Scaling a microbial process is the critical step that converts successful biological proof-of-concept into a robust, scalable manufacturing system attractive to investors. It is also where many projects stall: the physics changes, variability increases and "lab success" stops predicting performance at pilot and manufacturing scale.
Isomerase provides bioprocessign services that help partners move from bench experiments to reliable, transferable processes; combining upstream and downstream development and scale-up through CDMO network.
What is microbial bioprocessing?
Microbial bioprocessing uses engineered microorganisms to produce valuable products, such as proteins, enzymes, and small molecules, at industrial scale. Once the production strain and target are optimised, the decisive work is process design: how to reproduce performance when hydrodynamics, oxygen transfer, mixing times, and stress responses no longer behave like they do at bench scale.
For many teams, to outsource bioprocessing is the most efficient way to bridge this gap: turning lab performance into a robust, scalable and transferable process.
Scale-up is not linear
Scale-up is rarely a simple "multiply by volume" exercise. What changes is the operating regime:
- Mass transfer limitations (especially oxygen transfer)
- Mixing gradients across the vessel
- Shear and foam behavior
- Metabolic state variability throughout the tank
- Downstream impurity and stability shifts
The goal is not only peak yield, rather robustness, repeatability and manufacturability, outcomes you protect when you outsource bioprocessing with scale and transfer in mind.
DoE-led process optimisation for faster learning
Isomerase uses statistically Design of Experiments (DoE) to map process space efficiently, identify what truly drives outcomes from noise and define operating windows that hold up at scale.
Why outsource bioprocessing?
Most organisations can run lab fermentations. Far fewer can industrialise a process without excessive time, capital and rework. Outsourcing bioprocessing services tends to win when these constraints apply:
- Capex is misaligned with need. Pilot equipment, analytics and specialists staffing are expensive while scale-up demand is often episodic. Outsourced bioprocessing lets you access capabilities without long-term fixed costs.
- Speed is a strategic variable. Delays compound: funding milestones slip, customer timelines drift, IP strategy weakens and market positioning erodes. Outsourcing bioprocess development helps you compress timelines.
- Scale-up is a risk management problem. The dominant failure mode is not "no yield", but inconsistent yield, untransferable protocols or purity/quality drift and downstream bottlenecks. Outsourced bioprocessing reduces these risks by designing for transfer and control early.
- Your scarce resource is learning rate. The most valuable partner is the one who has seen the edge cases before. If scale-up is not your core operational competency, it is usually better to buy the learning curve than build it from scratch.
Outsourced bioprocessing services at Isomerase
Outsource bioprocessing for more than capacity. The value is accelerating the transition from "works well in the lab" to "works reliably at scale" and preventing the costliest outcome: an optimised-but-fragile process that cannot be transferred to manufacturing.
Isomerase’s bioprocessing platform runs three critical workstreams simultaneously: rapid learning, minimized scale‑up risk, and delivery of a fully transfer‑ready process package. When you partner with Isomerase, you benefit from:
- Integrated Process Development Expertise: our team integrate yours providing access to 20+ years of process development experience. We diagnose and overcome the scale-depedent failure modes that emerge beyond lab scale, so performance holds up in pilot and manufacturing scale.
- Active Risk Management: each development program includes a risk register. Risks are ranked by likelihood and impact, then actively reduced - shifting development from reactiv troubleshooting to controlled risk burn-down.
- Quality by Design (QbD) Built In Early: We apply QbD principles as the control logic to identify:
- critical quality attributes (CQAs) and critical process parameter (CPPs)
- define space and control strategy
- make quality predictable at scale, not an afterthought
- CDMO Selection Support Through a Global Network: Choosing the right manufacturer is as important as optimising the process. Isomerase provides access to a global CDMO network, helping you select the best fit partner by:
- process type
- scale requirements
- regional manufacturing needs
- regulatory expectations and quality systems
- timeline, capacity and tech fit
Case Studies
Sourcing active compounds for agricultural use | Scale-up to 50,000 litres
Speak with Our Experts
If you are planning to scale a microbial process, or you have already hit a plateu beyond lab scale, Isomerase can support upstream and downstream development and help you identify they right CDMO partner for your application via our network.