Pharmaceutical Technology Europe- February 2022

Pharmaceutical Technology Europe February 2022

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© 2022 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978- 646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to PTpress@mmhgroup.com with "Permissions" in the subject line. MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers name, addresses, phone num- bers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact information available to third parties for marketing purposes, simply email mmhinfo@mmhgroup.com and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. Pharmaceutical Technology does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. Reprints: Contact Mike Tracey, mtracey@mjhlifesciences.com. Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. Permissions: Submit a request to PTpress@mmhgroup.com with "Permissions" in the subject line. To subscribe: mmhinfo@mmhgroup.com EDITORIAL Editorial Director Chris Spivey CSpivey@mjhlifesciences.com PharmTech Europe Editor Felicity Thomas FThomas@mjhlifesciences.com Senior Editor Meg Rivers MRivers@mjhlifesciences.com Managing Editor Susan Haigney SHaigney@mjhlifesciences.com Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Assistant Editor Grant Playter GPlayter@mjhlifesciences.com Creative Director, Publishing Melissa Feinen Senior Art Director Marie Maresco Senior Graphic Designer Maria Xelo Susan J. Schniepp sue.schniepp@mac.com; Eric Langer info@bioplanassociates.com; and Cynthia A. Challener, PhD challener@vtlink.net 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com Address Published by Multimedia UK, LLC Sycamore House, Suite 2 Lloyd Drive Cheshire Oaks Cheshire Ch65 9HQ, United Kingdom Tel. +44 151 705 7601 SALES Publisher Michael Tracey MTracey@mjhlifesciences.com Sales Manager Linda Hewitt Tel. +44 (0) 151 705 7603 LHewitt@mjhlifesciences.com Senior Sales Executive Stephen Cleland Tel. +44 (0) 151 705 7604 SCleland@mjhlifesciences.com Sales Operations Executive Sarah Darcy SDarcy@mjhlifesciences.com Senior Vice President, Industry Sciences Michael Tessalone C.A.S.T. Data and List Information Michael Kushner MKushner@mjhlifesciences.com Permissions PTpress@mmhgroup.com with "Permissions" in Subject Line Audience Development Research Director Christine Shappell cshappell@mjhlifesciences.com MJH LIFE SCIENCES® President & CEO Mike Hennessy Jr Chief Financial Of ficer Neil Glasser, CPA/CFE Chief Operating Of ficer Michael Ball Chief Marketing Of ficer Brett Melillo Executive Vice President, Global Medical Af fairs & Corporate Development Joe Petroziello Senior Vice President, Content Silas Inman Vice President, Human Resources and Administration Shari Lundenberg Vice President, Mergers & Acquisitions Chris Hennessy Executive Creative Director Jeff Brown Bio/Pharma Outsourcing Innovation 2022 OUTSOURCING SERVICES 4 The Next Frontier in Pharmaceutical Outsourcing Stephan Hütter 8 What Outsourcing Partners Wish You Knew Meg Rivers ANALYTICS 12 Establishing Systems Suitability and Validity Criteria for Analytical Methods and Bioassays Thomas A. Little and Daniel S. Harding DEVELOPMENT 18 Method Development in Demand Felicity Thomas 20 Gaining Formulation Expertise through Partnerships Felicity Thomas 23 Balancing Internal Focus Against External Capabilities Chris Spivey MANUFACTURING 28 Preparing for the Future: Expanding Capacity and Facilitating Multi-modalities James Park 30 Spray Drying Finds Growing Use for ASDs Jennifer Markarian QUALITY/REGULATIONS 34 Fostering Orphan Drugs Susan Haigney 36 Ad Index On the cover: Monstar Studio - Stock.adobe.com Art Direction: Maria Xelo

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