ADC Fill and Finish

To simplify Antibody-drug Conjugate (ADC) discovery and development, Creative Biolabs offers a series of ADC services including ADC antibody screening, conjugation chemistry, linker and payload service, analytical characterization and validation, fill and finish and other antibody relevant services to help our clients gain a promising ADC candidate. We are fully competent and dedicated to being your reliable partner for ADC fill and finish service.

ADC Fill and Finish Services

We offer fully automated final ADC drug product formulation and filling in compliance with cGMP regulations as defined by the worldwide regulatory agencies, such as US FDA, EMA, NMPA, CFDA and agencies from other countries or regions such as Japan, Taiwan, Korea, Singapore, Israel, Australia and India, etc.

• Liquid formulation and fill;
• Lyophilization formulation and fill;
• Both biologics and aqueous non-antibiotic and non-cytotoxic small molecule parentally;
• Dedicated formulation and filling facility for ADC drugs or other highly-potent drug products;
• Multiple validated container and closure configurations (ranging from 2 mL to 50 mL).

ADC Formulation Development

We also offer a full range of ADC formulation development services include:

• Liquid formulation development (heat stress study, agitation study, freeze-thaw study);
• Lyophilization cycle development (heat stress study);
• Container closure selection (accelerated stability, long-term stability).

ADC Manufacturing

We offer advanced ADC manufacturing platform and pipelines which are fully designated for large scale ADC manufacturing including:

• cGMP antibody manufacturing;
• cGMP payload drug and linker synthesis;
• cGMP chemistry conjugation, purification and filling.

Others

In addition, Creative Biolabs also offers ADC process development services to optimize conjugation strategy, purification scheme, formulation and scale-up production of ADC to high yields.

Highlights

• Advanced facilities strictly follow the criteria and regulations of cGMP-standard biologics production;
• Operated under an occupational exposure limit (OEL) below 50 ng/m³;
• Fully designated for large scale ADC manufacturing;
• Flexible small-scale sterile filling.

With senior Ph.D. level scientists and extensive experience in the field of ADC discovery and development, Creative Biolabs now offers ADC manufacturing, formulation development, fill and finish services to facilitate your ADC program and push the progress forward. For more detailed information, please feel free to contact us.

For Research Use Only | Not For Clinical Use

Resources

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