Imagine the scenario: an insulin production facility is forced to shut down, or production ceases, limiting the availability of insulin to diabetics around the world.
It’s a disturbing picture and reinforces the fact that biomanufacturers need to put strategies in place to mitigate risk and ensure their products are available for patients when they need them.
Risks to manufacturers can be categorized in many ways. The adoption of single-use technology in biopharmaceuticals manufacturing has changed the nature of the risk that producers face.
For example, the risk of cross contamination between batches in multi-product facilities has reduced, as have risks from failed cleaning and steaming regimes. Yet the increased proliferation of single-use technologies means there is a need for greater oversight of supply capability and quality risks throughout the supply chain.
So how can biopharmaceutical manufacturers counter the threat posed by supply chain and manufacturing process risks?
Here are some solutions from Parker domnick hunter:
- Qualify more than one supplier - Parker domnick hunter’s ‘Open Architecture’ approach to the design of single-use systems allows customers to utilize filters from their suppliers of choice.
- We approve second suppliers of components – an important precaution.
- Parker domnick hunter puts in place site contingency plans – these can help to minimize disruption should a problem arise.
- We can manufacture products at multiple locations.
- We operate to a high standard of quality risk management – this is essential throughout the single-use component’s life cycle, from design to disposal.
- Parker domnick hunter’s overmolded single-use assemblies protect the process from contamination and minimize the risk of operators bring exposed to potent biological molecules. The time-consuming task of tie-wrapping tubing together is also avoided.
Most critically, Parker domnick hunter’s ‘Open Architecture’ single-use systems allow users to mitigate process risk by implementing automation and sensing into operations which were previously carried out manually.
- Our pre-calibrated single-use sensing technology eliminates contamination risks during offline calibration and enables process reproduction.
- Parker domnick hunter’s SciLog® sensors can be gamma irradiated or autoclaved and are suitable for cGMP environments.
- Automated systems reduce variability between operators.
- Automated systems also protect your process if the unexpected happens: their control strategies maximize filtration performance and adverse event detection.
A full version of this article appeared in issue one of Parker domnick hunter's Your Partner in Bioprocessing magazine.
Parker domnick hunter, specialize in automating and controlling single-use processes. By integrating sensory and automation technology into a process, a manufacturer can control the fluid flow more effectively, ensuring the quality of the final product.