Assurance of Clonality for Existing Cell Lines
Proving Your Master Cell Bank (mono)clonality to Regulators.
Proving Clonality for Regulatory Compliance
Ensuring your Master Cell Bank (MCB) is monoclonal is crucial for regulatory approval when registering a biologic. Regulatory agencies (such as FDA and EMA) demand proof that your MCB originates from a single progenitor cell. This is a fundamental expectation, as outlined in the ICH Q5D guideline.
Understanding the Client Problem
Our Proven Solution
We offer an analytical approach to demonstrate the clonality of your existing MCB, providing the evidence needed for regulatory compliance without the need for re-cloning.
Proving Clonality for Regulatory Compliance
Ensuring your Master Cell Bank (MCB) is monoclonal is crucial for regulatory approval when registering a biologic. Regulatory agencies (such as FDA and EMA) demand proof that your MCB originates from a single progenitor cell. This is a fundamental expectation, as outlined in the ICH Q5D guideline.
Understanding the Client Problem
Many older, legacy cell lines, created using older approaches (e.g. limiting dilution), do not meet current stringent regulatory standards for clonality. Updating the MCB can be a lengthy and complex process, which involves significant time and effort to demonstrate equivalence to regulators.
Our Proven Solution
We offer an analytical approach to demonstrate the clonality of your existing MCB, providing the evidence needed for regulatory compliance without the need for re-cloning.
HOW WE CAN HELP
By partnering with us, you can confidently prove the clonality of your existing cell lines, ensuring regulatory approval and maintaining the integrity of your biologic products.
- Regulatory Compliance: Meet stringent FDA and EMA requirements with our proven methods.
- Efficiency: Avoid the lengthy process of re-cloning and demonstrating equivalence
- Reliability: Enhance the overall integrity and reliability of your biologics manufacturing processes.
- Expertise: Leverage our advanced technologies and expertise to ensure the highest standards of clonal assurance.