Weichun Yang | Senior Manager, Baxter

This session will provide an update on the development of ICH Q3E and challenges ahead. The decision of developing a new chapter ICH Q3E Guideline Impurity is made and what the new chapter will look like, what and when it might be delivered.
Andrew Teasdale | Senior Principal Scientist – Impurity Management and External Advocacy, AstraZeneca

This session will discuss and compare different requirements globally and the possibility of one biocompatibility evaluation report meeting multinational regulatory requirements.

The compatibility of parenteral drug products and their drug delivery systems has received increasing attention from regulatory agencies and pharmaceutical companies are required to perform compatibility studies while submitting drug applications. However, in most circumstances, for drug products manufacturers that do not produce drug delivery systems (e.g. base IV or infusion devices), it is difficult to control which brand/material of drug delivery systems the hospitals use. Therefore, it is important to properly design the compatibility test with limited lab resources. This presentation will illustrate general considerations for the design of E/L studies of drug delivery systems. And from the perspective of a pharmaceutical company, we will discuss whether it is always necessary to carry out extractable profiling experiments by presenting several case studies.
Xiaoxia Ye | Manager, Huadong Medicine

Guangming Wu | Technical Customer Manager, SCHOTT

Drug delivery system is a special device used in treatment of disease. Because the drug delivery system is normally composed of polymer with high level of additives, so it is necessary to design a scientific and reasonable E&L study on drug delivery system and related drug product.
This presentation will give a brief introduction on the challenges of such E&L study:
1: Which type of drug delivery system should to be considered?
2: Which material of drug delivery system should be chosen for E&L study?
3: How to design a scientific E&L study on drug delivery system and related drug product.
 
Xiaojun Yang | Technical Director of Biomedical Technology Center, Shanghai WEIPU Chemical Technology Service Co., Ltd.

Transdermal drug delivery systems are relatively complex pharmaceutical products. The formulation contains multiple excipients and in addition a dermal contact adhesive. The performance of the delivery systems depends on the quality of the dermal adhesive and the formulation, which delivers the drug on a pre-determined rate. 
The dermal delivery route is getting more and more popular, since the effect of the delivered drug can be localized, which may reduce or even eliminate the systemic side effects. However, since the formulation has extended contact time, besides the drug is being delivered excipients, degradation products and packaging related components can also be non-intentionally “delivered” with the same route of administration.
The extractable testing of transdermal systems is straightforward, does not requires “out of box” thinking. In contrary the leachables testing requires more complex approaches, as the regulatory expectation is to test the finished products with biologically relevant extraction media. 
The presentation will focus on different test approaches, to present options for leachable testing, how to evaluate the actual leachables and validate analytical methods what are requires non-routine extraction methods and as well detection capability down to ppb level. Few examples also will be provided for mitigating FDA deficiency letters related to transdermal delivery systems. 
The complex formulation combined with the low level testing requirement are very challenging analytical task. Component identification, analytical method development and validation are not as simple as for the components present at a ppm level or above.
 
Gyorgy Vas | Technical Scientific Liaison, Intertek

•   Supplier and end-user collaboration
•   Extractables ecosystem
•   Data review process
•   Extractables protocol update 
•   Community of practice
Haiyan Hong, R&D manager, Saint-Gobain Research Shanghai
Carsten Worsøe | Principal Scientist Extractables and Leachables, Novo Nordisk

Single use systems (SUS) have been widely used in biopharmaceutical industries in recent years. SUS or SUS components have many advantageous application either in clinical or in commercial manufacturing. Accordingly, the general requirements for extractables and leachables (E&L) are enacted by regulation in USA, EU, and China. For the specific regulatory requirements on E&L, China has only issued the guidelines as to the primary packaging systems (i.e. plastics, elastomer and glass) of chemical drug products. Henlius uses SUS in all stages of antibody drug manufacturing processes, and the submitted E&L study, in accordance with BPOG & USP guidance, had been accepted by NMPA and EMA for NDA/MAA application. The presenter will give a brief introduction on the domestic and international regulatory expectations as well as industrial approach on E&L study. Additionally, some case studies will be shared and discussed during process development and post approval changes.
Lei Zhang | Physicochemical Analysis Director, Shanghai Henlius Biotech , Inc.

Determination of extractable and leachable (E&L) from polymeric materials, components and systems used for manufacturing pharmaceutical products and biopharmaceutical substances and products is important. Extractables generated in reasonable worst conditions can be used to evaluate potential leachables, which can adversely alter a key quality of DP and pose a risk for patient safety. Analytical Instruments such as LC/MS, GC/MS and ICP/MS are often used to identify and quantify organic E&L compounds and elemental impurities. In this presentation, we will share our experiences of identifying organic E&L compounds based on executing standardized protocols (BPOG and USP <665>). The increasing availability of extractable datasets aligned to standardized protocols has led to a deeper understanding of extractable profiles in different solvents. The aim of these studies is to drive further industry alignment among suppliers, end users and regulators that improves the evaluation on extractable and leachable compounds and its risk based on the best practice.
Xiaoxiang Li | Manager - Scientific Laboratory Service Validation, Pall (China) Co., Ltd.