Who we are
Based at Alderley Park, PCS Biotech was founded with the sole purpose of improving therapeutic protein development and manufacture by enhancing upstream process analytics.
Accurate measurement of Critical Process Parameters (CPPs) significantly improve product yield and Critical Quality Attributes (CQA).
Industry experts at PCS Biotech have developed novel solutions to ensure measurements of in-process samples are accurate, reliable and traceable throughout biomanufacturing networks.
Mission: Through scientific innovation, improve biotherapeutic quality and yield.
Bioprocess EQA
An External Quality Assessment (EQA) programme is an important tool used by laboratories to assess and enhance the quality of sample measurement processes.
For therapeutics, a Bioprocess EQA programme can provide an independent external assessment of In-Process Control (IPC) analytical technology.
By participating in EQA, upstream laboratories can identify areas for improvement and ensure that their test results are accurate, reliable, and comparable.
When AccuCell® EQC is partnered with AccuCell® 360, scientists, process engineers and QA are able to:
- Trend upstream measurement accuracy across several batches
- Streamline tech-transfer and facilitate with bridging studies
- Detect and correct errors that are not visible through daily QC
- Ensure consistency and reliability of cell culture samples
- Identify multi-site differences to reduce variability
Therapeutic CQAs
Monoclonal antibodies (mAbs) are complex therapeutic proteins used in various medical applications. When developing and manufacturing mAbs, it is important to define Critical Quality Attributes (CQAs). These attributes are specific properties or characteristics that significantly impact the safety, efficacy, and overall quality of mAbs.
Process parameters are controllable inputs in a bioprocess and play a crucial role in shaping the CQAs of monoclonal antibodies. When process parameters are optimised or adjusted, they directly impact the quality of the final mAb product, therefore process accuracy is of the utmost importance.
AccuCell® provides independent measurement data to improve product CQAs.
CQAs include:
Molecular Size
The size of the mAb molecule is critical. Deviations from the expected size can affect its function and behaviour.
FcgR Binding
Interaction with Fc gamma receptors (FcgRs) affects immune responses and clearance. Proper FcgR binding is essential.
Glycosylation
Glycosylation influences mAb function, pharmacokinetics, and immunogenicity. Variations in glycosylation can alter these properties
N/C-Terminal
The N- and C-terminal regions play essential roles in stability, binding, and interactions. Ensuring their integrity is crucial.
Charge
The overall charge of the mAb affects solubility, stability, and interactions with other molecules.
Aggregation
Aggregates (clumps) of mAbs can impact safety and efficacy. Controlling aggregation is vital.
Validation
Wide analytical ranges provide measurement data for Performance Qualification (PQ) and Linearity Studies in accordance with ICH Q2
Sample Matrix
The AccuCell® EQC sample matrix is designed to be comparable to cell culture media and analysed using process sample mode
CQA
Improved process control can increase productivity and enhance product quality (CQA), improving experimental outcome and batch release
Reduced Errors
AccuCell® 360, facilitates multi-site data trending, can reduce deviations and predict future process inaccuracy
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