Author Archives: Stewart McNaull

Covering a Spectrum of New Product Development Technologies: From Cells to Cell Therapy

Presented by Stewart McNaull (senior vice president of business development, KBI Biopharma) 11:40 am–12:00 pm Founded in 2004, KBI Biopharma operates a core facility in Durham, NC. In 2013, the company needed more space and set up laboratories in Research Triangle Park, NC. Using mammalian cell lines, it has developed both monoclonal antibody (MAb) and non-MAb platforms. It acquired a former Merck site in Boulder, CO, in 2014 and retained staff experts in fermentation expression, refolding, and mass spectrometry. With manufacturing…

Efficient Strategies to Deliver Reliable and High Quality Biomanufacturing Processes Through Optimization of Cell Culture Media, Feeds, and Process Parameters

Development of a reliable and high quality biomanufacturing process for recombinant CHO cell lines presents challenges from diverse nutritional requirements observed with different clonally derived cell lines, and variable response to process operating ranges. To address these challenges, we will discuss efficient approaches to optimize CHO cell culture media, feeds, and process parameters within FUJIFILM Diosynth Biotechnologies (FDB). Also discussed is FDB’s new ApolloTM CHO expression system, a cornerstone of process scale-up efficiency offering robust gene expression in a platform…

Focused Process Development for Reliable Biomanufacturing: Experience and Innovation in Cell Culture

Fujifilm Diosynth Biotechnologies (FDB) leverages over 15 years of experience in bioprocess development and manufacturing to successfully deliver robust process designs to its clients. FDB has executed a series of innovation programs to enable rapid development of cell culture processes, including the coming launch of a new Chinese hamster ovary (CHO) expression system. This application note describes how outputs from media screening and upstream process development innovation programs were applied to provide significant productivity and process robustness improvements to an…

A CMO’s Approach

          Industry leading biologics contract manufacturer Fujifilm Diosynth Biotechnologies located in Research Triangle Park, NC (formerly Diosynth Biotechnology) and in Billingham, UK (formerly Avecia Biologics) provides third-party contract development and manufacturing services to the biopharmaceutical industry. Fujifilm Diosynth Biotechnologies has supplied clinical and commercial recombinant proteins produced in cell culture for more than 14 years. We have extensive experience in microbial development and manufacturing and equal experience in the cell culture space. Our development experience includes…