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Press Release

Creative Biolabs Released a Comprehensive ADC Manufacturing Service

Creative Biolabs
Posted on: 03 Jan 18

As a biopharmaceutical company highly specialized in advanced antibody biochemistry and engineering, Creative Biolabs recently has launched a comprehensive ADC manufacturing service based on manufacturing platforms and pipelines.

 

 

Comprised of a monoclonal antibody, highly toxic payload drugs and a small molecular linker,  an antibody-drug conjugate (ADC) is considered as a new generation of highly hazardous and toxic pharmaceutical products formed by covalent biochemical conjugation.

 

As a multistep process that requires proper facilities that strictly follow the criteria and guidelines of cGMP-standard bio-macromolecule production, ADC manufacturing can be divided into three distinct stages: cGMP production of the antibody, cGMP synthesis of the drug-linker complex, and conjugation to form an ADC.

 

“Our cGMP antibody drug conjugate manufacturing service platform has the capacity of pilot (5~35 L) to large scale (> 100 L) preparation of therapeutic antibodies or recombinant proteins using various expression systems. We also offer process development services under this platform to help establish cGMP stable cell lines, cell banking, upstream process optimization, and downstream scale-up. ” A scientist from Creative Biolabs said that.

 

“We also provide customized chemical synthesis service and fine chemicals based on our well-established organic synthesis chemistry pipeline in R&D and cGMP environments.  ADC conjugation is achieved in cGMP certified reactors after small-scale conjugation protocol verification. ”

 

Creative Biolabs and their collaborators are also equipped with the state-of-the-art analytical platform (MALS/IR, LC/MS/HPLC, UHPLC, CE, icIEF, UV/VIS, Moisture analysis, CCI…) for ADC characterization and ensure the purity and quality of the end products. Process development services are also available for optimizing conjugation strategy, formulation, purification scheme, and scale-up production of ADC to gram scale.

 

About Creative Biolabs

 

Established in 2004, Creative Biolabs is highly specialized in advanced antibody biochemistry and engineering. With more than a decade of exploration and expansion, our current research and service capacity covers the entire new drug discovery and development pipeline, ranging from early discovery, preclinical evaluations, cGMP manufacturing, to clinical trials. As an international cooperation, we have established offices all around the globe with more than 200 well-trained full-time scientists and technicians, who work closely with our customers and research partners to develop new medicines for a better, healthier world. 

 

Editor's Details

Bella Smith
www.creative-biolabs.com/adc

Last updated on: 03/01/2018

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