Biosimilars

Bespoke and validated platforms to progress Biosimilar development.

Harness Synexa's Deep Biosimilar Expertise

At Synexa, we specialise in the development and validation of assays according to a customer’s priorities and requirements on any Biosimilar.

We have validated assays for the assessments of high-profile molecules such as Adalimumab, Pegfilgrastim and Ustekinumab among others.

Our lab has supported numerous successful biosimilar programs, collaborating closely with customers to navigate the following challenges accordingly:

Biosimilars must demonstrate equivalence across various attributes and lots, demanding specialised assays and validation
Biologics’ inherent variability calls for nuanced analytical approaches, accommodating differences across instruments, reagents, operators and conditions
We recognise the complexity of each biosimilar project and offer tailored solutions that encompass bioequivalence studies, anti-drug antibody (ADA) assessments and more
The regulatory landscape around biosimilar development has numerous complexities, requiring meticulous alignment with evolving standards and rigorous comparative analyses to ensure safety, efficacy, and biocompatibility

The Scientific Partner of Choice for Biomarker and Bioanalytical Solutions

Bridging the gap between science and life.