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

Blog - 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.

10 February 2023
How To Build a Comprehensive Response to Client Needs as a CRO

Blog - 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.

27 January 2023
Challenges of developing an ADA assay for bispecific antibody therapeutics and ADA characterisation

Blog - 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).

01 January 2023
Development and validation of an immunogenicity assay for detection of anti-AAV antibodies

Blog - 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.

01 January 2023
A method to measure anti-vaccine antibodies

Blog - 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.

01 January 2023
AMS Sandwich Celebrates 10th Anniversary

Blog - Analytical and Materials Science (AMS) Sandwich Team recently celebrated their 10th Anniversary in an event marking Discovery Park’s 10th Anniversary. AMS Sandwich was founded in 2012 at Discovery Park – Kent’s largest science and innovation park situated just outside of the historic town of Sandwich. The team, initially comprising a few members, was formed with the aim of plugging a gap identified in the ‘Materials Science’ area of pharmaceutical development.

05 December 2022
The next chapter in Nitrosamine Testing

Blog - Based on industry feedback following the recent requirements regarding risk assessments of marketed products, a significant amount of small molecule related APIs, possibly 30%+, have been shown to have the potential to form active related nitrosamines

01 December 2022
Presentation Slides - The Importance of Good Experimental Design for Extractable and Leachable Studies

Blog - AMS Science Lead Mike Ludlow explains the importance of good experimental design for extractable and leachable studies.

10 November 2022
A step-by-step guide to developing a robust assay in bioanalysis using LC-MS/MS

Blog - Read our guide ‘A step-by-step guide to developing a robust assay in bioanalysis using LC-MS/MS’ to learn about our proven approach to developing industry-leading LC-MS/MS bioassays.

22 September 2022
CRO Alliance Pharma’s Executive Team Grows by Four, Supporting Bioanalytical and CMC Testing Expansions

News - Alliance Pharma (Alliance), a global leader in bioanalytical, DMPK and CMC testing services in the pharmaceutical and biopharmaceutical industry, has grown their leadership team by four, bringing onboard a new Chief Operating Officer (COO), Chief Commercial Officer (CCO), Chief Financial Officer (CFO), and Chief People Officer (CPO). These leaders will support continued global expansion, which includes Alliance’s recent acquisition of U.K.-based Drug Development Solutions (DDS) from LGC and new bioanalytical laboratory opening in Australia in November.

21 September 2022