Manufacturing of biopharmaceuticals is subjected to many changes, such as rising volume demands by meeting more stringent safety requirements. These prevailing conditions challenging conventional manufacturing platforms to re-think and re-innovate, which have not adapted sufficiently to address these changes at low cost. Oncosmis' (AcceTT® and BacSec®) technology is designed to meet these demands while keeping the yield of biologic drug at a much higher level compared to current competitors. AcceTT® and BacSec® have established platform technologies at lab scale and would ideally be suited for the development and large-scale manufacturing of a wide range of biologic drugs in both CHO cells and E. coli.
AcceTT®: This technology facilitates rapid and high yield production of biologics couple with robust cell growth. AcceTT® is a fully integrated technology platform that comprise of vectors, media toolbox and cell line to establish ultra high producing cells in short period of time.
AcceTT® for mAb stoichiometry and higher yield: To address synchronized higher subunit expression and secretion of mAbs, a new regulator element has been introduced to match stoichiometry of both light and heavy chains of mAb. (P+ = addition new regulatory element).
BacSec® technology for toxin-free production of biologics: BacSec® technology is a fully integrated platform comprises of plasmid, bacteria and media formulation for secretion of proteins into media without disintegration of Bacteria.
BacSec® technology: BacSec® technology not only provides a tool to circumvent toxicity and other contamination issues but also simply the downstream process for production of therapeutic proteins in E. coli.
A) Graph represents typical pattern to detect total antibodies against SARS-CoV-2 virus in plasma. In first step, biosensor shall be hydrated in PBS. In second step, after hydration the biosensor shall be dipped into His-tagged Antigen for immobilising on the tip of the biosensor. In third step, after antigen binding, the biosensor shall be washed in PBS to remove excess unbound protein or loosely bounded antigen. In fourth step, after washing of ligand bound biosensor shall dipped into plasma or blood samples. Acquiring data of interference pattern of white light by biosensor in real-time during steps 1, 2, 3 and 4.
B) Binding curve represents plasma samples collected from patients which are diagnosed with RT-PCR (+Ve) and RT-PCR (-Ve). No antigen control (NAC) have been used as internal control and background correction. Plasma samples used a NAC is a RT-PCR positive plasma. We called this method as OnCovid total antibody assay.
A) Binding curve represents detection of total antibodies against SARS-CoV-2 in plasma samples collected from a community who were never being diagnosed for SARS-CoV-2.
B) Binding rate have been calculated on a total of 1487 plasma samples collected from a community who were never diagnosed for SARS-CoV-2 and 123 plasma collected from diagnosed for SARS-CoV-2 using RT-PCR. Found that 81 samples were shows binding rate above 0.1nm out 1487 control sample tested. Line indicate cut off point.
C) Receiver operating characteristic (ROC) curve analysis showing sensitivity versus specificity for discrimination of RT-PCR positive and control plasma samples which were never tested for SARS-CoV-2 (ROC area under the curve: 0.9818, 95% confidence interval in between 0.9663 to 0.9973 and p values <0.0001).