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Using analytics and bioassays to de-risk your mRNA LNP drug development programme

Pharmaceutical Technology

Another area where we tend to see problems is in encapsulation efficiency,” says Andrew Kondratowicz, Bioassay Team Lead, Precision NanoSystems. The bioassays are the canary in the coal mine of how well your process development is going. Where is your payload? Where is it allocated?

Bioassay 130
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Cell and Gene Therapy Bioassay – A Prerequisite for the ATMPs Development

Roots Analysis

Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Therefore, increase in development of cell and gene therapy domain has led to the rise in demand of bioassay services for cell and gene therapy. Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance.

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Analytical quality by design: Development of cell-based bioassays

Bio Pharma Dive

Care needs to be taken during analytical development to ensure methodologies firstly, reflect the MoA, and are also reproducible, accurate, and robust.

Bioassay 147
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KBI Biopharma Completes Eurofins DiscoverX Products Specialized Bioassay Certification Program

BioTech 365

& … Continue reading →

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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Carcinogenicity testing For decades, the two-year rodent bioassay has been the regulatory standard used to determine the carcinogenic potential of new drugs. This process historically involved lifetime carcinogenicity bioassays in two species. Figure 1: Comparing Carcinogenicity Testing Timelines in Transgenic vs. Standard Mice.

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Toregem BioPharma and WuXi Biologics to partner for antibody development

Pharmaceutical Technology

As part of the collaboration, Toregem will use WuXi Biologics’ integrated CMC services in cell culture development, cell line development, bioassay development, biologics GMP manufacturing, cell banking and testing services, as well as other related services.

Antibody 130
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Latest eBook – Make the switch to label-free interaction analysis

Drug Discovery World

The latest Creoptix eBook reveals the challenges presented by conventional label-based bioassays and explores how label-free interaction analysis can deliver a world of insight. Conventional bioassays rely on enzyme or fluorescent labels to detect biomolecular interactions.