Biotechnology. The Flexibility to Handle Complexity.

With complex biological manufacturing processes and controls, biotech manufacturers have unique demands while still facing all the compliance challenges of pharmaceutical companies. They need to accelerate time-to-market and improve the profitability of new products, while also implementing compliance around their scientific complexity.

Modelling your manufacturing processes

Biotech manufacturers are looking for ways to translate their science into stable, highly visible manufacturing processes and need manufacturing systems that model those processes while implementing the strong controls that the industry demands. The right technology and automation solution can allow biotech manufacturers to:

• Adapt their controls to evolving regulatory requirements such as FDA, cGMP, 21CFR Part 11 and more
• Translate their science to ensure the safety, quality and traceability of manufactured products
• Model processes to enable increased productivity and lower costs
• Readily translate scientific changes into continuous improvement strategies with the view to increased competitiveness

XFP-MES: Flexible, pre-validated, solutions designed for biotech

In the blurred biotech lines from product development, through complex batch records, to stable, compliant production, the XFP-MES suite provides modular and flexible solutions that:

• Align processes with regulatory compliance
• Reduce risks and increase visibility
• Reduce process cycle time and optimize resource use
• Allow quick configuration of manufacturing control steps to streamline manufacturing through to batch release
• Use validated system tools to keep the complexity inside a solid validation foundation

Controlled production, real time visibility

Seamlessly integrated with ERPs and any other components of the supply chain, XFP-MES maintains the complex web of information and oversight required in the manufacturing of biotech products.

Operational excellence through technologies that adapt to your processes

Through the use of strong configuration and version-control tools, the XFP-MES suite is an essential technology solution for reducing change control time- and resource-demands and allowing for rapid optimization of processes. There is no need to sacrifice scientific complexity to fit into your MES controls; the controls are built within the process model itself. The reduction in challenges in design and change control allows for easier enhancement of the visibility of key process elements, which enables the organization to rise to the level of operational excellence desired.