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pharmaceutical & biopharmaceutical pharmaceutical solutions

Pharmaceutical and biopharmaceutical manufacturing includes products from raw material identification, chemical manufacture of intermediates, and manufacturing steps to the measurement of content uniformity. Moreover, the FDA, European Union and other regulatory guidelines have increased the focus on the use of quality initiatives and process analytical technology throughout the product development and manufacturing steps.

Real-time measurement in the product or process

Real-time measurement of product or process
Real-time measurements using advanced control techniques facilitate online prediction and classification of the process parameters and product qualities. This helps have the pulse of the process. If deviations are detected, one can then adjust the process and production parameters like starting material feed rate, temperature, RPM, etc. in real time, bringing the process back to control, and hence maintaining quality. The ability to make measurements in real time, ensuring product quality throughout, can also reduce delays in manufacturing as materials can be released to the next unit operation without the need for off-line analysis.

Process Analytical Technologies (PAT) & Quality by Design (QbD)

Process Analytical Technologies (PAT) & Quality by Design (QbD)
A process centric approach to quality starts at the early design stages of the process and continues throughout the entire life-cycle of a product. The use of PAT tools including MVA are key in gaining process understanding. Real-time prediction and classification of products and processes brings manufacturers one step further to mastering their process and product control.

Quantitative Analysis and Quality Control

Quantitative Analysis and Quality Control
Release or reject raw materials and finished products in minimal time. Reduce the need to wait for results from the Quality Control laboratory and enhance the Quantitative Analysis and Quality Control processes.

Trace Results & Models

Trace Results & Models
Trace and measure data directly acquired from instruments for experimental design, process monitoring and control. Strategies involves multivariate data analysis, off-line model predictive control, online process monitoring and prediction.

Standardize & streamline formulations

Standardize & streamline formulations
Validate and regulate information or data collected from all raw materials, production steps and final product. Integrate, manage and apply data models to the outputs of various third party process sensors.


Project Examples

Services

  • PAT & QbD
    • Training: Multivariate analysis for Process Analytical Technology (PAT) and Quality by Design (QbD)
    • PAT and QbD project management
    • PAT development and implementation
    • Integration of The Unscrambler® Technology into existing PAT environment
  • Statistical and chemometrics training
  • Design of Experiment expertise
  • Process optimization expertise
  • Quality control expertise
  • Data analysis expertise
  • Spectroscopy expertise

 


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Project Examples

Spectroscopy | Sensory | Chemometrics | Multivariate Analysis | Design of Experiments | Process Analytical Technology
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