7.5

CONCLUDING REMARKS

The progressive higher demand for prophylactic and therapeutic vaccines in the last

decades is pressuring the biotechnological industry to accelerate the process devel-

opment phase. There is a real need to develop purification processes with higher

productivity and robustness, to address the challenges related to the biological di-

versity of the viral-based vaccine candidates under development. The current

commercial-scale manufacture of biological products is performed in batch processes.

Although the batch operation promotes an easier design, optimization of the unit

operations and off-line quality control of the target product, the DSP at a research

level is focusing to develop continuous processes. The adoption of continuous bio-

processing is expected to relieve the economic and regulatory challenges that are

being faced in the biopharmaceutical industry [83]. Allied to this, high throughput

process development (HTPD) has evolved to include both upstream and downstream

development, and big biopharma companies are using such an approach in their

process development. Regarding downstream processing, efforts are being made to

allow better purification processes with the development of new and improved ma-

terials as well as new operating modes. In the case of manufacturing facilities, the

tendency is for the adoption of a multimodal type that allows a flexible approach,

capable of accommodating several processes. This means less risk to the companies,

either if the final product is still waiting for approval or the emergence of competitors.

However, a multimodal facility brings other challenges, like the requirement of a

flexible operator team, having to learn numerous different processes, a higher prob-

ability of cross-contamination, and more complex supply chains.

Overall, the current trends in the biopharmaceutical industry, especially in the

vaccines field, are driving the implementation of high-capacity processes that en-

able the reducing costs and equipment footprint but always prioritizing the process

efficiency and product quality.

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Downstream processing

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