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 for any Biosimilar.
We have validated assays for the assessment of high-profile molecules such as Adalimumab, Pegfilgrastim and Ustekinumab, among others.
Biosimilar Services
MSD Instrument – ECL (Platform)
ELISA (Platform) – Absorbance
Gyrolab
NAB
Overcoming Biosimilar Challenges
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
Improving the quality of human health
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Discuss biomarker and bioanalytical solutions to accelerate your therapeutic pipeline
