A dynamic environment where new medical products take shapeMelissa2024-08-06T22:32:08+02:00 A dynamic environment where new medical products take shapeFor 10 years, Artelia has assisted AGC Biologics who handles important steps in the comprehensive innovation process that characterises product development in the biopharmaceutical field. In the process of developing new medical products, it is a long way from when the first innovative idea is born in a research laboratory to a new medical product reaches the market. The process consists of several stages, and AGC Biologics specialises in helping pharmaceutical manufacturers in a number of the stages where the potential of new ideas must be explored and tested. Globally, the company is a leading biopharmaceutical CDMO (Contract Development and Manufacturing Organisation). This means that AGC Biologics can also handle the actual production for the customers. Since AGC Biologics produces and develops for other players, they have to be adaptable, which of course affects our work. It is a good example of the great flexibility you must have as a consultant in an industry with constant innovation. Morten GravgaardBusiness ManagerProject Execution – Pharma Design on the users’ terms As Morten points out, the tasks illustrate the width of the qualifications in our Pharma & Life Science division. We are usually involved right from the early idea development and conceptual design to the implementation of the technical facilities. This can be seen in one of our latest projects, which involved setting up a downstream laboratory in existing office premises. At an early stage, our process architects helped design the facilities and production flow right down to the individual work station in close collaboration with laboratory technicians and researchers. Based on user input, several suggestions were drawn up for the future layout, and that gave great value, says Pernille Susgaard, who is department manager for Process Architecture : Our inspiration comes directly from the users themselves, but we also have good experience with using that knowledge to set up several alternatives. They are often positively surprised to see how we can accommodate their needs even better in a completely different way than what they had originally imagined. It is layout on the users’ terms, but at the same time, we must use our expertise to offer a new perspective. Therefore, both the fourth and fifth user meetings are valuable. As Pernille explains, the user experience must also be combined with the consideration for an efficient work flow and the many requirements that the biopharmaceutical field is subject to, including cGMP (Current Good Manufacturing Practice). Scan to BIM The conversion to laboratories required an upgrade of the ventilation system, which meant significant changes to a densely packed technical floor that supplies several parts of the building. At the same time, it was therefore necessary to establish a temporary supply facility that could uphold the operation of a critical production area while the other measures were implemented. For several reasons, it was an advantage to carry out a 3D scan of the entire technical floor. The facilities were laser scanned in combination with a 360° photo registration to get a precise picture of the work area as a point cloud, which formed the basis for modelling both the current and future installations in Revit. By using the programme Revizto, both model and point cloud could be taken on the go, which made it easy to scrutinise the details on the site. An intensive summer shutdown The 3D model was one of the tools we used when planning an efficient construction process, which had to be carried out in 18 days during a summer holiday, during which operations were disrupted as little as possible. Shutdown is a discipline in itself, as everything must be organised in detail. It requires careful planning, an understanding of the mechanical processes and insight into the industry’s workflows, which our pharma specialists have. Just establishing a construction site alone is a challenge, as all work routes must be placed in a way that does not in any way compromise the requirements to cleanness in other areas. It requires very precise plans for how materials and craftsmen must enter and leave the building, Pernille explains. Clean production environments In the same property, Artelia has helped establish the actual production facilities. This comprises a so-called 6-pack unit with six bioreactors, made for single-use technology, which is replaced each time AGC Biologics has to produce a new product for a customer. Production takes place in cleanrooms, which we have designed based on all the common regulations such as cleanability of the highest standards and a downward air flow, which means that the ventilation is established as floor suction. The ventilation qualification is also essential in our design of locks and changing facilities for the clean environments. Here, there is either positive air pressure or negative air pressure in the different rooms to eliminate the risk of particle contamination and cross-contamination. The entire layout is of course covered by the cGMP requirements that apply in all geographic markets that AGC Biologics operates in. The complexity of the technique The machines in the production machinery are another one of our core qualifications. The process facility normally consists of custom-made deliveries with special requirements, and our machine specialists’ job is, among other things, to design the many necessary supplies such as heating, cooling, electricity and water. During implementation, they help with testing, commissioning and, not least, qualification, which is the process by which it is confirmed and documented that the equipment comply with the requirements for pharmaceutical production. In construction projects, the technical equipment is an important variable in a large picture, where factors change constantly due to the dynamics that characterise the activities of AGC Biologics and the pharmaceutical industry in general. As a client consultant, I have helped assess the purchase of equipment, and it is obvious how the needs change constantly during the process. Our starting point must be that the design is not fixed until the construction is actually completed. Pernille SusgaardHead of DepartmentProcess Architecture – Pharma Pernille is supported by Morten : The prerequisites change all the time, and we therefore have to be very clear about the professional considerations behind each and every decision, so that we can go back and argue professionally for the choices that have been made. By having control of every link in the decision-making chain, we can better assess the exact consequences that a new change will entail. So, in addition to flexibility, the dynamics require a very high level of structure.
