Process Analytical Technology (PAT) for bioproduction of vaccines and biomedicines is one of the domains where our company has invested significant efforts in order to offer a cutting-edge solution for the industry. ProCellics™ is the first GMP in-line and real-time Bioprocess Raman analyzer.

Challenges

process analyticsBiomedicines, among which vaccines and monoclonal antibodies are the most widespread, offer very promising prospects for addressing globally the current needs in healthcare. It is acknowledged in the Pharmaceutical industry that the complexity of upstream cell culture development and downstream bioprocess makes it a challenge to maintain a profitable industrial activity based on these products.

Responding to unsatisfied needs

  • Better understanding cell culture processes
  • Improving quality control of the final product by implementing Quality by Design (QbD)
  • Enhancing batch yield and prevent batch failure by implementing in-line cell culture monitoring
  • Speeding up process development, scale-up and transfer to production
  • Fulfilling regulatory requests

Quality by Design (QbD), including Process Analytical Technology (PAT) tools are expected to highly contribute to face these challenges by designing, analyzing and controlling pharmaceutical manufacturing processes, in particular for vaccines and biologics. This is achieved through the robust measurement of Critical Process Parameters (CPP) which are used to ensure that the resulting product will comply with the required Critical Quality Attributes (CQA).  MultiVariate Data Analysis (MVDA) is the cornerstone of information processing in these systems, with mathematical tools such as Principal Components Analysis (PCA) and Partial Least-Squares (PLS) or Support Vector Machine (SVM). The right choice of sensing technology, methodology of measurement, and mathematical tools is essential to implement an efficient and reliable Process Analytical Technology solution. This is particularly true for material such as CHO cell culture used for biodrug manufacturing, because variability can be significant with living organisms.

Raman spectroscopy has been recently demonstrated as a very efficient Process Analytical Technology instrumental technics for upstream development and bioprocess monitoring, in particular for predicting concentration of conventional metabolites in the cell culture (monitoring of lactate, etc.) and then for monitoring the feeding nutrients (monitoring of glucose, medium feeding, etc.). However dissemination of this solution needs a Process Analytical Technology sensor, understood as integrated, robust and easy-to-use system.

The challenge of implementing in-line Raman monitoring of bioprocess also deals with the combination of instrumental, data processing and bioprocess skills.

Solution

RESOLUTION Spectra Systems offers ProCellics™, an integrated GMP in-line Bioprocess Raman analyzer, dedicated to and optimized for the upstream on-line quantitation of glucose, lactate, glutamate, ammonium, other amino acids and Viable Cell Density (VCD) inside a cell culture bioreactor.

  • ProCellicsTM GMP Raman analyzer and probe designed for cell culture monitoring
  • ProCellicsTM Software dedicated to the building of chemometrics models and real-time monitoring
  • Services and support to ease implementation and maintenance

Benefits

With ProCellics™ bioprocess Raman analyzer, we offer a user-friendly and easily deployed Process Analytical Technology solution specifically targeted to cell culture monitoring as well as monitoring of downstream processes developed for the bioproduction of vaccines and biomedicines – relieving the user from conducting a costly and time-consuming study of a Raman analyzer application.

  • Access to high-performance in-line monitoring of metabolites, nutrients (glucose, lactate, ammonium, glutamine, glutamate, other amino acids and proteins) and cell densities  in the cell culture
  • Compact GMP design dedicated to bioreactor environments for an easy implementation
  • ProCellicsTM Software provides a guidance to ease chemometrics model building and Process Analytical Technology monitoring with the required interfaces and regulatory compliances in the field

Raman spectroscopy for metabolites and nutrients in-line quantification

Monitoring of key culture attributes with ProCellics™ Software