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LCMS-9030Liquid Chromatograph Mass Spectrometer JUNE 2019 Volume 31 Number 6 BRAT LE IN E G C A N Y N R IVERSA Bringing Drug Delivery Home FOR PERSONAL, NON-COMMERCIALto Patients USE FORMULATION PEER-REVIEW ANALYTICS Solubility and Bioavailability Managing Raw Data Glycosylation for Biopharma Quadrupole Time-of-Flight LCMS-9030Liquid Chromatograph Mass Spectrometer FOR PERSONAL, NON-COMMERCIAL USE Effortless performance The LCMS-9030 quadrupole time-of-flight (Q-TOF) mass Effortless performance spectrometer integrates the world’s fastest and most with less recalibration and easy switching between sensitive quadrupole technology with TOF architecture. ionization units It delivers high resolution accurate-mass detection with incredibly fast data acquisition for routine applications. Small footprint due to a simple and compact floor-standing design Greater accuracy and higher sensitivity based on patented Ultra-Fast technologies Identify and quantify more compounds with greater confidence in food applications, forensics, drug identification, proteomics and metabolomics www.shimadzu.eu/effortless-performance June 2019 Pharmaceutical Technology Europe is the authoritative Advancing Development & Manufacturing source of peer-reviewed research and expert analyses for scientists, engineers, and managers engaged in process PharmTech.com development, manufacturing, formulation and drug delivery, API synthesis, analytical technology and testing, packaging, IT, outsourcing, and regulatory compliance Cover: daniilantiq2010/ in the pharmaceutical and biotechnology industries. Sylfida - stock.adobe.com Art direction: Dan Ward 13 26 9 38 PharmTech.com GOOD LABORATORY PRACTICES Features 31 Good Laboratory Practices: Getting on the Same Page Quality and compliance depend on the right approaches COVER STORY to training, standard operating procedures, and validation. 9 Bringing Drug Delivery Home to Patients More tools are available to help ensure success. Combination products aim for user-friendly subcutaneous drug delivery. ANALYTICS 33 Leveraging Computational Models API SYNTHESIS AND MANUFACTURING of Glycosylation for Biopharma QA 13 Enabling Technologies Advance Close collaboration between academic and Poorly Soluble Highly Potent APIs industrial groups is vital to ensuring glycosylation Excipients and new processing techniques models are fit for deployment. can make a real difference in the development of highly potent therapies. SUPPLY CHAIN 38 On the Right Track FORMULATION Proactive approaches that consider long-term supply 16 Looking Beyond the Solubility Horizon chain security compliance are recommended to ensure Exploration of various formulation techniques is vital companies stay on the right track. to provide effective delivery of poorly soluble drugs. INHALATIONFOR DRUG PERSONAL, MANUFACTURING NON-COMMERCIAL40 Filling the Early Intermediate Security USEGap 26 Considering Connected Inhalation Drug Delivery With increased focus on supply chain security, A connected MDI may encourage compliance companies need to re-emphasize upstream manufacturing. and aid proper technique. Columns and Regulars SCALE UP 28 Batch or Continuous? Ask the 5 Editor’s Comment Right Questions During Scale Up As Easy as ABC? Continuous manufacturing may offer huge 6 EU Regulatory Watch opportunities but will not be right for every facility. Regulating Cannabis-Based Medicines in Europe 42 Ask the Expert Quality Agreements and Out-of-Specification Investigations Peer-Reviewed Join PTE’s community 19 Defining and Managing Raw Manufacturing Data Join the Pharmaceutical Technology Europe group on LinkedIn™* Protecting the integrity of raw data is crucial and start discussing the issues that matter to you with your peers. to regulatory compliance and to proving that Go to PharmTech.com/linkedin manufacturing and quality operations are being run and managed properly. *The linkedIn logo is a registered trademark of LinkedIn Corporation and its affi liates in the United States and/or other countries