New York, USA – September 29, 2020 – This century witnessed various kinds of antibody engineering techniques being actively developed. These innovations have accelerated the development of therapeutic antibodies. A series of therapeutic antibodies have been launched and are now being used in clinic, which shows great potential not only in the treatment of cancer.
Based on the extensive regulatory experience of more than 15 years as well as rich laboratory capacity, Creative Biolabs now offers global clients with therapeutic antibody and protein platforms covering antibody discovery, engineering, production, structural and biochemical characterization, bioassays, in vivo animal testing, manufacture and development, IND regulatory services.
During all the phases, development plays a vital role in building the bridge from discovery to manufacture for economic competitiveness. Creative Biolabs has successfully established a broad range of development and manufacture platforms for various immunotherapies including therapeutic monoclonal antibody, bispecific antibody, antibody drug conjugate, other therapeutic protein products, cellular therapy, etc.
• Cell Line Characterization
Cell line characterization is a key step in ensuring the safety of biopharmaceutical products with the aim of confirming the identity, purity, genetic stability and tumorigenicity of cell lines. This characterization can ensure that the source of the cell line is authentic and free from contamination, undesirable cells and foreign factors.
Creative Biolabs has extensive experience in the cell bank characterization for biopharmaceutical and vaccine production and offers a wide range of services to characterize cell banks, develop and design scientifically-validated and proven cell line characterization testing methods. Cell line characterization tests include Eukaryotic cell line characterization, such as identity testing, RAPD assays, sterility testing, and Prokaryotic cell line characterization, such as gram stain, antibiotic resistance test, purity test.
• Viral Clearance Studies
Viral clearance is a key step in the development process of antibodies, proteins, tissue and blood-derived products. The contamination is mainly from the use of cell lines, tissue sources or raw materials of animal origin.
Creative Biolabs now provides a comprehensive, fully cGMP-compliant virus clearance services for Adenovirus, Retrovirus, Parvovirus, Pseudorabies virus, influenza virus, etc, covering all stages of the development, manufacture and release of biological products. The professional virus clearance team has conducted thousands of tests for biopharmaceutical customers, all of which have been fully validated and followed ICH Q2 requirements.
“Our viral clearance services cover virus inactivation and virus removal. For example, for virus removal, our team will apply various methods including chromatography, affinity, Ion exchange, hydrophobic, gel filtration and nanofiltration,” introduced by a senior scientist at Creative Biolabs.
In addition to these services, Creative Biolabs’ integrated development services also include cell line development, cell banking, cell culture process development, purification development, formulation development, analytical and bioassay quality control, etc.
More information can be found on https://www.creative-biolabs.com/immuno-oncology.
About Creative Biolabs
With great passion for the new chapter of cancer treatment, Creative Biolabs believes that next-generation immunotherapy will provide the best opportunity to discover and advance the drug pipeline for global partners. The expert team now introduces the first-class therapeutic antibody and protein platforms to guide clients through challenges from target selection to IND regulatory support.