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Process Development

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Process Validation

Creative Biolabs

With our excellent history in satisfying regulatory authorities and reproducibly producing safe and efficacious therapeutic antibodies and proteins, Creative Biolabs provides a full package of custom services on designing and executing appropriate process validations, strictly in compliance with cGMP guidelines.

Our custom Process Validation service package includes, but is not limited to:

Technology transfer from process development to pilot or full-scale manufacturing

Process studies and designs to create a robust licensure package

Cleaning validation

Validation of filter reuse

Viral clearance validations/evaluations/certifications

Scale down and process-scale validation at selective or all steps

Extensive validation documentation, such as master validation plans, validation plans, and validation reports.

Process analytic technology (PAT)

Validations begin with good process development, Creative Biolabs also provides a full line of services on process development. For more information, please visit “Process Development”.

To discuss your Process Validation demands or to request a proposal, please contact us.

For Research Use Only. Not For Clinical Use.

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