BIOVIA Biologics
Biologics Made Right First Time Industry Process Experience

Minimizing process variability and patient risk by leveraging process and quality data to improve decision-making across the production enterprise

BIOVIA’s Made Right First Time Industry Process Experience is a validation-ready solution for bioprocess and quality data access, aggregation, contextualization, analysis and reporting to drive effective bioprocess design, performance and improvement. It allows for close collaboration in a flexible environment for decision making about how the biologics process operates and provides visibility for all stakeholders into bioprocess and quality performance. It helps shorten time to market and maximize profitability by enabling understanding of critical bioprocess drivers, monitoring variability for preemptive action and leveraging opportunities to maximize sustainability.

Bioprocess Design

Improve process design by understanding the critical bioprocess parameters:

• Identify Critical Process Parameters (CPP) and operating ranges required for sustainable bioproduction process and product quality (Critical Quality Attributes – CQA) at commercial scale
• Scale-up and transfer of a validatable bioprocesses with built-in quality (Quality by Design – QbD) for in-house or contractor operations
• Establish a culture of data for bioprocess knowledge sharing and collaboration
• Accelerate the preparation and approval of science based submissions to speed time to market

Bioprocess Performance

Increase bioprocess performance, quality and compliance by monitoring variability enabling preemptive action:

• Ensure bioprocess robustness through ongoing verification of performance as designed (Continued Process Verification – CPV)
• Maximize productivity and minimize costs with automated alerts and monitoring-by-exception.
• Establish a culture of ownership with visibility, communication and collaboration across internal and external organizations
• Reduce the cost of periodic reporting for review and compliance (Annual Product Review – APR, and Periodic Review – PQR)

Bioprocess Improvement

Enhance process improvement by understanding and control bioprocess and product variability:

• Improve economics by identifying, reducing and controlling sources of variability and maximizing yield, quality, and sustainability
• Accelerate preparation and approval of ongoing science based submissions for Scale-Up and Post-Approval Changes (SUPAC)
• Reduce costs of deviations with near real-time data access and advanced analytics
• Establish a culture of production and compliance excellence

Management of Biologics Information throughout the Product Development Life Cycle
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