inclusion in Chemistry Manufacturing Controls (CMC) submissions, drug product characterization (DPC) filings or in-vitro bioequivalence (IVBE) studies for inclusion. With both accelerated and long-term stability study capabilities, Nanopharm’s specialized analytical capabilities can help ensure your OINDP product remains stable throughout its shelf life.
In-vitro Bioequivalence (IVBE) study requirements for orally inhaled and nasal drug products (OINDPs) have been clearly defined by major regulatory bodies such as the EMA and U.S. FDA. For generic inhaled products, they must be performed in addition to human clinical studies in order to demonstrate bioequivalence to reference products in order to gain approval. For nasal products, there is now an in-vitro only pathway to bioequivalence and Nanopharm can perform the full suite of necessary tests. Innovator and repurposed OINDPs also require these same specialized analytical tests to be performed to generate data for submission in CMC sections of their applicable regulatory filings. With a full array of modern and specialized analytical instruments operated by a team of experienced respiratory scientists, Nanopharm can deliver the analytical data and documentation needed to satisfy today’s IVBE and CMC testing requirements. Specialized analytical tests required for nasal and inhaled products can include delivered dose uniformity (DDU) or single action content (SAC), droplet size distribution (DSD) by laser diffraction, drug in small particles / droplets or aerodynamic particle size distribution (APSD) by cascade impactor, and spray pattern and plume geometry testing. Nanopharm can perform other characterization studies including resting time and orientation effects, temperature cycling, in-vitro dose proportionality, varying flow rates, effect of storage on particle size, and preservative effectiveness testing to satisfy the strict requirements for inhaled drug products.
Nanopharm’s scientists are dedicated to the development and testing of nasal and inhaled drug products. Our development capabilities include innovative alternative in-vitro in-silico driven pathways to bioequivalence. Using specialized techniques such as Morphologically-Directed Raman Spectroscopy (MDRS) and dissolution testing, Nanopharm’s analytical services can advance the development of generic OINDPs in compliance with current regulatory guidance. Nanopharm has been working closely with the U.S. FDA and attending their workshops in efforts to add our innovative in-vitro bioequivalence testing to the regulatory body’s guidance and requirements for inhaled and nasal drug products.
Nanopharm cGMP Analytical Services Advance Nasal and Inhaled Drug Products
Nanopharm’s specialized cGMP OINDP analytical services can develop and validate robust methods, as well as 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 test only inhaled and nasal drug products, applying their OINDP expertise to every customer project. That makes Nanopharm uniquely qualified to perform the development, validation, testing and release of a range of OINDPs.
