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Because patents for many of biological drugs worldwide have been or will soon be expired, the billion-dollar biosimilar market promises exciting opportunities but also lies in many challenges. As the FDA finally came up with a draft of guidance on biosimilars in May, 2014 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf) development of highly stable, regulatory-acceptable and highly productive cell lines is probably the most critical challenge in the path of biosimilar development.
AsscentGene has been specialized in developing stable cell lines and early stage of drug development for therapeutic biologics including recombinant proteins, monoclonal antibodies and vaccines. Our clients include National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Development (NICHD), Food and Drug Administration (FDA) and pharmaceutical/biotechnology companies worldwide.
AscentGene is pleased to announce the new release of VLP (Virus Like Particle) Production Services.
VLP Production Services are using our upgraded baculovirus system throught the self-assembly mechanism. Ascentgene has been successfully producing high titer (4×1013vlps/ml), high quality (>99% pure), and high activity VLPs with ultra yield (2 x 1014vlps/L culture) by using either CsCl gradient or chromatography protocols.
AscentGene, Inc., a leading biotechnology company specialized in cell line development and services, has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) Laboratory of Molecular Biology (LMB) for the production of anti-CD25 immunotoxins in AscentGene’s proprietary AG-CHO™ cells. By using AscentGene’s cell lines to produce this immunotoxin, we will obtain improvement in purification and yield of the immunotoxin protein from LMB’s current method of protein production.
The immunotoxins produced by LMB at the NCI are typically composed of an antibody variable fragment (Fv) directed against a cancer target that is fused to a truncated Pseudomonas exotoxin A (PE38). LMB lead by Dr. Ira Pastan, an NIH distinguished investigator and Dr. David Fitzgerald, has been producing numerous immunotoxins for the treatment of cancers. All these immunotoxins, however, must be produced in E. coli as insoluble proteins and subsequently purified and renatured, a procedure that is expensive and laborious. The optimization of the purification steps for producing these proteins is the goal of this CRADA.
AscentGene will use its proprietary AG-CHO™ cell line to produce the anti-CD25 immunotoxins. Because of the mutations of AG-CHO™, the cell line is protected from toxin-induced cell death and able to produce and secrete active immunotoxins into medium. Under this approach, the steps to renature the protein or remove endotoxins are eliminated, making purification easier and less costly, as well as improving protein yields and activity. The LMB will use these immunotoxins in testing their activities in cell lines and animal models. The results of this CRADA will aid the LMB in defining the therapeutic application of its immunotoxins, possibly paving the way for newer and more efficient eradication of targeted cells.
About AscentGene, Inc.
Possessing innovative technologies and a high competitive team of scientists, AscentGene provides products and services in unparalleled qualities. AscentGene’s cell line service is perfect for expressing engineered antibodies, proteins, and enzymes for research, drug development, and other medical applications. Using highly expressive vectors and innovative selection methods, AscentGene can insure a working stable cell line in the shortest time possible. AscentGene also provides a complete cycle protein services, ranging from subcloning and protein expression to protein purification and protein assays.
The Royal Swedish Academy of Sciences today decided to award the Nobel Prize in Chemistry for 2012 to Robert J. Lefkowitz and Brian K. Kobilka for their work on G-protein-coupled receptors. Continue reading