Mammalian Cell Culture

From WCB through shake flask, wave bag and progressively scaled culture vessels to production bioreactor inoculation — MES manages the chain of identity, the seed train recipe and the batch records at every scale. Seed train variability is one of the most preventable causes of production bioreactor failure. We configure the MES recipe logic so every scale-up step is executed consistently and documented automatically.

DCS controls temperature, pH, dissolved oxygen, agitation, gas overlay and nutrient feed — the CPPs that determine whether the cell culture performs as intended. We configure the DO cascade properly, build the fed-batch feed profiles against validated parameters and design the alarm philosophy so operators are alerted to what matters. MES executes the batch recipe, captures in-process checks and manages deviation handling.

DCS manages flow rates, pressure differentials and filter integrity across centrifugation, depth filtration, polish filtration and guard filtration. MES records the harvest batch and holds progression if acceptance criteria are not met. We design these sequences so that an out-of-specification condition is caught and documented before anything progresses downstream.

The capture step — whether Protein A affinity, mixed-mode or an alternative resin depending on the molecule — is configured by DCS as a multi-cycle sequence: equilibration, load, wash and elution, with UV breakthrough monitoring, pressure alarm management and flow control. MES manages cycle sequencing, pool fractions and acceptance criteria. Pooling decisions are built into the recipe logic automatically, with full traceability in the batch record.

DCS enforces the pH set point with properly tuned acid and base addition loops and manages the timed hold. MES records in-process pH readings and hold duration against the batch record without the possibility of manual transcription error. We build this sequence knowing it will be the first thing a regulator looks at — the control logic, alarm limits and batch record format are designed with that scrutiny in mind from the outset.

Sequential chromatography and filtration steps, each with its own DCS control logic for flow, pressure, gradient and UV — and MES tracking pool fractions, acceptance criteria and sublet split decisions across each step. We design the downstream automation as an integrated sequence with standardised DCS-MES interfaces across every skid, not as individual controllers that happen to be in the same room.

DCS controls transmembrane pressure and permeate flux. MES tracks concentration factor, diavolume count and final DS adjustment against the validated recipe. We configure the control loops to respond to what the process is actually doing across the full operating range — not just to hold a static set point at the design flow rate.