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Q-Sera, an internationally recognized biotech innovator engaged Bora\u2019s team to develop and manufacture an innovative active protein, RAPClot\u2122 (ecarin), a key component of its proprietary coating to improve the function of a serum-based blood testing device. Blood collection tubes are coated with RAPClot\u2122 formulation, resulting in tubes which rapidly produce high quality serum form samples, including those containing anti-coagulants (which current serum tubes cannot do). RAPClot\u2122 tubes have been designed to replace currently used biochemistry tubes with benefits that may translate into cost efficiencies and reductions for healthcare systems and improved outcomes for patients worldwide.<\/p>\n\n\n\n
Found in some snake venoms, a recombinant version of ecarin is being developed by Q-Sera and Bora from mammalian cell lines. Adding to the project\u2019s complexity, the protein is expressed initially as a larger protein which after cleavage (activation step) becomes the active protein.<\/p>\n\n\n\n
Internally developed from a commercial cell line production clone, the enzyme yield was too low to make it a commercially viable alternative to currently available biochemistry tubes. The novel enzyme-coated blood collection tube has to compete on unit price and production cost with devices currently coated with silicon and other substances.<\/p>\n\n\n\n
However, the distinct advantages of the enzyme-based coating were too compelling to ignore and prompted the innovator to seek the support of an external contract development and manufacturing organization (CDMO) to increase the production yield of high purity RAPClot\u2122. Their search for a strategic partner to develop the potential and productivity profile of RAPClot\u2122 led to a collaboration with Bora\u2019s cell line team and its offer of expert early-stage cell line development (CLD) support.<\/p>\n\n\n\n
To open a new door of development and commercial potential, Bora\u2019s cell line services provided a proof-of-concept study using its proprietary CHO cell lines that allowed the customer to evaluate Bora\u2019s experience with enzyme-based organic chemistries, processing technologies, and manufacturing capabilities.<\/p>\n\n\n\n
The proof-of-concept demonstrated that Bora\u2019s very early CLD platform data (cell pools performance\/data) was greater than the productivity profile of the customer\u2019s original clone. Our team then used that expertise to select the highest-performing clone In light of Bora\u2019s previous and successful experience on enzyme projects, the path to success for this active enzyme technology had already been well established.<\/p>\n\n\n\n
Given the robust data from its CLD platform and past experience, Bora Biologics technical team knew it could expect about<\/span> a <\/span>5<\/span>X yield<\/span> improvement based on that cell pool\u2019s productivity profile. To Q-Sera, it quickly became evident that Bora was an obvious choice to complete both the cell line and cell culture development work.<\/p>\n\n\n\n To express the enzyme efficiently and achieve productivity goals, Bora Biologics\u2019 proprietary CLD platform based on CHO cells provided the foundation to optimize the production process to increase the yield of this particular molecule. Leveraging platform methods, Bora Biologic\u2019s technical team tailored CLD and cell culture process to attain a more stable and efficient process and enhance the yield and quality of this molecule.<\/p>\n\n\n\n The productivity improvement was quite evident at 5X improvement: To improve downstream processes and efficiency, the Bora Biologics team then:<\/p>\n\n\n\n <\/p>\n\n\n\n The value-add for this customer came from Bora Biologic\u2019s experience in dealing with complex molecules as well as expertise in identifying and selecting the highest-performing clones.<\/p>\n\n\n\n Michael Grant, CEO of Q-Sera, says, \u201cCommencing with the Partnering program for promising technologies and initial collaboration, Q-Sera subsequently engaged Bora Biologics to develop its RAPClot\u2122 protein to the current completion of the downstream step. We have been impressed with Bora\u2019s initiative, innovation and commitment to the project.\u201d<\/p>\n\n\n\n Biotech innovation, as well as viable therapeutic molecules, are coming from all corners of the planet. Uncovering a molecule\u2019s true therapeutic potential and patient value is central to contemporary drug strategies, not to mention the strategic alliances necessary to get drugs to patients faster. Based on the function\/format of the molecule and decades-long experience with similar functions and formats of these kinds of drug substances, Bora Biologic\u2019s technical teams can quickly tailor the cell line\/cell culture process to accelerate product potential, meet market demands and timelines and reach patients faster. Cell line development insight boosts active protein productivity more than five times Q-Sera, an internationally recognized biotech innovator engaged Bora\u2019s team to develop and manufacture an innovative active protein, RAPClot\u2122 (ecarin), a key component of its proprietary coating to improve the function of a serum-based blood testing device. Blood collection tubes are coated with […]<\/p>\n","protected":false},"author":2,"featured_media":248059,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[6,8],"class_list":["post-248065","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-biologics","tag-cdmo"],"aioseo_notices":[],"acf":[],"_links":{"self":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/248065","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/comments?post=248065"}],"version-history":[{"count":1,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/248065\/revisions"}],"predecessor-version":[{"id":987499124,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/248065\/revisions\/987499124"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/media\/248059"}],"wp:attachment":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/media?parent=248065"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/categories?post=248065"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/tags?post=248065"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}A tailor-made solution emerges to meet an aggressive drug strategy<\/h2>\n\n\n\n
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Collaborations with better outcomes: Bora Biologics<\/h2>\n\n\n\n
<\/p>\n","protected":false},"excerpt":{"rendered":"