Automated Process ModelingAssessment
with our Frame-by-Frame Solution
Our Frame-by-Frame Solution automates process design and risk assessment in aseptic manufacturing, cutting production risks and time-to-market while ensuring quality and compliance.
Automated Process
ModelingAssessment
with our Frame-by-Frame Solution
Our Frame-by-Frame Solution automates process design and risk assessment in aseptic manufacturing, cutting production risks and time-to-market while ensuring quality and compliance.
Status Quo in Pharmaceutical Manufacturing
Pharmaceutical manufacturing demands the highest standards of quality, safety, and regulatory compliance. The production of every new drug, every new therapy and every new medical device requires the development of complex pharmaceutical manufacturing processes that can take months, sometimes years. Subjectivity in process design and risk assessment often leads to risks that can have serious consequences for patient safety and product availability.
With rising new drug approvals and demand, the pharmaceutical manufacturing industry is facing the challenge to accelerate and scale manufacturing, adapt fast to new market demands and meet regulations without compromising product quality.
62% of drug shortages result from quality issues, and advanced manufacturing can help to address supply disruptions.
Michael Kopcha
Director of the Office of Pharmaceutical Quality in the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER)
Our Solution for Safer & Faster Manufacturing
We solve fundamental problems in aseptic manufacturing by offering an automated, data-driven approach that integrates all aspects of process design, risk assessment and knowledge management. This reduces time-to-market and production risks while enhancing quality and regulatory compliance.
Our Frame-by-Frame Solution is enabled by the Process Frame Library, a central database containing detailed information on thousands of unit operations and process steps. We leverage this extensive data to generate multiple Process Model variants. By conducting a thorough Risk Profiling and comparing the variants, we can identify the most effective and efficient process that contains the least amount of critical risk. To implement the optimized process, our Knowledge Management system generates process documentation, provides quality monitoring guidelines and offers a tailored training program for personnel.
Key Benefits of Frame-by-Frame
Automated & Objective
Process Modelling
Our Frame-by-Frame Process Modelling speeds up decision-making in process design and improvement to a matter of weeks, not months or years. By generating and comparing multiple Process Model variants, we save manufacturers precious time and resources to get more medicines to patients faster and with less risk.
Automated & Objective
Risk Profiling
Automated & Objective
Knowledge Management
2024 Conference Sessions & Presentations
Given the strong interest from the industry, we actively present and discuss our solution at conferences to showcase its potential and diverse use cases. Explore our lineup of 2024 presentations:
- End-to-End CCS in CGT through advanced risk profiling | Genap Summit – Gene & Cell Therapy | Feb 22, 2024
- Frame-by-Frame Risk Profiling: How digital process twins overcome barriers to develop robust manufacturing processes | ACHEMA | Jun 11, 2024
- Achieving Compliance: Validating VR-Training in Pharma | ISPE Aseptic Conference | Mar 19, 2024
- Autogenerated Risk Profiles to accelerate process-design | ISPE Biotechnology Conference | Jun 18, 2024
- Frame-by-Frame: How digital process twins overcome barriers to develop robust ATMP manufacturing processes | PDA ATMP Conference | Jun 25, 2024
- Fast-Track to Robust Manufacturing: Case-Study from Frame-by-Frame Risk Profiling at Kindeva | PDA/FDA Joint Regulatory Conference | Sep 10, 2024
- Accelerated the development of a robust manufacturing setup for a brand new Kindeva fill-finish site | PDA BioManufacturing Conference | Sep 23, 2024
- Frame-by-Frame: Robust & fast process design at Kindeva | ISPE Annual Meeting & Expo | Oct 14, 2024