Now more than ever, the need to present case studies, share testing results and discuss feedback is of vital importance in understanding and working towards future achievements and innovations within the pharmaceutical industry.
At Extractables & Leachables USA 2016 in Bethesda this May, some of the biggest names in the extractables and leachables field will share their case studies, recent testing results and feedback, as well as examining progress on case studies presented at previous editions of the E&L conferences.
Sharing case studies and testing results plays a significant role in the development and progress of extractables and leachables testing, with the feedback able to be applied to future studies and risk assessments. Click here to see a case study presented at E&L Europe 2015 by Merck Serono >>
Piet Christiaens of Toxikon Europe: How understanding the Chemistry and Reactivity of Halogenated Rubber Oligomers can help in Identifying Unknowns in Extraction Profiles of Exhaustive Controlled Extraction Studies
It is commonly known that halogenated rubber oligomers are a group of compounds which are often observed, both as extractables, in controlled extraction studies, as well as – in certain cases - as leachables in some drug products.
Although there is an ongoing debate upon the toxicity of this group of compounds, it is a fact that these compounds are alkylating agents with a high reactivity for certain functional groups. These interactions have been widely observed – forming adducts with components of the drug products (API, Peptides, proteins, excipients).
A second observation is that, when performing a controlled extraction study on rubbers with more aggressive solvents (like IPA, Hexane), a potentially longer list of UNKNOWNS is generated, both in GC/MS and LC/MS, of which the origin is not always very clear.
The question now arises: knowing and understanding the high reactivity of these halogenated rubber oligomers, would it be possible that a group of these reported unknowns could be linked to reaction products of the oligomers with other rubber ingredients, such as curing agents, activators, accelerators…
Toxikon is currently running an R&D programme to systematically allow the halo rubber oligomers – which are available at Toxikon – react with other rubber ingredients under the typical conditions of rubber curing. Initial results of this R&D programme will be shared with the audience.
Roger Pearson of Aspen Research: Extractables Assessment, Leachables Simulation and Lerachables Study of an Infusion Delivery Device
Infusion devices for intended use with multiple drugs carried by multiple delivery solvents pose an interesting analytical problem as regards potential leachable compounds and elements. In many cases a device is dedicated to a single drug and delivery solvent. In those cases it is usually possible to find the set of analytical conditions that allow the drug product to be interrogated for leachables after the appropriate extractables assessments have been performed. This presentation will describe the steps taken to perform the initial extractables assessments and the following work that was done using the drug carrier simulants and finally the full drug package in the leachables study.
Jonathan Bones of National Institute for Bioprocessing Research and Training (NIBRT): Characterisation of Extractable and Leachable Impurities in Single Use Bags Used During Biopharmaceutical Production
The development of an analytical platform for the characterisation of extractable and leachable impurities present in single use technologies is presented. Passive extraction of extractables under a variety of different conditions was evaluated. For leachables, an additional sample preparation step was required for matrix removal and sample clean up prior to instrumental analysis. The application of the developed analytical platform to the characterisation of a large number of bags of different brands from different vendors will be presented.
Samuel Kikandi of Sanofi Pasteur: A Complete E&L Qualification Case Study of New Label on Plastic PFS
An E&L qualification case study of new label on plastic PFS. The presentation will encompass of the following studies: 1) Extractable studies of ink, label and adhesive; 2) Simulated In-use leachable study with labeled plastic PFS; 3) Leachable migration study from label into the plastic syringe.
View the full programme >>
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