Bioproduction in Need of Change : An investigation of the needs and bottlenecks of the biomanufacturing industry

Sammanfattning: This report was conducted at the request of Testa Center to compile the essential requirements and challenges faced by the biomanufacturing industry. The gathered information will serve as a guide for Testa Center's future objectives in accelerating technological advancements in bioproduction. Based on insights provided by 14 companies involved in various stages of biological production, a comprehensive conclusion was reached. A bioproduction process was defined to encompass cell optimization, creation of starter cell cultures, cell cultivation/fermentation in bioreactors, product harvest, clarification, capture, and polishing, with the latter three stages focused on purification. The companies were contacted through surveys and personal interviews, which were tailored to suit each interviewee while aligning with the survey questions. Data obtained was subsequently categorized, highlighting the areas in need of significant development, where frequency of mentioned bottlenecks within each category determined its level of importance. According to the companies, the three most critical areas requiring attention were purification, continuous processing, and single-use technologies. Consequently, these areas were given thorough consideration during the analysis of individual company responses. However, all bottlenecks raised by company representatives were included, along with relevant background information to ensure a comprehensive understanding of each issue. The remaining areas of need, in descending order of significance, were classified as "miscellaneous" (bottlenecks not assignable to a specific area), "scalability", "cooperation and communication", "cell optimization and gene-editing", "other material and equipment issues", "high costs", "screening and assaying", "harvest", "bioreactors", and "virtual modeling". The expressed needs varied depending on each company's unique biological production process. By addressing these identified challenges and focusing on the crucial areas, Testa Center can effectively contribute to the acceleration of technological advancements in bioproduction.