Partnering with a Global Pharmaceutical Company for Large Scale Enzyme Manufacturing
A large pharmaceutical company needed an enzyme manufacturing partner to develop their enzymes from lab to commercial scales.
When a global pharmaceutical company advanced a novel enzyme into an API manufacturing route, they faced a familiar challenge: how to convert a promising laboratory discovery into a robust, scalable and specification-driven manufacturing process, at pace.
The enzyme sequence and early discovery work were already in place. What was required was a partner capable of translating that foundation into industrial reality: selecting the optimal production host, engineering a high-performing expression system, and developing a fermentation and downstream process capable of delivering consistent activity, purity and formulation quality at scale.
----------------------------------------------------------
- Bench to industrial fermentation
- kg-scale delivery
- Assay alignment with client systems
- Commercial supply established
----------------------------------------------------------
Engineering for Scalability from Day One
Our team began by evaluating production platforms to identify the most suitable host for maximal, stable expression. Fermentation parameters were systematically optimised to increase titre while maintaining strict quality attributes aligned to the API process. In parallel, downstream recovery was refined to ensure high-yield purification without compromising enzyme performance.
Crucially, assay methods were developed and aligned with the client’s in-house analytical framework. This ensured data comparability, accelerated decision-making, and enabled a seamless technical dialogue throughout development.
From the outset, the process was designed with industrial scale in mind not as a laboratory solution to be “fixed later”, but as a manufacturing-ready platform.
From Bench to Industrial Fermentation
Development progressed from bench-scale proof of concept to pilot and industrial fermenters, delivering kilogram quantities of quality-controlled material. Across each stage, critical process parameters were evaluated for robustness and reproducibility, ensuring predictable performance as volumes increased.
Working closely with the client, we defined detailed product specifications and release criteria to ensure compatibility with their API manufacturing route. This encompassed enzyme formulation, activity profile, impurity control, stability, packaging and supply logistics all aligned with global supply chain expectations.
The result: a fully optimised enzyme manufacturing process, validated in application with the client’s manufacturing partners and now supplied routinely at commercial scale.
Delivering Value Beyond Scale-Up
This project exemplifies our capability to take a customer-developed enzyme and transform it into a reliable manufacturing asset. By integrating host optimisation, fermentation development and downstream design within one coordinated programme, we reduce technical risk and shorten the path to commercial supply.
Key Outcomes
- End-to-end process development from expression to industrial manufacture
- Enzyme and formulation optimisation aligned to API requirements
- Scalable, reproducible fermentation with predictable performance at large scale
- Seamless transition from development batches to routine supply
For pharmaceutical partners, success is not simply about producing more enzyme, it is about delivering a process that performs consistently, integrates into complex API workflows, and stands up to commercial demand. That is where scale-up becomes strategic, not just operational.
