We were lucky to have two new experts, a food and feed regulation professional and a bioinformatics specialist, join our Biosafe team this year. We interviewed them about their work, global trends and the art of getting EU approval for your product.
1. Food and feed regulation expert
Anne Ukkonen is a Regulatory Manager focusing on European food and feed guidelines. For our customers, this could mean knowing and explaining the guidelines under which the authorities and EFSA experts assess your product and what the testing and analysis requirements for your product are.
Anne has been working in the biotech industry for about 20 years both as a scientist and a manager. She started her career at the University of Eastern Finland, in professor Sirpa Kärenlampi's research team. Since completing her PhD in biotechnology, she has worked in the private sector as a project leader in a biotech company battling cancer and as a quality control manager in a company producing gene therapy and virotherapy products. She has hands-on experience in a wide array of laboratory techniques both as a researcher and supervisor, and she is well experienced in working in a GMP (good manufacturing practice) environment and what it entails.
2. Bioinformatics expert
Lars Granlund is a Project Manager focusing on bioinformatics. He works with the Biosafe laboratory to analyse samples and bioinformatics concerned with the acquisition, storage, analysis, and dissemination of biological data sets, most often DNA and amino acid sequences. He also communicates with clients, writes up reports and manages a diverse range of projects.
Lars has a PhD in imaging techniques in ecological applications and his broad background is in biology, biochemistry and environmental sciences.
3. Organisers of the right data
Anne Ukkonen: Familiarising ourselves with and keeping up to date with EFSA guidance and EU legislation is key for Biosafe to be able to help our clients. I am involved in client projects, for example by carrying out literature reviews, a gap analysis for a client's application material or preparing a section or a complete dossier for an application on behalf of a client.
Our clients have a huge range of different products, production organisms and processes. I find them truly captivating. In this job, you are right at the front line, seeing what is being developed around the world. The best part of our client projects is when we can solve a difficult problem and produce a study or report that is EFSA-ready or otherwise required by the client, and the client can move forward with their product.
Lars Granlund: Bioinformatics is an essential part of many EFSA risk assessments. It combines computer science, statistics, mathematics and engineering to study and process biological data. Because clients' needs differ, every project is different with a varying set of challenges. Client work is an essential part of the job description and I try to keep contact with clients at a low threshold. Indeed, clients often contact me when they are planning their needs and communication is actively maintained throughout the project.
4. Participants in the global conversation
Lars Granlund: Food and feed safety regulations are constantly evolving. They aim to both ensure safety in the food chain and facilitate bringing new and innovative products to the market. Teams with professional scientists and policy experts like Biosafe have an increasingly significant role in knowing how the science and regulations are evolving and what needs to be done to expedite the process.
Anne Ukkonen: The spread of antibiotic resistance is a topic of international importance and is constantly on the agenda. AMR is also on the top of my mind at the moment due to my recent study of antibiotic resistance genes in client projects. More is being learned all the time, but a quick perusal of the literature showed that there is also a great deal that remains unexplored. While research has rightly focused on clinically important microbial species, there is often limited information available on microbes used as production strains in food and feed. The discovery of a single antibiotic resistance gene in the microbial genome may not be relevant to the development of antibiotic resistance, but expertise is required to understand the overall picture and interpret the results. This is where Biosafe can also help our customers.
5. A committed scientific team
Lars Granlund: I have worked with many Biosafers in the past and I knew that this was a great opportunity to work in a driven atmosphere with top scientific experts, who pool together a huge variety of biotech knowledge and experience. Especially my close colleague Jenny Makkonen, who is also a bioinformatics expert as well as a researcher of molecular biology and genetics, is a marvel. Even in the most challenging situations, she always responds with unflinching calm, a positive attitude and strong expertise of the subject matter.
Anne Ukkonen: The variety of opportunities, the interesting subject matter and the lovely colleagues made me take up the job opportunity at Biosafe. Biosafe's professionals have all impressed me with their expertise. I have also been very impressed by the very broad knowledge of our Managing Director Pauliina Halimaa in many areas and her knowledge of EU legislation and EFSA guidance. Not only does she lead our company with a very positive approach, but she is also a real biotech expert and challenges the rest of us to stay on top of our game.
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