"IF IT IS NOT DOCUMENTED, IT NEVER HAPPENED"
Genetic Immunity has an integrated IT and biotech approach that is exceptional for value creation in the biotech industry and demonstrates the Hungarian ingenuity. The integration of bioinformatics and mathematics into our everyday workflow significantly improves our competitiveness because it provides efficient, accessible and high quality data and information collection and distribution throughout the entire research and development and commercialization processes. Our IT team consists of informaticians and mathematicians who are dedicated to support our business agenda. They are essential part of our patient-driven technology platform, providing us innovative solution to daily challenges including data capture, evaluation and storage of experimental data, website design, literature search, 3D visualization of the skin penetration of our nanomedicines based on fiber-integrated 2-photon microscopy and auditing the data management and data quality on clinical sites.
Our electronic Clinical Trial Manager (eCTM) including e-CRF and eCTD conform solutions are designed to optimize the clinical development processes, minimize the errors and time to submit different applications and reports to regulatory agencies word-wide.
Our electronic Labor Management System (e-LMS) supports our processes in Chemistry Manufacturing and Control (CMC) provides a competitive advantage in product development by saving time and manpower. e-LMS maintains our Quality Control tests and computerized Standard Operating Procedures (SOP). Deviations from protocols are registered, results are calculated and summarized in a Table format. Data and documents are stored electronically in FolderX, our validated storage platform.
Our API discovery and documentation process is presently supported by two of our proprietary software. The ANTIGENeering software 'collect and mine' research data from different sources and publications to support the pre-decision making and to ensure safe and specific antigen design. The eMINER software is utilized for the determination of the immunological potential (high affinity epitopes) on different human leukocyte antigen (HLA) alleles. With >85% probability we can in silico predict the cellular immune responses of patients treated with our Immune Therapeutic Products. We envision that the eMINER will help doctors to match patients with optimal Products and design specific immune diagnostic tools.