Friday, August 24, 2018 Daily Archives

Preventing the Risk of Contamination with a Robust System for Anaerobic Testing

Environmental monitoring, product quality control, and mycoplasma testing of biopharmaceuticals require anaerobic bacteria monitoring. If the proper environment is not created when performing microbial testing, bacteria will not grow, and a possible contamination could be missed. Any bacterial contamination of biopharmaceutical products can have major negative effects on manufacturing, production costs, and profit margins. A technology that relies on the evacuation and replacement of oxygen in a jar is valuable to the biopharmaceutical industry because it creates a quality-assured anaerobic…

Horizon’s Alternative CHO K1 GS Knockout Cell Line Drives Access to Cutting-Edge Biomanufacturing Cell Lines

Chinese hamster ovary (CHO) cells are the expression system of choice for the manufacturing of biotherapeutics. They have the capacity to express a range of proteins such as therapeutic enzymes or monoclonal antibodies at multiple gram per liter titers. As expression technologies have developed, obtaining such titers has been achieved mainly through improvements to media and feed. Similarly, the ability to identify high-productivity clones has been streamlined through the use of different selection systems, with metabolic selection being the preferred…

Purification Control Systems for Every Step of the Development Process

Early stage development of biological unit operations is critical to ensuring an efficient and robust commercially viable process. Often, the types of experiments required in early stage development are arduous tasks that require extensive testing of different critical process parameters, filters, and other essential production components. Such testing inherently produces massive amounts of data that must be carefully analyzed. To streamline the development process and optimize operational efficiency, PendoTECH has developed a full offering of control systems specifically designed for…

Efficient Bioprocess Development with Online Analytics and Data Management

As an engineering company, we are optimizing and developing new technologies for more efficiency in bioprocessing. Building on over 25 years of experience in online analytics, information processing, and automation technology, we aim to be the trusted technology provider for optimized workflows through automated sampling and process information management. Who We Are Securecell emerged in 2009 from the company Biospectra, which was founded as a spin-off from ETH Zürich in 1992. Ever since, development of online analytic solutions for bioprocess…

Acidic IgM Purification with a New Anion Exchange Resin

IgM antibodies are one of the fastest growing groups of diagnostic and therapeutic candidates. Unlike IgGs, IgMs cannot be purified by affinity chromatography due to their physiochemical properties. The large size of IgMs presents an additional purification challenge. Bio-Rad has developed a new strong anion exchange (AEX) resin — Nuvia HP-Q — to overcome the multiple issues faced when purifying large biomolecules. We show the purification of an acidic IgM antibody with capture purification using Nuvia HP-Q and polish purification…

Yang Zhi

A Platform Production Process for Manufacturing Viral Vector and Vaccine Therapeutics Using Vero Cells

Yan Zhi, program design technical lead, Fujifilm Diosynth Biotechnologies Fujifilm Diosynth Biotechnologies (FDB) is a world-leading contract development and manufacturing organization (CDMO) with over 25 years of experience using biologicals and more than 310 projects including six licenses. Production sites are located in North Carolina and Texas. In Texas, the flexible biomanufacturing facility can handle production from preclinical to current good manufacturing practices (CGMP) commercial manufacturing. Facilities and capabilities include state-of-the-art process development; mobile cleanroom (MCR) technology with fully segregated…

BioProcess Insider BPI Theater @ BIO 2018 Interviews – Tuesday

BioProcess Insider brings the news as it breaks. At the BPI Theater @BIO, editor Dan Stanton conducted a series of interviews live on stage to report on the latest movements in the biomanufacturing industry to start each busy day of dealmaking in Boston. Below we summarize his DAY ONE conversations with a number of biopharmaceutical executives on Tuesday 5 June 2018. You can watch the full interviews online at www.bioprocessintl.com/BIO-Theater-2018. Andy Topping, Chief Scientific Officer, Fujifilm Diosynth Biotechnologies Gene therapies show…

Manufacturing Automation for Patient-Scale Cell Therapies

Nina Bauer, associate director of autologous cell therapy commercial development, Lonza Pharma and Biotech Lonza Emerging Technologies is focusing on cell and gene therapies. Lonza now has expertise in different cell and vector types, constructs, process and assay development, and platform technologies for both clinical and commercial manufacturing. This includes taking a concept through commercial manufacturing. Lonza just opened a site in Houston, TX, and another in the Netherlands, as well as partnering with Nikon in the Asian market. Cell…

Kyowa Hakko fermentation plant hit with FDA warning

Kyowa Hakko has received a US FDA warning letter citing GMP and data integrity issues at its amino acid production facility in Yamaguchi, Japan. The warning letter dated August 10 2018 came following an inspection of Kyowa Hakko Bio’s Hofu facility in September 2017 by the US Food and Drug Administration (FDA). Deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API) cited by the Agency included failures in Kyowa Hakko’s quality unit, along with a lack of…

Freedom of innovation: GE opens $17m Swedish biotech testing center

For around $6,600 per week, firms will have access to bioprocessing laboratories and equipment to test their biotech innovations. “The innovative and entrepreneurial environment also provides important input to the GE culture,” says GE Healthcare. A €10 million ($11.6 million) investment by the Swedish government coupled with €4.5 million from life sciences vendor GE Healthcare has led to the opening of an innovation testing center at the latter’s site in Uppsala, Sweden. Named the Testa Center, the facility allows access…