Tuesday, September 28, 2021 Daily Archives

High-Throughput IgG Titer Analysis

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This webcast features: Zoe Hughes-Thomas, Head Medicine Design Automation Team, and Celal Dari, Laboratory Science Apprentice, GSK Antibodies. A key cornerstone of pharmaceuticals, from oncology to immunology. But how do we quantify them? Existing methods have proven the process needs to be improved, from long assay turnaround times to discordant results. A key method of innovating the process includes embracing new technology including automation and new assays. The presentation will introduce aspects of current methods of automation that aim to…

eBook: Bispecific Antibodies — Their Development and Manufacture As Therapeutics

Generating antibodies with two or more specificities is one of the most innovative fields in therapeutic antibody development, with tremendous potential for use in creating new treatments for patients with unmet medical needs. In particular, bispecific antibody development is stimulating innovations in bioprocessing techniques from expression through upstream processing and candidate purification. Wherever possible, process-development scientists and engineers are borrowing techniques that were honed for mature monoclonal antibody (MAb) platforms, then applying those to bispecific antibody manufacturing. Nevertheless, the unique…

Kuhner TOM For Off-Gas Analysis in Shake Flasks

To facilitate and speed up process- and media development, online measurement techniques for shake flasks accompany manual sampling for maximum information output per cultivation. Off-gas analysis gives oxygen transfer rate (OTR), carbon dioxide transfer rate (CTR) and respiratory quotient (RQ) as quantitative measures of the physiological state of the culture. On shake flask scale, multiple cultivations are usually run in parallel. Off-gas analysis should therefore be cost effective, easy to handle and versatile to match various applications. Therefore, we developed…

Biocon hit by FDA 483 with 6 observations at Malaysian plant

Biocon’s insulin manufacturing facility in Malaysia has received a US FDA Form 483 with six observations but firm says it will not affect commercialization plans in the US. Indian biopharma giant Biocon reported this week it has been issued with a Form 483 by the US Food and Drug Administration (FDA) after the agency conducted an on-site pre-approval inspection (PAI) at its Malaysian  manufacturing plant for its biosimilar insulin product. “The US FDA conducted a (PAI) of our Malaysian subsidiary…

Sartorius expands presence in North America with Michigan plant

Sartorius plans to build a plant in Ann Arbour, Michigan expanding its business operations in North America. German life sciences firm Sartorius is expanding its presence in Michigan with plans to open an 130,000 square-foot facility in the Tech Loop at Ann Arbor Research Park by the end of 2023, creating a flag ship plant for the firm in North America. In total, the firm has purchased over 15 acres of land at an undisclosed price, providing it with sufficient…

Gamma invests in bio-sensor and analytics firm Nirrin

Nirrin’s near-infrared spectrometry platform offers a reliable and cost-effective method of real-time analytics and will be leveraged across Gamma’s growing bioprocessing network, the firms says. Gamma Biosciences’s undisclosed investment in Maryland-based Nirrin Technologies brings access to sensors and analytics that support the bioprocess space, including automation tech with real-time, in-process monitoring for upstream and downstream applications. “This is a structured investment with longer term features that allow Nirrin to leverage Gamma’s resources and network in the near term as the…