An automated data management system to track – screening, engineering and production aspects of Biological clones.
Ocimum Biosolutions offers Sciantis, an end -to-end intuitive tool for Biologics process tracking, standard data management and comprehensive analytics system in Biologics discovery operations. Sciantis™ automates and streamlines the efficiencies of lab processes. The rich set of features includes Biologics registration, Clone and Vector Management, Scheduling reactors, Sampling, Analytics, Location management, upstream (USP), in-process and downstream (DSP) tracking, Analytical results tracking, Report engine, Notifications and work alerts.
Sciantis™ is designed as an enterprise system that can is easily adaptable out of the box for small to large scale Biologics operations. Inbuilt configuration and workflow tools further help the Biologics process specific adoption in quick and most optimized passion. In addition, Sciantis™ is 21 CFR Part11 compliant for electronics records and electronic signatures tracking with full audit trails along with Role based access to multi lab, multi site and multi user support.
Moreover, Sciantis™ is a fully web based system that works well in all popular browsers, support smart devices, built on a strong web based JAVA and open source tools, database independent. Packaged with SOAP based APIs, for 3rd party software’s and systems integration at laboratory and institutional level.
KEY FEATURES AND MODULES
- Primary Biologics molecules such as Cell lines, Antibodies, Proteins, Clones and molecular tools such as Antigens, vectors, inserts, and pools.
- Unique identifiers, Barcoding, Batches
- Track physico-chemical properties, USP and DSP properties
- Robust search and reporting engine
- Integrated protein and nucleotide sequence analysis tools
- Protein and Antibody sequence views, annotations and identifying glycosylation, deamination, or oxidation sites
- Vector and Gene sequence viewers, annotations, vector design and expression system design.
High-throughput Plate Management
- Standard 96, 384 and 1536 well formats support and MTPs types.
- Plate 1D and 2D Barodes, Genealogy support, Aliquots and Derivatives
- Interfacing with liquid handlers, pipetting robots.
- Design plates layouts – define cell lines, negatives, blanks and controls
- Plate transfers, cherry picking, excel sheet integration for import and export data
- Plate transfers to DSP labs, plate observations
Vector Design and Management
- Vector construction and Vector database
- Store gene of interest, promoters, inserts, and cloning protocol tracking
- Track vector usage in Cell line reengineering
Cell line Management
- Maintenance of Cell Lines
- Track and Manage primary Seed Lot (PSL), Master Cell Bank (MCB), Working Cell Bank (WCB)
- Cell Line Genealogy
- Recording Cell line characterization tests results
- Search for the Cell Lines and cell Line lots based on their attributes
Scheduling Reactors and Sampling
- Schedule Reactors for culturing of cell lines.
- Track details of cell line used for culturing in Reactors
- Track and manage Sample collected at different time points from a reactor
- Sampling of cell cultures based on schedule time points
- Unique identification of sampling lots, plating, distribution to Analytical labs
- Predefined analytical test templates, Protocols, Test attributes and standards definition.
- Workflow based test execution
- USP and DSP process mapping
- Analytical results tracking and Automated data capture from Analytical instruments
- Resource, Cell lines, Instruments, and Protocol integration with workflows
- Result approvals and re assay and re test tracking
- Compare results with standards, Results QC
- Standard analytical parameters and test methods reporting in predefined report templates
- Easy tracking and correlation of analytic parameters with MCB and WCB
- Trend analysis, Clonal screening and Selection criteria
Search and Reporting
- Integrated, powerful Search & reporting tool
- Single and Multi-Parameter Queries
- Personalize queries
- Canned and on demand reports
- Standard report export and sharing formats (word, spread sheet, pdf, csv and email)
- SOP/Protocol Management.
- Instrument Interfacing
- Report and Invoice templates
- Workflow design
- Module Design
- Third party software interfacing
- Organization, Facility users, groups management
- Role Management- predefined roles, configurable roles for lab staff, customer, and collaborators
- Customer, Vendor and Collaborators Management
- Utilities – ID & 2D Barcodes, Tasks list, Dashboards, Email notifications
- Administrator – Manage settings, configurations, fields, modules, vocabulary
- Audit trails, User logs, System logs, GLP and GXP, 21 CFR Part 11, CLIA
Software and Usability
- Web based, browser-independent solution
- Works on tablet PCs and Smart phones
- Offered as “On premise” solution and “SaaS” model
- APIs for easy, faster and secured data exchange with third party software and instruments
- Database Independent