Dr. Tino Otte, Intertek (Schweiz) AG - Qepler Summits And Conferences

Dr. Tino Otte

Senior Scientific Consultant
Intertek (Schweiz) AG
Basel-Landschaft, Switzerland
Intertek (Schweiz) AG

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.

Related Sessions:

2nd Annual Pre-Filled
Syringes Summit 2019

Enhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.
  • 04 Jun 2019
  • Barcelona, ES
  • Pharma
Day 2: Wednesday, 05 June 2019
BLOCK: COMPONENT SELECTION AND RISK MITIGATION STRATEGIES.
CASE STUDY: Silicone quantification in injectable drugs – New approaches for 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:

  • Good reasons for monitoring of Silicone content
  • The traditional way – drawbacks and limitations
  • Advantages of new q-NMR method in general
  • q-NMR - Validation and Routine QC made simple
  • Case studies
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Extractables & Leachables
Summit 2019

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 15 Oct 2019
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 15 October 2019
CASE STUDY: Challenges and pitfalls during E&L studies and how to handle them.

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:

  • Screening of containers and process equipment for extractables
  • Screening of the formulation stored under accelerated conditions for potential leachables
  • Tox-assessment and definition of the target leachables and their specification
  • Leachables method validation
  • GMP monitoring of leachables during a stability study in real samples

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:

  • Illustration of a suitable study design covering production process, filling line and final container closure system
  • Extractables of multi-material-equipment and how to clarify their source
  • Temporary leachables detected during stability study
  • Unknown leachables and how to identify them
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2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
CASE STUDY: Analytical approaches for determination of Leachables and Impurities in Combination Products.

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 procedures

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