Pharmaceutical Technology Europe JUNE 2019 3 EDITORIAL ADVISORY BOARD PharmTech Group Contributing Editor Reinhard Baumfalk Luigi G. Martini Editorial Director Cynthia A. Challener, PhD Vice-President, R&D Chair of Pharmaceutical Rita Peters Global Correspondent Instrumentation & Control Innovation [email protected] Sean Milmo Sartorius AG King’s College London PharmTech Europe (Europe, [email protected]) Editor Art Director Rafael Beerbohm Thomas Menzel Dan Ward Felicity Thomas Director of Quality Systems Menzel Fluid Solutions AG [email protected] Publisher Boehringer Ingelheim GmbH Jim Miller Senior Editor Michael Tracey Agnes Shanley [email protected] Phil Borman, DSc Founder and Former President, [email protected] Sales Manager Director, Product PharmSource, A Global Data Linda Hewitt Managing Editor Development & Supply Company Tel. +44 (0) 151 353 3520 Medicinal Science & Susan Haigney [email protected] Colin Minchom [email protected] Technology Senior Sales Executive Senior Director Manufacturing Editor Stephen Cleland Pharma R&D Jennifer Markarian Tel. +44 (0) 151 353 3647 GlaxoSmithKline Pharmaceutical Sciences [email protected] [email protected] Evonne Brennan Shire Pharmaceuticals Science Editor Sales Operations Executive European Technical Product Clifford S. Mintz Feliza Mirasol Barbara Williams Manager, Pharmaceutical President and Founder [email protected] [email protected] Division, IMCD Ireland BioInsights Associate Editor C.A.S.T. Data and List Information Amber Lowry Michael Kushner Rory Budihandojo Tim Peterson [email protected] [email protected] Director, Quality and EHS Audit Transdermal Product Boehringer-Ingelheim Development Leader, Drug Published by Delivery Systems Division, 3M MultiMedia Healthcare LLC Christopher Burgess Hinderton Point Managing Director John Pritchard Lloyd Drive Cheshire Oaks Burgess Analytical Consultancy Consultant Cheshire CH65 9HQ, United Kingdom Ryan F. Donnelly Thomas Rades Tel. +44 151 353 3500 Fax +44 151 353 3601 Professor Professor, Research Chair Queens University Belfast in Formulation Design and President, MultiMedia Healthcare LLC: Tim Freeman Drug Delivery, University of Thomas W. Ehardt Managing Director Copenhagen VP & Managing Director, Freeman Technology Rodolfo Romañach MultiMedia Healthcare LLC: Dave Esola Filipe Gaspar Professor of Chemistry Vice-President, R&D University of Puerto Rico, Hovione Puerto Rico Sharon Grimster Siegfried Schmitt PTE’s ReNeuron Vice-President Technical Join community PAREXEL Join the Pharmaceutical Technology Europe group on LinkedIn™* Anne Marie Healy Stane Srcic andFOR start discussing PERSONAL, the issues that matter to you with your peers.NON-COMMERCIALProfessor in Pharmaceutics and USE Pharmaceutical Technology Professor Go to PharmTech.com/linkedin Trinity College Dublin, Ireland University of Ljubljana, Slovenia Griet Van Vaerenbergh *The linkedIn logo is a registered trademark of LinkedIn Corporation Deirdre Hurley and its affi liates in the United States and/or other countries Senior Director, Plant GEA Process Engineering Helsinn Birex Benoît Verjans Pharmaceuticals Ltd. 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No part of the publication may be reproduced in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written permission of the copyright owner except in accordance Above is a partial list of the Pharmaceutical Technology brand editorial advisory with the provisions of the Copyright Designs & Patents Act (UK) 1988 or under the terms of the license issued by the Copyright License Agency’s 90 Tottenham Court Road, Lindon W1P 0LP, UK. members. The full board, which includes advisory members of Pharmaceutical Technology North America, can be found online at www.PharmTech.com/pharmtech- Applications for the copyright owner’s permission to reproduce any part of this publication outside of the Copyright Designs & Patents Act (UK) 1988 editorial-advisory-board. Pharmaceutical Technology publishes contributed technical provisions, should be forwarded
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