Efficiently Enhancing Biotechnological Procedures
Fujifilm Diosynth Biotechnologies (FDB), a leading provider of contract biologics, gene therapy, and vaccine process development services, is revolutionising its approach to experimentation. Somaieh Mohammadi, a key figure at FDB, explains that designed experiments are playing an increasingly important role in the organisation.
Mohammadi states that these experiments result in a better understanding of processes and ensure product reproducibility – crucial aspects in today's competitive marketplaces where rapid innovation cycles and adherence to high-quality standards are paramount.
The introduction and dissemination of statistically designed experiments at FDB were led by experts in bioprocess development and quality assurance. Process engineers and statisticians within the organisation have been instrumental in driving this change.
Gwen Ninon, another FDB representative, emphasises the key benefit of this approach: it allows scientists to plan experiments in advance and separate important factors from noise. This efficient approach is vital for optimising process development in biotechnology and pharmaceutical companies, which are under pressure to make processes scalable and reproducible.
FDB, with its locations in the UK, US, and Denmark, offers extensive scientific expertise in cell culture, recombinant proteins, viral vaccines, microbial fermentation, and gene therapies. The company is promoting process innovation through formalised training, individual consulting, and strategic development workflows.
Statistical methods, such as Design of Experiments (DOE), help researchers reduce the number of experimental runs, thereby shortening development cycles. DOE provides a robust framework while shortening development timescales, enabling reproducibility and scalability – essential for the consistent and correct production of high-yielding products.
These efficiencies contribute to the speeding up of development cycles, leading to both profitability and scientific innovation. Mohammadi further explains that designed experiments help FDB make better design decisions, leading to process understanding and product reproducibility.
The use of statistically designed experiments is not limited to FDB. They are playing an increasing role in global pharmaceutical and biopharmaceutical labs, as scientists seek an efficient approach to optimise process development. Mohammadi is also working to establish new data science proficiencies within the organisation, further solidifying FDB's position at the forefront of process innovation in the biotech industry.
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