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Webinar | Challenges of developing ADA and concentration (PK or PD) assays for lysosomal transgene enzymes

博客 - One of the biggest challenges faced by the bioanalytical sector is the lack of a true reference material. As a result, in most assays, an alternative commercially available therapeutic (for example, an enzyme replacement therapy (ERT) product) can be used as a surrogate for the transgene enzyme. This webinar discusses approaches taken in order to monitor the concentration of the expressed transgene product and any associated immunogenicity.

How To Build a Comprehensive Response to Client Needs as a CRO

博客 - As a CRO, meeting client expectations can be an ongoing challenge. What can organisations do to make sure their research is as effective and efficient as possible? In the Autumn 2022 issue of European Pharmaceutical Contractor magazine, the leadership team from Alliance Pharma reviews what CRO organisations can do to make sure their research is as effective and efficient as possible while meeting the ongoing challenge of their customer's expectations.

Challenges of developing an ADA assay for bispecific antibody therapeutics and ADA characterisation

博客 - Bispecifics (Bs) are biopharmaceutical products that bind to two different targets (epitopes). These are mainly two types: IgG-like (antibodies Abs) and non-IgG-like which include Bites (bispecific T-cell engager) and DARTs (Dual-affinity Re-targeting Antibody).

Development and validation of an immunogenicity assay for detection of anti-AAV antibodies

博客 - Adeno-associated viruses (AAV) are small viruses that infect humans and some other primate species. The AAV is transformed from a naturally occurring virus into a delivery mechanism for gene therapy.

A method to measure anti-vaccine antibodies

博客 - An antibody assay was required to detect and quantify IgGs produced against a vaccine. This was required to measure the efficacy and reliability of the vaccine.