Unwanted immunogenicity to biotherapeutics is a complex and multifactorial challenge. When developing any protein product, it is a potential problem that must be addressed. Unwanted immune responses that target your drug can lead to neutralization and subsequent therapy failure, or worse-still are cross-reactive to essential endogenous proteins, leading to fatal consequences.
Detailed characterization of your product and understanding the level of risk of immunogenicity is not a simple process. You need to deploy the best science, the most rigorous assays and the broadest experience to make the right choices.
We work with clients who are at a range of developmental stages. Our tools are deployed by some as part of their Lead Selection strategy, whereas others may have a final product and want to compare it to a competitor product against the same target or biosimilar. Some clients perform these assays as a routine element of their bioanalysis repertoire during product development; others may need answers to address specific questions that regulatory authorities have posed. ProImmune provides a suite of services for understanding immune responses that can be used together as part of your immunogenicity risk management programme, or as stand-alone assays.
Over the past two decades ProImmune has established a proven track record in working with every type of client organization, across all major disease areas and with all significant classes of test entity.
Virtual, small, medium and large biotech
National health institutes
Novel protein scaffolds
RNA and DNA therapies
Food and crop proteins
Enzyme replacement therapies
Blood factor proteins
Viral gene therapies
Viral vector vaccines
Assessment of novel delivery systems:
Validation of rational design
Clinical trial evaluation through phase III
Manufacturing / CMC
Many of our customer’s studies have been published or presented at conferences including our own Mastering Immunity Conference Series.
Our assay suite covers all main elements of adaptive and innate immune responses, with specialist assays available to deconvolute the involvement of T cells, B cells and antigen presenting cells. Depending on the project requirement our assay services can be deployed alone or in combination depending on the specific project needs.
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