cGMP ADCC/CDC⁺ Antibody Manufacturing

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cGMP ADCC/CDC⁺ Antibody Manufacturing

With our globally recognized cGMP manufacturing facilities and team of experienced scientists, Creative Biolabs is able to provide proper solution to any of your ADCC/CDC enhanced cGMP manufacturing needs. Our proprietary CHO stable cell line platform allows us to provide high yield, traceable and consistent GMP proteins in various lot sizes for clinical applications. Every step of our manufacturing process is in accordance with global standard quality control guidelines.

Our Expertise

State-of-the-art equipments
Establishment and validation on QC
Ideal for preclinical and early clinical trials
Customized design for every step in the manufacturing process

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.

2-7-cGMP-ADCC-CDC-Antibody-Manufacturing-1.png State-of-the-art Equipment
  • Isolation: using incubator inoculated from the master cell bank
  • Sartorius Biostat® STRplus for large-scale production
  • Sartorius Biostat® RM20 and RM50 for seeding
  • Sartorius FlexAct® control system for media preparation, cell harvesting and virus removal
  • GE Healthcare ÄKTApilot chromatography system for protein purification
  • Sartorius Sartoflow®Advanced for ultrafiltration and percolation
  • Colanar semi-automatic filling machine for product formulation

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:

  • Identity
  • Purity/impurity
  • Effective
  • Vitality
  • Tumorgenicity
  • Biocompatibility testing
  • Cell origin
  • Proliferation/differentiation ability
  • Ability to initiate an immune response
  • Cellular level of operation
  • Sterility test (during release phase)

Process from cell line development to production under GMP regulations:

Creative Biolabs
Your R&D Phase
Upgrade
Commercial Phase

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Development of GMP-compliant production cell line
Your R&D Phase
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:

2-7-cGMP-ADCC-CDC-Antibody-Manufacturing-2.pngGMP Facilities
  • Advanced GMP-certification facility
  • Fully compliance on cGMP guidance
  • One-stop, full spectrum service provider that is able to deliver robust and efficient results
  • Final products being provided at various manufacturing scale
  • Adapt the most up-to-date technological improvements
  • Tailored production to your needs
  • Integrated sample fill
  • 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.

RESOURCES

Creative Biolabs provides luciferase-based ADCC assay. This Jurkat cell based assay is pioneered by Creative Biolabs, and the methodology is very well accepted by the field. See attached ADCC Reporter Assay Protocol for further details. 

All products and services are for Research Use Only. Do Not use in humans.

CASE STUDY

ADCC Assay WT vs AfucoTM Mabs  Visit

Resource

Antibody Fc Engineering: Towards Better Therapeutics  Visit

ONLINE INQUIRY

Creative Biolabs has established a team of customer support scientists ready to discuss ADCC/CDC optimization strategies, antibody production, bioinformatics analysis and other molecular biology/biotechnology issues.

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