| Flexibility for development. Controls when they're needed. |
As drug development programs evolve, laboratories need workflows that can adapt without slowing progress. Additional documentation, traceability, and review requirements often emerge as projects mature, creating pressure to balance flexibility with oversight.
BioPhase software 1.6 helps laboratories align with project requirements while maintaining continuity across development activities, allowing teams to adapt as programs mature without introducing unnecessary disruption.
| Built to support evolving workflow requirements |
Early-stage development often prioritizes speed and flexibility, while later-stage projects may require greater oversight, documentation, and review processes. BioPhase software 1.6 allows laboratories to align user management with project requirements and apply the level of governance that fits the work. |
Incorporate configurable access controls, audit trails, electronic signatures, and project management capabilities to support alignment with regulatory guidance.
| Maintain continuity |
Use a common software platform across development activities while accommodating evolving documentation, review, and traceability requirements. |
| Be ready for reviews and audits |
Strengthen end-to-end data traceability and approval processes through electronic signatures, authority checks, and digital, searchable projects. |
Manage system access through configurable user access, user roles, and project access capabilities aligned to organizational requirements. Capabilities include:
|
Choose the operating model that best aligns with your workflow requirements, maintaining streamlined development workflows today while making additional controls available as programs evolve. Workstation mode Maintain a streamlined environment for method development, sequence creation, and data analysis without dependence on BioPhase Project Management software. Enterprise mode Incorporate controlled access management, audit capabilities, user permissions, and electronic signature workflows through BioPhase Project Management software. Benefits include:
|
Gain visibility into workflow execution through configurable audit capabilities, and one searchable record of what happened, when, and why. Capabilities include:
|
Help streamline review and approval workflows through electronic signatures linked to user identity, date, time, and approval actions. Capabilities include:
|
Incorporate workflow traceability, access controls, audit trails, and electronic record management capabilities into everyday laboratory operations. Capabilities include:
|
Take advantage of a flexible platform for multiple analytical assays with a temperature-controlled capillary for the highest data reproducibility and confidence.
Discover a flexible platform with parallel processing designed to deliver consistent, comparable and compliant data at scale across the drug development continuum.
Support core industry workflows with validated kits. Adapt quickly with kit-based workflows designed to support core industry assays on SCIEX CE instruments.
From remote sequence execution and real-time instrument monitoring to allowing workflow orchestration and automated data acquisition, the BioPhase Instrument API helps development teams scale to meet the demands of modern biopharma.
Reclaim time for innovation by identifying and advancing drug candidates more confidently with analytical strategies that support your team across modalities, from discovery to commercialization.
Break through barriers and extend the frontiers of mRNA, saRNA, and circRNA development with intuitive analytical solutions. Confidently innovate with high-quality, sensitive, and accurate data to assess integrity, purity, and CQAs.
Advance your projects with purpose-built solutions for the analysis of pDNA and dsDNA to support the development of your mRN), viral vectors, recombinant proteins, and other new modalities.
Optimize your processes with solutions that overcome the analytical challenges of viral vector-based drugs. Take control of full and empty ratios and protein and genome profiles. Break down the boundaries of protein and post-translational modification (PTM) characterization with dedicated high-resolution workflows offering unprecedented depth.
Set your own schedule for CRISPR/Cas9 gene editing with innovative, intuitive analytical solutions. Unleash the potential of your Cas9 mRNa, sgRNA, and Cas9 proteins by understanding quality, purity, and safety and assessing on/off target effects.
Set the pace with confidence. Cell line monitoring and analysis solutions verify the identity, purity, and stability of lead candidates with high throughput strategies that are ready for automation.
Fully understand drug candidate glycoprofiles with pipeline-specific solutions. Gather critical high-resolution information and site-specific data points with advanced glycan analysis for complex biologic development.
Pursue the end goal with confidence. Achieve the full picture and accelerate decisions with comprehensive characterization of biopharmaceutical charge variants.
Discover how CE‑SDS enables quantitative purity assessment, estimation of product‑related impurities, and batch‑to‑batch consistency across the drug development lifecycle—supporting informed decision‑making and delivery of safe, effective therapies.
Stay up-to-date with biopharma conversations on LinkedIn
BioPhase software 1.6 expands workflow control capabilities within the BioPhase platform through configurable user management, audit trails, electronic signatures, workflow traceability, and project management capabilities designed to support workflows operating under GxP requirements. |
BioPhase software 1.6 helps laboratories align workflow controls with project requirements while maintaining continuity across development activities. Teams can introduce additional permissions, documentation practices, and controls as programs mature without disrupting established workflows. |
Yes. BioPhase software 1.6 includes configurable access controls, audit trails, electronic signatures, and project management capabilities designed to help laboratories support workflows operating under GxP requirements. |
Workstation mode provides a streamlined environment for method development, sequence creation, and data analysis. Enterprise mode adds controlled access management, audit capabilities, user permissions, and electronic signature workflows through BioPhase Project Management software. |
Yes. BioPhase software 1.6 allows laboratories to introduce workflow controls, permissions, and documentation practices when required while maintaining flexibility during routine development activities. |
BioPhase software 1.6 includes configurable audit capabilities that capture user actions, project activities, and system events. It also provides searchable audit information and workflow traceability capabilities. |
Yes. BioPhase software 1.6 supports electronic signatures linked to user identity, date, time, and approval actions, along with multi-level approvals and authority-based review workflows. |
BioPhase software 1.6 incorporates workflow traceability, access controls, audit trails, and electronic record management capabilities to support data integrity and record management across laboratory workflows. |
BioPhase software 1.6 allows laboratories to align workflow controls with evolving project requirements, maintaining streamlined development workflows today while making additional controls available as programs evolve. |