Take advantage of our fully managed biosimilar development services to ensure traceability and comparability throughout all development stages.
With you on your biologics journey...
Why biosimilar development?
The aim is to develop a production process, including analytical methods, for the target biosimilar molecule that optimizes the yield, cost, robustness, comparability, operability, and scalability according to cGMP guidelines.
3P biosimilar development services
Analytical methods are developed according to their intended purpose (identity, impurity, assay or other) in supporting IPC, release and/or stability testing. Analytics are designed based on the principles defined in ICH Q6B guidelines, with qualification activities following ICH Q2 guidelines.
Quality Target Product Profile (qTPP)
We use the Quality Target Product Profile (qTPP) step to evaluate how the innovator varies from batch to batch while identifying Critical Quality Attributes (CQA). Data generated during this evaluation is used throughout the biosimilar development activities. Once the quality attributes and variability of the innovator molecules are known, analytical testing can be defined.
During process development, we test biological activity, purity, and other relevant quality attributes to assure the quality of the candidate. Demonstration batches are performed to show process robustness and generate protein used for reference material preparation, formulation, and initial stability studies.
The formulation of the biosimilar does not necessarily have to be the same as the originator molecule. However, the guidelines recommend justifying any differences in excipients or composition. Therefore, we aim to formulate the biosimilar using the same composition as the originator molecule to avoid this complexity while seeking to prevent any potential impact on product stability or clinical results. Formulation studies are carried out under the EMA CHMP/QWP/396951/2006 guidelines and will use excipients (and/or other reagents) described in the relevant Pharmacopoeia.
What we will deliver
We deliver a fully managed biosimilar development service, ensuring that traceability and comparability are demonstrated throughout all development stages.