State-of-the-art Equipment
All procedures related to CGMP antibody manufacturing should carry in GMP certified facilities. Our
facilities are designed and organized according to Good Manufacturing Practices for Pharmaceutical
Manufacturing. Instructions are given on quality control, quality system methods, and control of the
collection, processing, storage and final release of products.
cGMP Compliant CHO Cell Line
With extensive experience in protein expression and our advanced mammalian cell line engineering
platform, Creative Biolabs offers integrated cGMP-compliant CHO stable cell line manufacturing services,
such as glycoengineered CHO Cell Lines for ADCC antibodies biomanufacturing.
Quality Control
The quality of the starting material significantly affects final performance of protein products, and we
believe the success of a therapeutic antibody development largely depends on quality of the raw
materials. To develop therapeutic antibody products that meet regulatory requirements, Creative Biolabs'
GMP manufacturing team adheres to GMP-compliant procedures to ensure that our tools, reagents, and
accessories for antibody-protein manufacturing comply with guidelines.
Standards used are the European Pharmacopoeia (EurPh) or the United States Pharmacopoeia (USP).
Characteristics of each batch of cell products are controlled by very rigorous and specific tests. Cell
product characterization tests include validations on following attributes:
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Identity
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Purity/impurity
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Effective
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Vitality
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Tumorgenicity
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Biocompatibility testing
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Cell origin
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Proliferation/differentiation ability
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Ability to initiate an immune response
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Cellular level of operation
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Sterility test (during release phase)
Process from cell line development to production under GMP regulations:
Development of GMP-compliant production cell line
Your decision to proceed with GMP manufacturing
One-time license fee payment
Process development & GMP manufacturing
Your product for clinic and market
Benefits & Features
Creative Biolabs specializes in the development, production and delivery of GMP-compliant ADCC/CDC⁺
therapeutic
antibodies. Our assets are:
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Advanced GMP-certification facility
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Fully compliance on cGMP guidance
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One-stop, full spectrum service provider that is able to deliver robust and efficient results
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Final products being provided at various manufacturing scale
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Adapt the most up-to-date technological improvements
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Tailored production to your needs
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Integrated sample fill
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Strong willing to help you advance your biopharmaceutical candidates into clinical development
For more details about our cGMP ADCC/CDC⁺ Antibody Manufacturing service, please do not hesitate to contact us.
