Biosimilar Bioanalytical Services for Development
Bespoke and validated biosimilar bioanalytical services designed to support and accelerate biosimilar development.
Expert Biosimilar Development and Assay Solutions
At Synexa, we specialise in biosimilar development services, including the design and validation of assays tailored to each customer’s specific requirements.
Our expertise includes validated assays for high-profile biologics such as Adalimumab, Pegfilgrastim and Ustekinumab, supporting robust and reliable data generation across development programmes.
Biosimilar Bioanalytical Services
MSD Instrument – ECL (Platform)
ELISA (Platform) – Absorbance
Gyrolab
NAB
Overcoming Biosimilar Development Challenges
Biosimilar development presents unique scientific and regulatory challenges. Synexa supports customers in navigating these complexities with tailored, high-quality solutions. Key challenges we address include:
- Demonstrating equivalence across multiple attributes, requiring highly sensitive and validated analytical assays
- Managing variability in biologics across instruments, reagents, operators and conditions
- Conducting robust bioequivalence studies and immunogenicity assessments
Aligning with evolving regulatory requirements to ensure safety, efficacy and comparability
Our collaborative approach ensures each biosimilar programme is supported with precision, flexibility and scientific expertise.
More on Biosimilars
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GMP Grade Ligand Binding and Potency Assays – Frequently Asked Questions
Establishing Biosimilarity: Regulatory and Scientific Expectations
Improving the quality of human health
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