No single strain or vector is capable of being the best expression option for all types of biopharmaceuticals. The XS Systemâ„¢ ultimately decreases the time of strain screening and design to enable the fast creation of a valuable production strain and efficient cGMP process.
A Decade of Production
Single-use technology has arguably been the biggest “story” of the past 10 years in bioprocessing. And for many people, implementation of disposable elements began soon after the turn of the century with a bioreactor (1, 2), first developed by Wave Biotech in 1996, now a mainstay of many upstream process development laboratories and sold by GE Healthcare. BPI identified the significance of such technologies early on, making them the subject of a supplement in its second year. By the fourth…
Eukaryotic cells are fragile and finicky, requiring very specific culture conditions and nutrients to survive, grow, and be productive in an ex vivo environment. Even so, they have become vital to the biopharmaceutical industry’s ability to make complex biological products — overtaking yeast as a production system around 1990 and surpassing bacteria in the number of associated product approvals five years later (1). Since then, they have become even more useful, expanding their reach into the vaccine world. Mammalian cell…
Fluid Management Product: BioFlex tubing Applications: Single-use bioprocessing Features: Meissner’s BioFlex tubing assemblies provide secure fluid paths for single-use systems and scale to allow flow rates >100 L/min. The tubing also connects disposable and stainless steel process equipment. Customizable assemblies can integrate sterilizing-grade through clarification-grade capsule filters. BioFlex products come sterile and ready to use, incorporating required tubing materials, connectors, filters, pinch clamps and other specified components. Pre- and postuse integrity testing procedures also can be accommodated. Contact…
As the biopharmaceutical industry in China continues to grow, the corresponding demand for high-quality, tactical information and proven strategies continues to increase. Although many people see China’s current technologies and skillsets as lagging behind those of more advanced counterparts in North America, Europe, and Asia, the Chinese industry’s thirst for knowledge and eagerness to adopt and adapt new techniques have enabled it to leap-frog development at an astonishing speed. At IBC’s fourth annual BioProcess International China event, the goal is…
Outsourcing has been such an integral part of the bioprocessing industry that BPI made it the focus of its first supplement (September 2003). Since then, manufacturers continue to reach beyond local and national borders to extend their networks of partnerships to emerging markets. Global economics during the past decade have not always made outsourcing easy. Ten years ago, manufacturers faced tough decisions over whether it was more cost effective to outsource or keep process activities in-house (possibly expand…
Protein hydrolysates are widely used in mammalian cell culture to improve cell growth and recombinant protein production. However, use of the hydrolysates can lead to significant process variability, due to the limited control of their source and final composition during manufacturing. On the other hand, development of chemically defined media and feeds requires a tremendous amount of work, including comprehensive library screening and spent media analysis.
In this educational webcast, Dr. Hao Chen, Associate Principal Scientist, BioProcess Development at Merck, describes a rapid method for developing chemically defined media and feeds for Chinese hamster ovary (CHO) cell lines from existing proprietary media and feeds by the replacement of basal protein hydrolysates with novel supplements. In the case studies presented, Dr. Chen shows that after two rounds of optimization, the protein hydrolysate was successfully replaced. The resulting cell growth, protein productivity, and product quality were similar in the chemically defined and original media. The entire development process was completed within six weeks.
Affinity Chromatography Product: CaptureSelect affinity ligands Applications: Antibody-based separations Features: BAC BV has teamed up with both Life Technologies and GE Healthcare to supply them with CaptureSelect antibodies for use as chromatography ligands. Life Technologies has launched a 0.1- to 7.9-mL range of POROS columns for analytical chromatography for IgG, IgM, human serum albumin fusion proteins, and antibody fragments containing κ or λ light chains. GE Healthcare has added LambdaFabSelect for GMP purification of antibodies and fragments that contain λ…
This conference offers solutions toward better industry cooperation in standards harmonization and downstream processing. New applications for disposables in fill–finish and bulk storage will be covered through a series of case studies, panel discussions, point–counterpoint debates, and breakout-discussion roundtables. Program Highlights PDA Task Force for Single-Use Systems will outline a technical report overview and concepts focused on extractables and leachables. Genentech will disclose additional data from experiences with disposable bags for cell culture media storage. A panel of experts from…
Live Cell Imaging Product: DeltaVision OMX Blaze system Applications: Cell and protein research Features: Applied Precision, a GE Healthcare company, offers the world’s first microscopy system for capturing high-resolution video of live cells in three dimensions. The DeltaVision OMX Blaze system’s speed of image acquisitions enables researchers to follow tagged proteins within the same living cell over time in 3D space at near-molecular resolution. The 3D structured illumination microscopy technology roughly doubles the resolution of fluorescent microscopy methods — for…