Bioscience Lab Background
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Process Development & Refinement — Biotrex
03
CDMO Services
Service 03 — Scale & Production

Process Development
& Refinement

Creating the precise recipe for biological production — optimizing every parameter to ensure your process is consistent, cost-effective, and ready for industrial deployment at any scale.

Fermentation Design Parameter Optimization Scale-Up Protocols GMP Readiness
60%
Avg. Cost Reduction
Lab → Pilot
In Under 90 Days
99.2%
Batch Reproducibility

Great biology,
reliably produced

A microbial strain that performs brilliantly in a flask may behave entirely differently in a 500-litre fermenter. Scale-up is where most biosolutions fail — and where we specialize.

Process development bridges the gap between scientific proof-of-concept and commercial reality. We define the exact conditions under which your biological process delivers consistent, predictable results at any scale.

"The biology only matters if you can reproduce it reliably, economically, and at scale."

Biotrex — CDMO Philosophy
ParameterMethodImpact
TemperatureDoE ProfilingYield ↑
pH ControlCascade LoopsStability ↑
Dissolved O₂Agitation MapsViability ↑
Nutrient FeedFed-Batch DesignCost ↓
Harvest TimingPAT MonitoringPurity ↑

From first flask
to full production

Our structured four-phase methodology ensures nothing is lost in translation between the lab bench and the production floor. Each phase has clear deliverables, go/no-go criteria, and documented outputs.

Phase 01
Baseline Characterization

Establish performance benchmarks under standardized conditions. Document nutrient requirements, growth kinetics, and product formation rates.

Phase 02
Design of Experiments (DoE)

Systematically vary critical parameters using statistical design to identify interactions and optimal operating windows with minimum experimental runs.

Phase 03
Pilot Scale Verification

Transfer the optimized recipe to pilot-scale equipment. Validate that performance is maintained and identify any engineering challenges unique to larger volumes.

Phase 04
Process Lock & Documentation

Formalize all parameters, tolerances, and control strategies into a master process document ready for technology transfer or regulatory review.

What You Receive

Tangible deliverables

Deliverable — 01
Master Batch Record

A complete, step-by-step production protocol with all parameters, tolerances, and decision points documented to manufacturing standard.

Deliverable — 02
Scale-Up Roadmap

A phased plan for moving from pilot to commercial scale, including equipment specifications, projected yields, and cost models.

Deliverable — 03
QC Framework

In-process and release testing protocols that ensure every batch meets the performance specification established during development.

Ready to scale your biosolution?

Bring us your strain — we'll build the process that takes it to market.

Discuss Your Process →
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