DSM Biologics has developed a highly intensified cell culture process termed XD®, which provides cells with a constant environment for optimal cell growth (Figure 1). The XD® Technology works in a continuous media feeding mode with a filtration unit to retain both the cells and the recombinant protein in the bioreactor. Compared with a standard fed-batch process, the feeding regime in the XD® process can be performed with basal media, and this allows straightforward implementation without the need for extensive…

The goal: Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex. The challenge: To engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product. The Outcome: Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to the clinic on time. About…

FrieslandCampina Domo is a subsidiary of the dairy multinational Royal FrieslandCampina, which has 20,000 employees, active in over one hundred countries. Our revenues are over 9 billion Euros. Formerly Known as DMV International FrieslandCampina Domo incorporates parts of the companies formerly known as DMV International Nutritionals and Friesland Foods Domo. These entities have over 75 years of experience in ingredient discovery, development, and marketing. With a new name and an expanded product portfolio, FrieslandCampina Domo is strengthening the presence in…

          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…

Growing commercial demand for therapeutic monoclonal antibodies (MAbs) has increased the need for efficient and cost-effective manufacturing processes. The development of cell cultures with very high expression levels is one clear example. over recent years, the antibody titers of mammalian cell culture have risen dramatically, and today we often see titers of 5–10 g/L. Expression levels as high as 15 g/L or greater have even been reported. Chromatography media (resins) that can capture these high-titer antibodies are therefore essential for…

          Traditional influenza vaccine production uses fertilized hen eggs. This method is labor-intensive and requires large facilities with limited scalability. A switch to cellculture–based vaccine production methods and use of disposable products would provide flexibility to substantially reduce the time to vaccine clinical trials and approval, effectively decreasing the time-to-market. The aim of this work was to establish a process to propagate influenza virus in Vero cell culture using animal-component–free conditions for cell growth and disposable…