Consulting

Exputec combines bioprocess knowledge and data driven analytics with deep, practical industry expertise

Header Image - Bioprocess Data Management, Data Analytics and Statistical Consulting

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

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Customer Voices

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.

Rainer Fedra, Head Analytical Development at VelaLabs GmbH

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.”

Read more about this collaboration.

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”

 

 

Ass. Prof. Oliver Spadiut

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 modelsroot cause analysis workflows and improvement of scale-up based on industrial best practices.

Dr. Sandra Abad

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.

Dr.-Ing. Bernd-Markus Pfeiffer