Thursday, November 3, 2022 Daily Archives

Shaken, Not Stirred: Rocking Motion Versus Impeller Technology and What is Optimal for Cell Cultivation

This webcast features: Tobias Schenk, PhD, Product Manager, Rocking Motion Bioreactors and Consumables, Manufacturing BT Instruments, Sartorius Stedim Biotech. Cell cultivation might be a laborious process, requiring optimization at various stages to achieve the desired cell densities and satisfactory yields of the final product. Optimization steps can be undertaken by improving cell culture media and buffers, inoculation cell densities, as well as specific cultivation run parameters such as temperature, pH and DO values, or changing the duration of the run…

Critical Steps to Consider During Customized Host Cell Protein (HCP) ELISA Development

The manufacturing of recombinant drugs requires comprehensive monitoring of process-related impurities, such as HCPs, as they may pose a significant health risk to patients. EMA and FDA approval relies on robust analytical data to prove acceptable HCP clearance. The enzyme-linked immunosorbent assay (ELISA) is the gold standard method for monitoring HCP content during product development and batch release testing within clinical and commercial phases. Supporting data from various orthogonal methods, including 2D Western Blot/2D DIGE analysis and mass spectrometry, should…

From Integrated Engineering to Integrated Operations: Solutions For Live Operation

From Integrated Engineering to Integrated Operations: This innovation step extends the digital value chain to include the operational phases of a pharmaceutical plant. In the last few years, ZETA has developed a digital toolbox and methodology and established the Smart Engineering Services. Faster time to market, greater cost-effectiveness and competitive capacity are the customer’s motivations for prompting ZETA to develop this proposal. End-to-end engineering, feasibility studies, concept, basic and detailed engineering up to fabrication and qualification are included in the…

Video news: Tosoh launches multi-column chromatography tech at CPhI

Tosoh Bioscience says its Octave BIO multi-column chromatography (MCC) system combined with its SkillPak BIO prepacked columns allows customers to efficiently develop preclinical processes. Tosoh showcased the downstream chromatography offering at BioProduction, part of CPhI Frankfurt, this week. “[The Octave Bio system] that we just launched is unique because it can run any type of chromatography processes such as MCC, SMB, intensified batch,” said Romain Dabre, senior manager, Global Product Management, at Tosoh Bioscience. “And you can even do your…