Dr. Tino Otte

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

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

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

Day 1: Thursday, 22 October 2020

CASE STUDY: E&L Studies tailored for Transdermal Delivery Systems

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.

Day 1: Thursday, 05 August 2021

CASE STUDY: Translating Inhaled and Nasal Technologies for the Delivery of Biologics.

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.

• Overview of currently available technologies and successfully marketed products.
• Review of the development challenges that might be encountered — and the solutions that are available — when formulating these delivery routes.
• A focus on analytical approaches for impurity identification and quantification.
• Key considerations when rapidly repurposing existing products for inhaled delivery.

Day 1: Thursday, 09 March 2023

CASE STUDY: Analytical approaches to cover potentially harmful Impurities in drug formulations

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:

• Sources and kind of potential impurities
• General screening strategies to cover the risks
• Case studies about characterization and quantification of impurities
• Importance of structure elucidation
• Special considerations for substances of cohort of concern not suitable for TTC approach

Day 1: Wednesday, 11 October 2023

CASE STUDY: To Be Announced