OnDrugDelivery Pre filled 6/8/06 22:29 Page 1 PREFILLED ...

1 OnDrugDelivery Pre filled 6/8/06 22:29 Page 1. PREFILLED SYRINGES. THE TREND FOR GROWTH STRENGTHENS. OnDrugDelivery Pre filled 6/8/06 22:29 Page 2. PREFILLED syringes: the trend for growth strengthens . CONTENTS. This edition is one in a series of sponsored themed publications from OnDrugDelivery Ltd. Each issue will focus on a specific topic within the field of drug delivery, and contain up to eight Introductory comment articles contributed by industry experts. Guy Furness 3. Full contact information appears alongside each Trends and requirements on prefillable syringes: article.

2 Contributing companies would be delighted past, present and future developments to hear from interested readers directly. Dr Thomas P Schoenknecht OnDrugDelivery would also be very pleased to (Buender Glas GmbH) 4-8. pass on to authors, or answer as appropriate, any queries you might have in relation to this publication or others in the series. Meticulous attention to detail: the key in PREFILLED syringe production Forthcoming editions cover: nasal drug delivery; Horst Koller, Walter Schiess (Schott AG) 10-12. oral drug delivery; delivering injectables; novel biomaterials for drug delivery; safer injections.

3 Reducing time-to-market: nanotechnology in drug delivery; transdermal successful drug manufacturing delivery; and pulmonary delivery, among other Dr Juergen Koch topics. To find out more about receiving or (Vetter Pharma-Fertigung GmbH & Co. KG) 14-17. participating with any of these issues, please contact OnDrugDelivery Ltd. Packaging in PREFILLED syringe systems: Contact: selection and evaluation Guy Furness, Publisher Frances L DeGrazio T: +44 1273 831 370 (West Pharmaceutical Services, Inc.) 20-22. E: Current market and key trends of devices used in self-injection Jo l Cotten (BD Medical - Pharmaceutical Systems) 25.

4 PREFILLED syringes: the trend for growth Company Profile: strengthens The Medical House plc 29. Published by OnDrugDelivery Ltd, Cedar Company Profile: Cottage, Newtimber Place Lane, Newtimber, Ypsomed AG 30. West Sussex, BN6 9BU, United Kingdom. Registered in England: No 05314696. Copyright 2006 OnDrugDelivery Ltd*. The views and opinions expressed in this issue are those of the authors. Due care has been used in producing this publication, but the publisher makes no claim that it is free of error. Nor does the publisher accept liability for the consequences of any decision or action taken (or not taken) as a result of any information contained in this publication.

5 * except for the article Reducing time to market: successful drug manufacturing 2006 Vetter Pharma-Fertigung GmbH & Co. KG. Front cover image, Validated washing process for aseptically PREFILLED application systems, reproduced with kind permission from Vetter Pharma- Fertigung. The image also appears on page 16 of this issue in Vetter's article entitled: Reducing Time to market: successful drug manufacturing . 2 Copyright 2006 OnDrugDelivery Ltd OnDrugDelivery Pre filled 6/8/06 22:29 Page 3. INTRODUCTION. Some of the cornerstones upon which the grow at a compound annual rate of wild or staggering.

6 PREFILLED syringes sector's growth has been between 2004 and 2011. A major portion They are not going lead built are: ( ) of this revenue is set to come from the to a transformation of fastest growing PREFILLED syringes sector, it medicine as we know it in the same way that, the continuing growth of the injectables adds. Another 2005 publication from Frost and for instance, intelligent biomechanical implants market, underpinned by the growing number Sullivan, The European PREFILLED Syringes and other micro- and nanotechnologies might.

7 Of biotech product launches Market, estimates that the European market Instead, with PREFILLED syringes, we encounter the growing emphasis on safety, particularly for PREFILLED syringes is worth $300 million and measured, solid improvements over previous, sharps safety is growing at 8-10 % per annum . conventional systems. the increasing realisation that a delivery So how have PREFILLED syringes achieved this? There are many examples, but one which system's convenience, speed of use and ease Looking in from outside, almost every aspect of typifies the type of benefit I am referring to is of use benefit treatment outcomes the PREFILLED syringes sector appears balanced that PREFILLED syringes contain the precise the rising numbers of high-cost drugs and well grounded.

8 I believe this is the key. amount of drug that is to be injected. In reaching the market, which make it important For example, in terms of their technological contrast, vials and ampoules have to contain to reduce or eliminate overfill and other complexity, PREFILLED syringes are positioned more liquid than the actual dose in order for the sources of wastage. midway along the spectrum of delivery systems. correct amount to be withdrawn, so the excess They fall between high-technology devices like formulation is wasted.

9 Especially with These and other drivers have been aqueous droplet inhalers or needle-free jet expensive biotech products, elimination of discussed previously in various publications injectors, and simple, low-tech systems such wastage allows the manufacturer to make (including in OnDrugDelivery 's 2005 issue, as traditional syringe and vials, for example, or significant cost savings. PREFILLED syringes PREFILLED syringes: innovations that meet the oral capsules and blister packs. PREFILLED reduce wastage of pharmaceutical product.)

10 This growing demand), and are touched upon in syringes are neither extremely high-tech, high- kind of ostensibly unremarkable advance does several of the articles that follow here. value products, nor are they mere commodities. not typically make the front covers of eminent Growth drivers, although the prerequisite for journals, but the millions of dollars that can be success, cannot bring about success on their own. RISK AND REWARD saved certainly causes drug manufacturers and Organisations must come forward to develop drug purchasers to sit up and take notice.