Bioproduction

The success of this process relies on the conditions of many factors, such as the cell line, the cell culture media, and the bioreactor configuration. If any of these aspects are disrupted, consistent yielding becomes particularly challenging, as this process requires continuity and stability of physico-chemical factors such as pH conditions or osmotic pressure, in order to maintain performance goals.

Scaling up still remains a challenging task, requiring the selection and optimisation of the right parameters, as well as finding the tailored mix of components, improving the stability of the resulting biomolecules.

Lastly, it involves the use of living organisms, which can raise concerns about safety. One of the primary risks is contamination during the manufacturing by harmful microbial strains, viruses, or other pathogens that can affect the quality and safety of the final product. Bioproducts can also contain impurities, such as host cell proteins, DNA and endotoxins.

What are the technological limitations of biomanufacturing and what are the developing solutions to break them? What are the latest innovations? What are the key criteria to consider when choosing a system?

As these technologies are evolving, and unexpected issues will undoubtedly occur when trying to scale-up the slightest improvement, the make or buy question is a prominent one in biomanufacturing. It is reinforced by a relative lack of talents in the space, or at least a limited number of experienced professionals to be hired, the high capex needed to set up a new facility, and ultimately the scale effect.

The freedom to operate is also to take into account as the field is well covered with a lot of patents, protecting cell lines, technologies, processes and their monitoring tools, etc.

Numerous companies across the globe are offering bioproduction services today (Contract Manufacturing Organizations): different systems, either proprietary or not, different bioreactor sizes, different quality grades (e.g. GMP/GRAS or not), … The supply and demand market has struggled to stabilize for decades, with peaks of over- and under-capacities.

What are the key criteria to consider when choosing a partner? How to secure bioproduction supply? How to ensure strategic autonomy?

Bioproducts often involve genetically modified organisms, whether they are micro-organisms, insects, plants or animals sometimes. This may raise ethical concerns related to the use of animals in particular, such as transgenic animals, and broadly, the use of living organisms for commercial purposes, and the long-term effects of such modifications.

The environmental impact should be very dependent on the bioproduction system itself, more specifically on the consumables and the waste, and on the bioproduct usage. It is still to be assessed on case-by-case basis, so the conceptual sustainability of industrial bioprocessing remains uncertain.

How to assess the concrete environmental impact of a given bioproduction? Because biomanufacturing is all about optimization, how can we optimize the environmental impact of a given bioproduct?

The regulatory environment around this process is still evolving, with the rise of numerous regulations and guidelines governing this sector. For instance, handling and disposal of biologics are important regulatory aspects to ensure safety and minimize environmental impact. Compliance with these regulations is essential for obtaining approval for the commercialization of these products. However, ensuring such compliance can be challenging and requires strict quality control measures.

How do manufacturing procedures align with local markets regulations? What kinds of regulatory challenges will the industry face in the future?