Upstream Processing

Automation of Microbioreactors

Current methodologies in genetics and microbiology enable researchers to influence metabolic pathways of microbial cells in many directions. Beside the academic interest in investigating fundamental functions in metabolic pathways, commercial production of valuable compounds by microbial hosts is state of the art. For example, such products include enzymes (lipases, proteases, phytases), therapeutic agents (insulin, antibodies), bulk chemicals (lysine, glutamate, citric acid), or the microbial cells themselves (used in brewing or milk processing), with therapeutic agents probably the fastest growing market.…

Mirus TransIT-PRO® Transfection Kit for Biotherapeutic Protein Production

Decrease time to produce usable protein by maximizing target protein yields through transient transfection. The TransIT-PRO® Transfection Kit uses animal origin free components designed for high and reproducible nucleic acid delivery into suspension CHO and 293 derived cells. Since it is compatible with varied media formulations, the same media can be used for both transient and stable expression. The TransIT-PRO outperforms linear PEI in protein yield, while providing a cost-effective alternative to FreeStyle™ MAX and 293Fectin™ Transfection Reagents.

Scale-Up of Adherent Vero Cells Grown on Cytodexâ„¢ Microcarriers Using ReadyToProcess Equipment

In cell culture-based vaccine production, scale-up of adherent cells is challenging. This study shows a process for scaling up adherent Vero cells from static cell factories to influenza production at 50 L scale using WAVE Bioreactorâ„¢ systems and ReadyToProcess singleuse equipment. Vero cells were grown to high cell density on Cytodex microcarriers in 10 L working volume. The cells were detached with trypsin and used to seed a 50 L production culture with the same microcarrier concentration. The cells were allowed to reattach and grow on the new microcarriers in a larger Cellbagâ„¢ bioreactor chamber. Cells were subsequently infected with influenza virus. The results show a repeatable scaleup procedure.

How cells grow, the discovery of the insulin like growth factors

Find out how a misconception lead to the discovery of grow factors, the insulin-like effects (involving several Nobel laureate), and understand why the surprising side effect of insulin can be employed as a substitute for the natural growth factor as nearly universal growth factor in cell culture.

Profitability in the Biosimilars Market

The biosimilars space offers significant commercial opportunity. About US$60 billion of branded biologic sales will lose patent protection over the next few years, including some of the largest-selling monoclonal antibodies (MAbs). Companies are jostling among themselves, each seeking the best position to exploit that opportunity. Regulators are creating and refining the necessary pathways to success, alliances are being forged, and companies are being acquired. Despite the significant opportunity for biosimilar MAbs, significant risks remain. Perhaps the most significant of those…

Drug Products for Biological Medicines

The California Separation Science Society (CASSS) held a Chemistry, Manufacturing, and Controls (CMC) Strategy Forum on drug products for biological medicines in July 2012 in Bethesda, MD. Topics included novel delivery devices, challenging formulations, and combination products. This CMC Strategy Forum aimed to promote an understanding of how best to increase the speed and effectiveness of drug product and device development for both large and small companies. Participants focused on areas that improve the likelihood for regulatory success, reduce risk,…

A Salt-Tolerant Anion-Exchange Chromatography Sorbent for Flexible Process Development

In most downstream purification processes designed for biopharmaceutical drug production, dilution and diafiltration sequences are unavoidable. Such operations are routinely used to adjust a feedstock or chromatographic fraction to the optimal conditions required for best process performances. Nevertheless, those steps are often time, water, and labor consuming without participating directly in final product purification. Because biopharmaceutical production is increasingly driven by cost reduction, a possible means for enhancing process economics is to streamline purification by eliminating these unit operations before…

Concerns, Collaboration, and Capacity

The BPI Theater is a 50-seat venue that for seven years has been located at the heart of the BioProcess Zone on the exhibition floor of the BIO International Convention. There, BPI provides attendees with four days of live presentations focusing on the latest scientific advances and business trends in biotherapeutic development and manufacturing. On Monday afternoon, 22 April 2013, Patricia Seymour of BioProcess Technology Consultants (BPTC) moderated a roundtable discussion on biosimilar development in the BPI Theater at BIO…

Overview of a Scale-Up of a Cell-Based Influenza Virus Production Process

The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. A brief discussion around modern vaccine processes is followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology. Single-use equipment enables quick changeover between products, minimizes risk for cross-contamination between batches, and reduces the need for cleaning and validation operations.

Broadening the Baseline

When the editors of BPI asked us at BPSA to put together a content-rich article on single-use issues, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy. Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and speak as directors of the alliance. Their…