Tino Otte, Senior Scientific Consultant at Intertek, is an expert for analysis of impurities and contaminations in pharmaceutical products.
He holds a degree in polymer-chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010.
He joined Intertek (Schweiz AG) in 2016. Prior to joining Intertek, he worked with different research, development and manufacturing companies where he served in several functions in product management and development of analytical services.
He has more than 7 years of experience in GMP regulated environment within multiple areas of product analysis including method development, validation and QC.
Silicone quantification by q-NMR is presented as a more sensitive and faster method compared to traditional techniques. Advantages such as the simplified sample preparation, reduced sample quantity and less matrix influence will be highlighted. The application range of the method and the general procedure are explained in detail and case studies are shown. Content:
For patient safety reasons a precise knowledge about potential drug impurities is essential. With increasing complexity of container closure systems and single use process equipment the risk of leachables being introduced as real drug impurities increases significantly. Authorities are extensively focusing on determination of leachables present in the real drug matrix which increases the analytical effort and complicates data interpretation.
According to general guidelines the E&L studies are commonly divided into different parts:
During this presentation we will focus on the problems which may occur when extractables or leachables above the analytical evaluation threshold are detected during the different steps. Several case studies will be presented. Content:
Combination products often contain different types of polymeric construction materials and therefore they are often associated with an increased risk of the presence of Leachables. In many cases large contact surfaces of the different materials are exposed to relatively small volumes of drug formulations which further increases the risk of unwanted interactions.
Moreover, special combination products such as drug eluting stents and other devices with a functional coating are used more frequently. For such products a precise and robust determination of very small levels of coating-related impurities is essential.
In this presentation effective strategies for performing Extractables and Leachables investigations on combination products will be shown including case studies which illustrate the application of such strategies in the daily practice.
In addition, a highly sensitive determination method for volatile and semi volatile impurities will be introduced, which is directly applied to coated devices in order to determine process related impurities in a quantitative way under GMP without the need of complicated, time intensive and often error-prone sample preparation proceduresView Details
Transdermal patches and related pharmaceutical products have a huge potential for leaching substances from different assembly parts and secondary packaging due to the variety of materials involved. Extractables and leachables (E&L) are unwanted, potentially harmful, substances which could be applied to the patient during medication. The impact of E&L is often underestimated which leads to increased attention of the authorities to this specific topic.
With a focus on complex drug-delivery-products, such as transdermal patches, we look at how E&L studies can be effectively applied to understand how the formulation or sweat of the patient interact with the different materials to ensure a safe medication. Illustrative examples from E&L studies are provided with special attention to an efficient study design which will fulfil the regulatory requirements but not unnecessarily exceed the worst case conditions.View Details
Inhaled and nasal delivery platforms have specific applications outside of their traditional uses for asthma/chronic obstructive pulmonary disease (COPD) and seasonal rhinitis/sinusitis: They can offer real advantages for the delivery of therapeutic biologics.
Despite the guidance about assessment of genotoxic impurities in ICH M7 there are still difficulties when it comes to analytical screening and characterization of such compounds.
Frequently, the interference of drug matrix components makes impurity analysis quite difficult. Moreover, in case of presence of substances of the cohort of concern the analytical limits are often extremely low and could hardly be reached with current methods or instruments.
In this presentation the following topics will be covered: