Pharmaceutical-technological expertise ensuring successful drug development projects and manufacturing of IMPs

Jukka Ilkka

Jukka Ilkka works as a Scientific Advisor and Production Manager in Medfiles’ R&D and Analytics Unit in Kuopio. He is trained as a pharmacist specialising in pharmaceutical technology and has decades of experience in pharmaceutical manufacturing, which he has worked on throughout his career in pharmacy.

Jukka has been working at Medfiles for more than 25 years. He joined Medfiles in 1998 as a Pharmaceutical Product Development Specialist. In this role, Jukka gained knowledge and experience especially from a technological and technical perspective.

“At the beginning of my career at Medfiles, I did research on material properties, especially in the field of tableting. I worked on a daily basis on issues such as tablet presses and the measurement systems and PC applications built for them. This provided technological and technical insight into product development, especially for solid dosage forms such as tablets.”

Jukka’s role and responsibilities as a technological expert have included everything from looking at a single technological problem to a full pharmaceutical development project for a new medicinal product.

Today, Jukka works in two roles at Medfiles. He is a Scientific Advisor in pharmaceutical R&D services.

“My work largely consists of expertise in pharmaceutical and technological issues. My most typical assignment is a new product development project or a more narrowly focused consultancy on pharmaceutical-technological or quality aspects of products or processes. I am particularly interested in being present throughout the lifecycle of projects, from the negotiation and planning phase to the practical implementation and management of the project, often including the resolution of specific technological issues.”

Jukka also works as a Production Manager in clinical manufacturing services. Jukka is responsible for the framework and practices of manufacturing investigational medicinal products (IMPs), as defined by the current authorisation. The manufacturing of investigational medicinal products is fully compliant with the principles of industrial pharmaceutical manufacturing as required by current legislation and guidelines, but on a smaller scale than commercial manufacturing.

Especially in investigator-initiated studies (IIS), appropriate pharmaceutical-technological solutions play a key role in evaluating the composition or design of an investigational medicinal product, considering both its intended use and its cost and cost-effectiveness. Regardless of the scale and technical solutions, the same safety principle applies to the manufacture of investigational and commercial medicinal products – quality cannot be compromised.

According to Jukka, the pharmaceutical industry is highly regulated, which requires a lot of routine in maintaining and developing the working environment. On the other hand, there has to be room for creativity in product development.

“Thanks to this, I find my working environment meaningful. The structured environment, culture, and creative work are well balanced. Continuous and inevitable technical/technological progress must be taken into account, both in pharmaceutical manufacturing, in its materials and techniques, and in the general environment, for example in information technology applications, such as the potential of AI-based solutions. From this point of view, developing expertise is an ongoing process.”

Jukka emphasises that successful implementation of tasks often requires teamwork, where the input of colleagues plays a crucial role. He says that at Medfiles, collaboration is natural and effective, enabling the most challenging problems to be solved and optimal results to be achieved.

Medfiles provides comprehensive GMP-compliant chemical and microbiological analytical services under GMP licence. Our laboratories have been GMP-certified and operating under a GMP licence since 2005. Our GMP licence also covers manufacture of investigational medicinal products for clinical trials. Our expert team provides pharmaceutical product development services from early clinical phases to marketing authorisation, for both human and veterinary products.

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