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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…

Less is More in mRNA Therapeutics: Developing Big Ideas in Small Scale

This webcast features: Linda Mathiasson, Strategic Customer Lead, Cytiva. Messenger RNA technology has changed the way therapies are developed. The overall potential of mRNA is clear, with mRNA therapeutics being developed in many research areas. The speed and potential cost gains of mRNA technology make it an interesting technology for personalized medicine. However, much of the current equipment used in manufacturing is repurposed from the biotech industry and is designed for much larger scales than needed for mRNA. In this…

Resource Roadmap to Screening Success: Cell-based Therapy Edition

Due to the tight link between cell culture conditions and final product quality attributes, thorough evaluation of raw materials and process parameters is critical to the development of cell-based therapies. Screening a wide array of process inputs using conventional methods and variable reagents can be costly and time consuming. This Resource Roadmap illustrates the use of the Sartorius Screening Ensemble to enable broad exploration early in development while also accelerating experimental design, execution, and validation Read this Resource Roadmap to…

Small Format Connections for Optimizing Manufacturing

This webcast features: Ray Rendon, Application Development Manager, Colder Products Company. Application Development Manager, Ray Rendon, examines areas for improvement in small format manufacturing processes that are commonly used in cell and gene therapies, sampling, or other small format manufacturing. Optimization of these processes can be achieved with tube welding alternatives like single-use aseptic connectors. In this webinar, you will learn: Key considerations when reviewing your existing processes, such as the total cost of ownership of tube welded connections and…

Optimize Your Early Preclinical Process for Gene Therapy Success

Early decisions can impact the success of a novel gene therapy, so how can therapeutics companies make sure to set off on the right track? In this article, drug developers will learn some things that they should consider at the start of their therapeutic journey. We explore the impact of early technical decisions, including the importance of seeking high-yielding plasmids and a well-validated cell line. We cover logistical considerations, such as plasmid supply chain challenges and how to avoid them.…

Effective Processing of Lentiviral Vectors: Introducing a Paradigm-Shifting Technology

Therapeutic developers face significant challenges in purifying cell and gene therapies (CGTs). Current technologies for laboratory-scale lentivirus (LV) feedstock preparation are inefficient and not fit for purpose. From the benchtop to the clinic, all stages of CGT development require new solutions that break away from the current paradigm of biopharmaceutical manufacturing. Nereus LentiHERO nanofiber-based technology can address difficulties associated with purifying large and fragile modalities. Here, experts from the viral vector team at Astrea Bioseparations discuss how Nereus LentiHERO technology…

Advanced Liquid Transfer with Single-Use Systems

Most biopharmaceuticals are manufactured in large-scale stainless-steel piping and vessels, with downstream processes taking place within rigid and inflexible facilities. Although process steps such as harvest, purification, fermentation, filtration, dispensing, and freezing require flexibility, stainless steel has not been replaced yet by single-use systems at a large scale. However, manufacturers wanting to optimize process efficiency and scalability to obtain a viable and valuable product for commercial use inevitably will need single-use technology. Aseptic fluid management with single-use systems offers numerous…

Recombinant Protein Expression with a Baculovirus–Insect Cell System

Proteins create cellular matrices, catalyze biochemical reactions, and form signaling pathways to respond to external stimuli. Studies of protein structure and function increase researchers’ understanding about the foundations of life. However, because most proteins are difcult to obtain commercially, it is important to establish sources that can provide researchers with plentiful supplies of proteins. In recombinant protein expression, a gene encoding a protein of interest is cloned into an expression vector (usually a plasmid) and transferred into a host cell…

Overcoming the Productivity Bottleneck in MAb Capture

It is no secret that progress toward intensifying monoclonal antibody (MAb) production processes has focused on upstream steps. Although the industry welcomed increased production, that also created bottlenecks in downstream processing, including during capture chromatography steps. Technologies that are intended to alleviate such bottlenecks must meet four important criteria to increase productivity and profitability. They must • improve productivity of the MAb capture process, such as by purifying more MAbs, using less media, and/or reducing timelines. • perform as well…