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GMP-Creative Biolabs, One-stop, Full cGMP Service, Fasten Your Process to Cinical and Market

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USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-871-5806
Fax: 1-631-207-8356
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Process Validation

Process Validation

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 compliant to 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 a 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 by