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Key Considerations for Microbial Fermentation Success in Bioproduction

Scientist in sterile lab attire operating a stainless steel bioreactor for microbial fermentation
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The bioproduction of biologics such as plasmids and enzymes is crucial for the development of biopharmaceuticals like cutting-edge gene therapies. However, scaling microbial fermentation from the lab bench to manufacture can be challenging, particularly against an evolving regulatory backdrop.


While some biopharmaceutical companies opt to take on these challenges themselves, a Contract Development and Manufacturing Organisation (CDMO) can help support drug development from pre-clinical to commercial scale.


Technology Networks spoke to Louise Digby, vice president of enzymes and bioproduction at BioProduction by SEKISUI, to discuss some of the current challenges in scaling microbial fermentation and how SEKISUI is leveraging its expertise as a fermentation-focused CDMO to help pharmaceutical companies bring life-saving therapies to market. 

Blake Forman (BF):

What are the most pressing challenges in scaling microbial fermentation for biopharmaceutical production, and how does Bioproduction by SEKISUI approach these challenges?


Louise Digby (LD):

When we take on client projects, scale-up is often what we're asked to do, sometimes we transfer a process on the same scale, but scale-up is often a feature. There are two key success factors in achieving a successful scale-up within microbial fermentation, especially in upstream bioprocesses. One factor is being able to do robust feasibility studies to optimize the process. At SEKISUI, we conduct feasibility studies with the full scale in mind, and that's key. At bench scale in the lab, you can apply many different levers, but unless you can replicate those at scale, those studies aren't of any use.


We design our feasibility studies with the production scale in mind, so we know what constraints are present at the full scale that may not be obvious at the lab scale.


The second critical success factor is around equipment choices. We aim to have our small-scale equipment aligned with the large-scale so that you're not changing the nature of the equipment as you scale up. In the case of our new Good Manufacturing Practices (GMP) facility, for which construction has just completed in Kent, UK we can accommodate production scales of up to 1000 liters. But in the lab, we're starting with many fermenters on much smaller scales, so we try to set the way we use those fermenters in the development lab to align with what we know is reproducible at the scale we are going up to.



BF:
How does BioProduction by SEKISUI leverage microbial fermentation to address the demand for enzymes in emerging therapeutic areas, such as cell and gene therapy?

LD:

Our capabilities align with many segments within the biopharmaceutical sector, such as in enzyme, protein therapy or antibody fragment-based therapy production. Within the cell and gene therapy sector, the area we're closest aligned with is the needs of the gene therapy sector. Within gene therapy there are many enzymes needed in the production processes, and microbial fermentation-based processes are quite well suited to producing those enzymes. An area where we're focused on trying to develop our capabilities is in producing the enzymes that are needed for those gene therapy technologies to the right level of purity and quality.

Another area our capabilities align with is plasmid production. We have historically done some plasmid production projects, not so much recently, but we do believe that our skills and capability in the microbial fermentation space are well suited to serving the needs of that market. Plasmids are key to many sectors, including things like adeno-associated virus production. That's a key area of growth that we're seeing right now.



BF:
When you see new modalities coming to the forefront of research efforts, how easy is it to adapt to this? Are there any barriers that make this difficult?

LD:

On the regulatory side it's a constantly evolving picture. Microbial-based biologic production is subject to licensing and certification and the regulations are constantly evolving. One of the challenges is staying up to speed with the expectations of the regulator in terms of how they expect us to apply and satisfy those regulations.


Aside from regulatory changes, the technical solutions available are also constantly evolving. One of the things we are keen on is ensuring that we are up to date on what technologies are available, both in the analytical space and the equipment space. We always want to ensure our knowledge base stays in line with the approaches being taken at the bench scale when new modalities are being developed. 



BF:
SEKISUI has recently completed a £15.7 million expansion in its cGMP biopharma CDMO capacity. How will this expansion support SEKISUI’s mission and goals?

LD:
SEKISUI is a very diversified corporation. Within that corporation, life sciences are a key focus for growth, and within the life sciences sector, the focus for growth is equally focused on pharma services and diagnostics. This is where this investment in our UK facilities is strategic because it plays into our ambitions in growing our pharma services business globally. This investment in biologics production for the pharma sector, in terms of GMP-based production, is critical to our overarching strategy to grow our pharma services business globally, both in Japan, but also internationally.


BF:
Sustainability is a growing concern across all industries, could you elaborate on SEKISUI's initiatives to minimize environmental impact?

LD:
Environmental, Social, and Governance (ESG) is a strategic priority for us at a corporate level, and that shows in our focus here in the Kent facility too. This manifests itself in many ways. Environmental stewardship is important to us. We also, across most of our sites, seek to achieve the necessary environmental certification under ISO. We have also enrolled in the EcoVadis program to be able to show environmental credentials and put them to the test in a way that is aligned with industry standards. Several years in a row, we've achieved silver status within EcoVadis, and that's something we are focused on maintaining and hopefully improving on. 


BF:
Looking ahead, what do you see as the next big opportunity for the biopharmaceutical industry, and how is SEKISUI positioning itself to lead in this space?

LD:
Our goal is always to align ourselves with where we see growth and investment in the biopharma sector, and the investment growth we're seeing in the gene therapy sector is something we're tracking very closely. Aside from that, the other sector that we're keeping a keen eye on is the immunotherapy sector, which is also a high-growth area. Historically, the immunotherapy sector has been a key driver behind mammalian-based production, which is not our focus area in Kent, but we now see much more interest growing in the production of antibody fragments, which can be produced microbially.