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Pharmaceutical Manufacturing and Packing Sourcer

High Demands

As early as 1747, the Scottish marine physician James Lind conducted a controlled comparative study on the treatment of scurvy. At that time, he was neither interested in randomised trial design, ethical principles nor legal norms. Over the following centuries, the complexity of clinical trials steadily grew, from the development of statistical methods to multinational alignment with current regulatory frameworks such as Annex VI (1). Additionally, today's companion diagnostics, orphan drugs and, above all, biopharmaceuticals require further measures in terms of quality, efficiency and safety. Biotechnology products are critical in that respect, but they are expensive and complicated to manufacture, require low temperatures and are usually administered in prefilled syringes. These characteristics have to be taken into account by all participants in the modern trial supply chain by sponsors, CROs, contract manufacturing organisations, depots and sites, down to suppliers of secondary packaging.

Labelling of Biopharmaceuticals

However, due to the success of biotech products, this effort is paying off. According to a study conducted by the Tufts Center for the Study of Drug Development, biopharmaceuticals accounted for 35% of all new drug approvals in the US from 2006 through to 2016 (2). The FDA approved 225 new biotech products between 2000 and 2016, compared to 304 small-molecule drug authorisations during the same period. The annual pace of 13 new biotech product approvals accelerated to more than 20 per year between 2014 and 2016 (3). Accordingly, their market value already reached US$68 billion in 2016.

Demanding Labels
Clinical studies involving biotech products are a good example of growing complexity. New requirements are emerging for labelling. Only papers, films, adhesives and inks that are permanently temperature- and moisture-resistant are being used. Furthermore, prefilled syringes are becoming increasingly popular because they represent enhanced safety, accuracy and ease-of-use compared to conventional vial and ampoule packaging. This also explains why the clinical trials government database at the US Department of Health has recorded a steady rise in the use of prefilled syringes in trials (4). However, the space available for marking syringes is limited, which is why booklet or wrap-around labels are recommended for multinational trials where labelling has to contain all the national languages required by law. Thanks to partial neutralisation, these labels can be wrapped around syringes several times to create sufficient labelling space directly on investigational medical products (IMPs).

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As Business Development Manager for Faubel in Northern Europe, Anthony Morrow is based at the companyís central UK sales office in Northampton, covering the UK, Ireland and Scandinavia region. He is a qualified engineer with extensive background in product development. Since joining Faubel in 2014, Anthony's primary focus has been to build awareness for the firmís capabilities in clinical trial labelling among prospective, existing and past clients. Furthermore, he is committed to improving business partnerships, while developing and maintaining substantial client relationships.
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Anthony Morrow
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