Scaling up
In microbial fermentation and development our bright science is helping a new generation of patients benefit from sustainable biopharmaceuticals.
If you have a project in the pipeline and need to scale it up quickly and reliably, we’re a trusted and proven safe pair of hands – able to help you choose the right technologies and processes and streamline activities with a firm focus on fast time to market and competitive cost of goods.
Early stage
Microbial fermentation is of course an established (bio)pharmaceutical production process.
Our process design capabilities range from the basic production strain up to the target product at the required quality. They’re based on our long-term experience in a multitude of microbial production processes for a wide variety of products.
Together with customers we create the best possible starting point for high quality products at the most competitive cost of goods.
C2
A stable, robust and consistent process is critical to your production process - especially for biopharmaceuticals with very complex molecular structures.
In process development we offer you ready-to-use technology platforms that provide predictable and straightforward scale-up; minimizing the need to demonstrate equivalence of a product with the scaled-up process; and helping define the optimum fermentation and purification routes.
These technologies include standardized expression platforms, with ready-to-use, robust and scalable fermentation and recovery processes; as well as a state-of-the-art analytical toolbox, including high-throughput screening technology, for fast and reproducible results.
C3
We know that scaling up for C3 stage is often a make-or-break decision for customers – which is where our track record, regulatory history and wealth of resources and analytical expertise have been proven again and again.
That means the ability to deliver the correct volumes on time, and on budget. Speed and scale-up is paramount. We can draw on a huge amount of experience in Tech Transfer aided by a production environment that meets or exceeds all regulatory requirements.
Commercial
Our manufacturing excellence program and our strict process control (including a validated SAP system and strictly enforced well being and safety procedures) mean batch after batch comes out at high, consistent quality.
As you’d expect from us, we offer major-scale fermentation capacity at the highest levels of quality and consistency for fermentation-derived APIs, including small molecules, therapeutic proteins and enzymes – and all with guaranteed security of supply: In fact, our Capua plant has been established and producing at the highest quality for decades.
we also have a dedicated Finished Dosage business able to formulate APIs in liquid form, as well as final filling with water for injection (WFI) and sterilized air. We can combine APIs with additives; and we offer stabilization steps for transportation and storage.
Off-patent
The market and opportunity for follow-on biopharma products is growing fast – but the window is inevitably short.
This is another area where our customers can benefit from our unique blend of capabilities, particularly in achieving a superior cost of goods through technologies, scale-up, and the ability to design second generation processes.
Again, this is supported by our excellent regulatory knowledge and record. We’ve walked this path many times before – we invite you to join us.