$2.5M Contract Awarded to ChromaTan to Develop Continuous Purification Platform
CCTC Process Development System. Credit: ChromaTan
ChromaTan Corporation, a provider of continuous and single-use chromatography solutions for the biotechnology industry, has been awarded a $2.5 Million dollar contract from the Food and Drug Administration (FDA). The project involves the development of an integrated, continuous downstream purification platform for production of monoclonal antibodies. The objective of the project is to drive significant improvements in product quality, as well as to enable more flexible manufacturing facilities and cost-of-goods reductions, for production of life-saving antibody therapies. The two-year project will focus on process development, design, and testing of a multi-unit operation process train that can continuously purify a monoclonal antibody (mAb) harvested from a CHO cell-based bioreactor system at steady state through multiple purification modalities. The bulk of the work on the platform called CCTC™ - Continuous Countercurrent Tangential Chromatography (CCTC) - will be performed at ChromaTan’s new laboratory location in West Philadelphia.
To meet the goals of the 2-year project, ChromaTan expects to be announcing job openings in the areas of R & D management, Process Analytical Technologies (PAT) and Quality Control.
Oleg Shinkazh, ChromaTan’s founder and CEO, stated “We are thrilled to begin execution of this contract. At this time there is no doubt that continuous manufacturing is on its way to becoming a reality in bioprocessing. We believe we have a unique offering in our CCTC platform that will enable manufacturers to transform the way they produce these muchneeded therapies. We also look forward to working with the experienced team at the FDA to provide feedback and guidance on the framework for regulatory compliance of the CCTC platform and for the overall field of continuous bioprocessing.”
ChromaTan, a startup at the Innovation Park bioprocessing space based in State College, PA, developed CCTC as a novel column-free purification technology. Their recent work with major biopharmaceutical companies has demonstrated that CCTC provides significant improvements over conventional batch purification solutions in terms of productivity, product quality, and ease-of-use. The company is funded by individual investors, NIH SBIR grants, Pennsylvania state funds, Ben Franklin Technology Partners of Central PA, and Life Science Greenhouse of Central PA.
ChromaTan is actively engaging with customers on R & D partnerships for beta testing the CCTC platform. The company is also preparing for an equity fundraising round.
ChromaTan will exhibit the beta process development system with partner Purolite at the upcoming BioProcess International Conference in Boston (Sep 25–28) at booth 1323.
This article has been republished from materials provided by ChromaTan. Note: material may have been edited for length and content. For further information, please contact the cited source.
Rapid Removal of Arsenic From Drinking Water...By Moss!News
A moss capable of removing arsenic from contaminated water has been discovered by researchers. And it happens quickly – in just one hour, the arsenic level is so low that the water is no longer harmful for people to drink.READ MORE
Stable Beta-Amyloid Dimers Identified in Alzheimer’s BrainsNews
A recent study exploited state-of-the-art mass spectrometry to provide the first direct evidence of beta-amyloid dimers in patients with Alzheimer’s disease and points to the potential of these molecules as biomarkers. Beta-amyloid dimers may be the smallest pathological species that trigger Alzheimer’s disease.
Protein Target Identified That Could Prevent StrokesNews
Scientists have identified a protein, called GPR68, that senses blood flow and tells small blood vessels called arterioles when to dilate. The researchers believe medications that activate GPR68 could one day be useful to treat medical conditions, including ischemic stroke.READ MORE