More and more specific treatments are available. This implies that the potential patients for a new drug tend to be fewer. This new trend has a significant impact on the strategy followed by pharmaceutical companies. The revenue generated from the sales of a drug may not be enough to justify dedicated production in a plant.
Faced with this situation, the industry is moving towards the most economically viable solution: multi-product plants. And although it is common to associate this type of plant with CMOs (Contract Manufacturing Organizations), there are also pharmaceutical companies that choose to build multi-product plants.
Faced with a diversified portfolio and such a changing market, flexibility is a great tool for managing risk.
Some of the elements that contribute to uncertainty about the decision to build or not a new plant are:
- Variations in demand for a product
- Appearance of competing drugs
- Changes to increase process efficiency
- Prioritization between products of the same portfolio
Cross contamination
It is almost inevitable to think of multi-product plants and that a red light does not go on in the head of an engineer who says: “Risk of cross contamination”. Therein lies the main challenge of this type of plant.
The fact of having different processes in the same non-segregated space carries the risk that a product x ends up contaminating another product y. This implies a risk for the safety of patients and the quality of medicines.
These risks can be mitigated by implementing a good cross-contamination control strategy. For this, the following must be taken into account:
- plant processes
- the potency and toxicology of the different products
- the actions to have risk levels that do not compromise the efficacy and safety of the product
Both the EMA and the FDA have documents with directives and recommendations to limit the risks of cross-contamination.
- EMA: ICH Q8, Q9, Q10
- FDA: 21 CFR 600.11
- ISPE: Risk-Based Manufacture of Pharma Products
Additionally, the cleanup strategy and cleanup validation becomes even more critical. Quantifiable limits must be established on the amount of contaminants that can be “accepted” after cleaning to continue with the next production batch.
There are limits to the multi-product concept
The fact of being able to use multi-product plants is a resource that the biopharmaceutical industry must take advantage of. But there is a limit to what can and cannot be done. This limit is imposed by the state of the containment technology of pharmaceutical equipment (in addition to other factors that provide flexibility. Of course, as this technology advances, more combinations will become possible.
When starting a project it is important to be clear about the products to be produced, their toxicological characteristics and the process. Using these elements and a good feasibility study, we can conclude if:
- an idea is possible or not (at the multi-product plant level)
- it makes “economic sense”.v Gaining flexibility often means compromising efficiency. A good balance must be made between these two features, to conclude if a project makes sense or not.
- limit project uncertainty
Containment starts in design
Avoiding cross contamination starts at the design phase of the plant. A good design allows to minimize the risk of cross contamination, increase flexibility, facilitate the operation of the plant and reduce production costs.
A good level of definition in the early phases of the project means that the design offers great advantages to the multi-product plant. Experience, knowledge of cGMP and expertise in pharmaceutical processes / bioprocesses are key. That is why Klinea, as an engineering company specialized in the biopharmaceutical sector, is a trusted partner for the design of multi-product plants.
If you are interested in learning more about multi-product plants and how we can help you, contact us: klinea@klinea.es
