BioPharma Engineering are trusted experts in the delivery of peptide production facilities projects. We have a strong track record in supporting our clients across Secondary, Bio, Sterile and Aseptic design. Our expertise covers synthesis, extraction, purification and lyophilisation in new and retrofit facility design..
KEY INDUSTRY TREND
The multicolumn countercurrent solvent gradient purification (MCSGP) process principle has been developed as an innovative technology for biomolecule purification at a lab and commercial scales.
ADVANTAGES AND PRODUCTIVITY GAINS FOR MCSGP PURIFICATION
According to the ISPE, the MCSGP purification process has significant advantages compared to single-column batch chromatography, including:
The process principle allows running steep gradients and applying higher flow rates. Productivity increase can be up to 10-fold higher than with conventional batch processes.
2. Higher Yield
Depending on feed purity, product purity specification, and the extent of overlap of product and impurities, a 40%–90% higher yield can be obtained without compromising target purity.
3. Lower solvent consumption:
The increased yield leads to reduced solvent consumption. Solvent consumption is typically reduced by 70%, and solvent savings are even more accentuated under conditions of feed material overloading.
KEY DESIGN CONSIDERATIONS
For scale-up, the quality of pump performance is very important.
Although chromatographic process modelling is not required to design an MCSGP process, it can be used to speed up process development.
Similarly, as in single-column chromatography, a risk-based approach is used, testing process parameters and multiple sets of operating conditions, corresponding to different steady states to characterize the process and identify critical process parameters.
- Reduced stationary phase costs
- Reduced column dimensions
- Reduced equipment requirements for pumps, pressure rating
- Reduction in QC sampling and testing
- Reduced solvent consumption
BioPharma Engineering were recently engaged by our client for the Concept, Front End & Detail Design Deliverables for a new Peptide Suite. A fallow space within a recently constructed building is allocated to the new Peptide Suite. The new Peptide Suite is to be routinely used for the manufacture of peptides.The project successfully delivered new equipment and process facilities to support key site strategies within a live production plant with no impact on production targets. Read full case study here
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