Cell and gene therapy (CGT) is one of the most promising and faster growing sectors in biopharmaceutical industry. With the increasing popularity of gene editing and reprogramming of human cells, it is crucial to understand and recognise the differences between steps involved in process development (PD) and commercial manufacturing. The clinical manufacture of a CGT product is governed by stricter requirements vs PD and regulations as per Good Manufacturing Practices (GMP). However, as the cell line development (CLD) technologies continue to rapidly evolve, GMP regulations need to adopt accordingly to meet the demand and reflect the clinical risk profile of these innovate solutions.
Importantly, the transfer of practises from PD to GMP-friendly settings can pose several challenges, which with the right planning can be easily avoided. A detailed analysis of the CLD workflow from single cell seeding, through the use of clinical grade reagents to risk and data management, can be extremely helpful in establishing a GMP-compliant manufacturing process early on.
During this session we will discuss the following the key considerations for manufacturing of CGT including:
The trend in Cell Line Development (CLD) is to screen and select clones earlier and with more confidence. At the fed batch stage of the CLD process, particularly in DW 96, 48 and 24 well plates, limited sample availability precludes some measurements from being taken (VCD and titer for example). The low speed of currently available cell counting technologies means that the time taken to analyse, outweighs the benefit of the data. In this talk we introduce the ICON analyser which rapidly measures small volume samples for titer and VCD and combines with confluence and clonality results within the STUDIUS data management platform to make secure, early decisions on best performing clones. Also, we will discuss how our InstiSHAKE supplements for the shaking cell culture and fed-batch stage, improve the outcomes for cell lines to ensure all candidates are considered in the search for best performers.
Cell Metric is a high contrast imager designed for single cell imaging, identification and clonal outgrowth characterization.
Cell Metric captures and records crucial evidence, whole well image of the single cell at day 0 and daily imaging thereafter, all wrapped up in a clonality report defining best practice for Master Cell Bank production.
Available as a stand-alone single plate system, or with automated plate handling within a temperature-controlled environment from Cell Metric CLD or downstream third-party robotic integration.
Designed to meet the high sample throughput, regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs, the OsmoTECH PRO Multi-Sample Micro-Osmometer combines ease-of-use with accurate and precise osmolality measurements for reliable and reproducible results.
Optimize and ensure the quality and consistency of buffers, media, product, excipients, and process parameters to maximize biologic yield, quality, and purity.
The OsmoTECH XT measures the widest variety of sample types (high concentration, high viscosity) accurately across bioprocessing and cell & gene therapy workflows.
It’s also designed to make your work as streamlined and comfortable as possible with even more robust data integrity and compliance features to match your digital environment.