As innovative biotech company, you benefit from Exputec’s consulting experience in applying the right statistical tools for process development, process validation and quality controls. You significantly streamline your interactions with regulatory authorities such as FDA and EMA by adopting statistical best practices.
Process Development
You are looking for…
- Experimental designs for process development & characterization studies
- Exhaustive statistical analysis of your process develoment & characterization studies
- Integrated Process Modelling
- Scale-down model qualification
- Risk assessment facilitation, evaluation, or linkages to development data
Quality
You are looking for…
- Continuous process verification (CPV)in a GMP environment
- Statistical control of quality metrics
- Confirmation of equivalence for change control
- Analytical method development of Bioassay
Validation
You are looking for…
- Process Characterization
- Design of Experiment: planning or analysis
- Risk assessment: holistic and data based
- Scale-down model qualification
- Criticality assessment: CPP / CQA identification
- Establishing limits: NOR, PAR
- Justification of PPQ Runs
- Integrated process modelling
Process Engineering MS&T
You are looking for…
- Yield-improvement study plans
- GMP Data mining and analysis
- Integrated Process Modelling?
- Problem solving using statistical data mining and structured methodology
Operations
You are looking for…
- Soft Sensors: Optimization and development
- Real-time uni/multi variate parameter analysis during production
- Development and analysis of PAT technologies
Talk to one of our data scientists
We’d love the opportunity to answer your questions. Contact us now and one of our experts will get in touch with you shortly.
Customer Voices
Statistical Services for Process Development
“High quality data science services with deep bioprocess understanding! We appreciate the timeliness and flexibility of the statistical consultants. This enables us to efficiently develop and validate bioprocesses, ranging from new biological entities to biosimilars, with minimal experimental effort.”
Statistical Services for Process Characterization Studies at JHL Biotech
“We greatly value the services that you provided us. The timeliness in response and professional interaction have been great! You have established your credibility through your actions!”
inCyght for GMP Quality labs: Bioequivalence Testing
As a leading analytical service provider and biotech laboratory in the field of Biosimilars, we support many customer projects involving biosimilar clone screening as well as comparability studies. Our clients need to select the right clones with minimal analytical effort and highly consistent data. With inCyght® software, we now have a tool in hand to explore which clones or process conditions perform most similarly to the originator product. Furthermore, we can explore which process parameters and settings achieve the highest biosimilarity score.
Exputec inCyght® bioprocess software at biotech R&D site at Evonik
- Successful roll-out of Exputec inCyght® at R&D unit of Evonik’s Business Line Animal Nutrition in Künsebeck.
- Operators, scientists, engineers use Exputec inCyght® for bioprocess development and optimization.
- Manifold bioprocess equipment sucessfully integrated for data analytics using Exputec inCyght®.
- Seamless integration in existing IT infrastructure.
Digitalization and Data Analytics to Accelerate Bioprocess Development
“We found an excellent realization partner in Exputec. The project team is very focused on our business needs and all interfaces are running smoothly and reliably. The collaboration is excellent.”
inCyght software as collaborative data analytics platform
“We use inCyght Software for data management, data analytics and as collaborative platform in the multi-partner EU project CrossCat”
inCyght for Scale-Up and Scale-Down of Biopharmaceutical Processes
Scale-dependent challenges were overcome for the successful scale-up of a biopharmaceutical manufacturing process and the qualification of scale-down models. This was achieved using similarity analysis for the qualification of bioprocess scale-down models, root cause analysis workflows and improvement of scale-up based on industrial best practices.
Activating the Design Space for cGMP manufacturing
Using InCyght data analytics software from Exputec, users create integrated process models and soft-sensors. Models can be implemented as soft-sensor function-blocks in Siemens DCS for manufacturing under cGMP and Part 11 compliance.