Day 1 :
Keynote Forum
Edislav Leksic
Almac Group, UK
Keynote: Understanding the importance of diversity of particle size methods based on laser diffraction
Time : 09:30-10:15
Biography:
Edislav Lekšić is the Team Leader of Physical Sciences at Almac Sciences. He has worked in the pharmaceutical industry for the past 12 years, with expertise in solid state chemistry related to API selection, crystal surface property, scale-up and production troubleshooting. He has been involved in preformulation work and development of systems such as solid dispersions and cocrystals. He has worked closely with patent law authorities contributing to aspects of IP. He has a strong GMP background and experience in XRPD and PSD method validation and transfers. He received a PhD in supramolecular chemistry from the University of Zagreb.
Abstract:
It is known that particle size can play a significant role on drug substance and product performance (e.g. solubility) and manufacturability (e.g. flowability). Due to low water solubility, in most cases particle-size distribution (PSD) methods intend to measure primary particles in the bulk as there is direct correlation of particle size and kinetics of solubility. For the release methods, the decision on what aspects of particles a given PSD method should measure is ideally based on the Quality Target Product Profile (QTPP) of the drug product. The measurement of agglomerates in the bulk is crucial for formulations where agglomerates remain intact due to their hardness. PSD methods are useful for processes monitoring such as micronization or drying, where secondary agglomeration might happen for controlling process modifications (process improvement) including scale-up processes. PSD methods are sometimes selected as tests involved in stability protocols with reference to the results observed for batches used in bioavailability or clinical studies for drug self-life determination. For more challenging active pharmaceutical ingredients (APIs) regarding bulk properties, a batch-to-batch comparison method might be suitable to distinguish between batches. The different types of PSD methods mentioned above can be applied during different project stages (R&D and GMP) and for different purposes. Such diversity of PSD methods, as well as the fact that there is no general PSD method listed in any pharmacopoeia, might confuse programme leaders and manufacturers. This lecture gives overview on basic principles of PSD methods based on laser diffraction and stress the challenges during method development and method transfers.
Keynote Forum
Lisa Elviri
University of Parma, Italy
Keynote: Liquid chromatography-electrospray-mass spectrometry lipid profile of human fibroblast cells exposed to 3D printed chitosan scaffolds developed for soft tissue regeneration
Time : 10:15-11:00
Biography:
Lisa Elviri has completed her PhD at Parma University, IT in 2001. She is an Associate Professor of Analytical Chemistry at the Food and Drug Department of the University of Parma. She works mainly on sample preparation, liquid chromatography, mass spectrometry based techniques, 3D printing and biomaterial for regenerative medicine. She has over 90 publications that have been cited over 2300 times, and her publication H-index is 27. She is the Founder and President of M3datek Srl an innovative start-up dedicated to the 3D printing of biomaterial-based medical devices for regenerative medicine.
Abstract:
Tissue engineering is a promising field of regenerative medicine that relies on the developing synthetic or naturally-derived biological substitutes (scaffolds) capable to help injured tissues to heal properly. Polymeric materials are often selected as promising candidates for scaffolding thanks to their high surface-to-volume ratio, their structural similarity to the matrix and in function of their final biomedical purpose. Furthermore, 3D biomaterial manufacturing strategies show an extraordinary driving force for the development of innovative therapies in the tissue engineering field, based on the interaction of three main elements: a supporting material, growth factors, and cells. Interaction mechanisms are the entanglement of macromolecules, lipids and interdigitation of the ECM with the physical biomaterial 3D structure, for example, pores. Here, the lipid profile of human fibroblast cells growth on 3D printed chitosan (CH) scaffolds was explored in terms of qualitative and quantitative profile, as a function of the time. Lipids play multiple roles within cells, such as those in energy storage, autocrine and paracrine signaling, and autophagy. Scaffolds were made by a home-made 3D cryo-printing process from formulations at the 6% w/w of chitosan, gelled in 1.5 M potassium hydroxide. Human fibroblast were grown on the 3D scaffolds and the lipid extraction was carried out by evaluating the performance of three different exctration protocols: butanol/methnol (BUME), metyl-tert-buthyl ether (MTBE) and hexane/isopropanol (HI). Three different classes of lipids were analyzed: fatty acyls, phospholipids and sterol lipids by liquid chromatography-triple quadrupole mass spectrometry. The results will be presented and discussed as a function of the extraction protocol, the scaffold properties and the growing time.