Editor in Chief Carla Scesa - Editorial Director Silvana Maini - Managing editor Carlo Buonamico - Associate Editor Gayle De Maria - Production Manager & Editorial Coordinator Elisa Novaresi - PHARMA HORIZON vol 1(3) - 2017 focus on Pharma Packaging and Excipients TABLE OF CONTENTS REGULAR COLUMNS: 2 EDITORIAL 6 LATEST NEWS 10 INTELLECTUAL PROPERTY 14 COMPLIANCE 18 MARKET ACCESS 34 MERGERS & ACQUISITIONS 63 PRODUCTS & SERVICES P HARMA H ORIZON PHARMACEUTICALMANUFACTURINGVALUECHAIN Focus on Not just a telling story... Don’tmiss theCoverStory inside LuigiTrussardo CEO ofOlonRicercaBioscience Poste Italiane Spa - Sped. inAbb.Postale -D.L.353/2003 (conv. In L. 27/02/2004n.46) -art.1comma 1 -DCBMilano• PHARMAHORIZON -vol 1(3) 2017 - focuson Pharma Packagingand Excipients •Publishedby Tekno Scienze Srl HTA:howcanwe improve it? NEWS Latest PACKAGING EXCIPIENTS NathalieMoll A word with... Olon COVER STORY Production Assistants & It Department Luis Alburqueque Diaz - Matteo Cattane - Marketing & Sales Giulio Fezzardini - Silvia Baldina - Simona Rivarollo - Steven Max - Marketing & Events Paola Passadore - Administrative &Account Alba Aprea - TEKNO SCIENZE SRL Viale Brianza, 22 - 20127 Milano (Italy) Tel +39-02-26809375 /28381260 Fax +39-02-2847226 e-mail: PRINTING Arti Grafiche Colombo (Muggiò - MB, Italia). 4 All rights reserved toTekno Scienze Srl. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means: electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisherTekno Scienze Srl. SPONSORED ARTICLES 40 COMPANY PROFILE JRS PHARMA - Specific Excipient Requirements in Continuous Tablet Manufacturing 24 An outcome based approach to drug delivery 26 Serialization programs: overlooked business risks and pitfalls 30 User’s safety and patient adherence: progress and perspectives PACKAGING Focus on 37 The specialty excipients market for oral- solid-dosage-form pharmaceuticals: a growth close to 6% during 2016-2021 44 GMP for pharmaceutical excipients in Europe: Including current perspectives and supplier certification 48 Excipients and their effects on the quality of small molecules 52 Viscosity of monoclonal antibody formulations: excipients to reduce it and analytical methods for its measurement 56 Utilization of coprocessed excipients to expedite product development EXCIPIENTS Focus on Carl-Åke Carlsson - Xellia Pharmaceuticals 8 Philipp Haas - DEVA 12 Oriol Prat - Grifols International 16 Nathalie Moll - EFPIA 22 A word with... 59 DOSAGE FORM Orally disintegrating dosage forms: discussing market specific formulation strategies