Essential for R&D of new medicines
Before a new medicine can be marketed, it needs to undergo safety and efficacy testing with healthy volunteers (phase 1), smaller groups of patients (phase 2) and larger groups of patients (phase 3). Once the medicine marketed phase 4 testing happens. The medicines for this type of research (clinical trials) are prepared by the Clinical Supplies Unit.

Customers Worldwide
The Clinical Supplies Unit is part of the ChemPharm organization, responsible for the development and supply of new medicines. The Clinical Supplies Unit is responsible for the coordination, packaging, labelling, and distribution of all medicines for global clinical trials, from phase I to phase IV. Customers are within Johnson & Johnson Pharmaceutical Research & Development, Drug Evaluation and Drug Development (phase 1 to 3), Medical Affairs of Janssen-Cilag, the American Janssen Pharmaceutical Inc. (JPI), Ortho Biotech (OBI) and Ortho McNeil, and Tibotec.

Clinical supplies
And the safety of the patient and the validity of the data are top priorities for the clinical studies of Johnson & Johnson Pharmaceutical Research and Development (J&JPRD). For this reason, Johnson & Johnson has been deliberately limiting outsourcing of the clinical supplies more and more often. Because the operational Clinical Supplies Unit (CSU) in Beerse now accounts for 80% of the volume of the clinical supplies for J&JPRD, an expansion and re-furnishing of the existing infrastructure became imperative. In addition, the latest GMP (Good Manufacturing Practices) regulations are being met with this investment − regulations that are becoming more demanding all the time.

Primary and secondary
CSU handles both ‘primary’ and ‘secondary’ packaging. The primary packaging consists of packing tablets and capsules in. In the secondary packaging, the blisters individually labelled and packaged for each patient. When the CSU building was inaugurated in 1992, it was state-of-the-art. However, in accordance with the GMP regulations in effect at that time, the primary and secondary packaging were done in the same building (of course, with separate air treatment systems). Today, the more stringent regulations demand the two activities to be separated to preclude (cross-) contamination. Along with the complete re-furnishing, the surface area of the existing CSU building has been expanded from 3650 to 6150 m2 and the number of work modules has risen from 15 to 27. Cost: 15 million euro.

J&JPRD sets the pace
J&JPRD now has everything in-house to handle all this itself − not least of which are the extra high-tech machines that have been installed and validated and are able to handle even the most complex scientific study designs. The computer-controlled machines ensure flawless packaging under one and the same blister. Important for the validity of the study results by virtue of the increased patient compliance. And important for the patient him/herself, who can now hardly make a mistake in the intake of the medications under investigation.

More. Better.
The surface area of the CSU building is nearly doubling, as is the number of work modules. The 3 modules for primary packaging are now 5; and the 12 modules for secondary packaging have been increased to 16 − 5 of them being taken up by packaging machines and 11 by labelling. In addition, there are 2 areas for processing orders and 4 staging areas: loaded with interlocks for bringing in and discharging goods in accordance with GMP regulations.
But the CSU unit is not resting on its laurels. In a companion project, SPIDER has been developed − the IT system that will link and globalise all other IT systems. And that’s not all: investigations have already begun to identify new technologies that will be able to raise patient compliance and lower costs even further.

You
The re-furnishing provided the opportunity to organise activities in an ergonomic U-shape, which optimises the process flow. After primary packaging, the product can take one of two paths: directly to the secondary packaging for finishing, or to the temporary storage. This avoids the process of keeping interim stock in other areas.

On time, on budget
J&JPRD is proud both of its renovated CSU building and in the way in which its construction was handled. During the two years of renovation, production did not stop for a single day. A feat that required sophisticated planning plus a great deal of flexibility on the part of the employees.
In one fell swoop, all the product coordinators, who were formerly spread over the Beerse campus, have been brought together in brand-new offices − where they gather the requests from the internal customers and ‘translate’ them into the operational plan.