Case Study: Assessing Biologics Manufacturing Needs
DETERMINING THE RIGHT TYPE OF BIOMANUFACTURING CAPACITY
Seven of the top ten drugs on the market are biologics. And, an explosion in the number in development pipelines means demand for manufacturing capacity is still increasing.
As an industry, we have manufacturing capacity, but the question is whether it is the right capacity. The biologics in development today are typically high value, niche drugs. These require the production of larger numbers of smaller batches compared to the previous generation of blockbuster drugs, which are produced in lower numbers of much larger batches.
To meet the increased demand for biomanufacturing capacity, you can build in-house or outsource. In terms of the type of capacity, the options are stainless steel, single-use, or a hybrid solution that combines the two.
Single-use systems are more suitable for smaller scale, more potent molecules, and also enable facilities to more easily adopt a multi-product approach. It is essential to choose a manufacturing strategy with the flexibility to produce these products, supporting your needs today and into the future.
Do you have data to validate your decision?
“Decision-making always needs to be supported by relevant data” Nick Martin, Head of Operations
4 key considerations when determining the right type of biomanufacturing capacity:
1. Understand the industry needs now and going forward
Whether keeping capacity in-house or outsourcing production, it is important to fully understand your needs, your customers’ needs, or both. This will help identify all the criteria that can inform the type of manufacturing capacity you commission.
For example, you may want to serve additional or multiple markets globally, and therefore need to establish or access capacity that meets the corresponding local, regional, or international regulatory requirements. There are also the factors of speed and cost. With increasing budget constraints, how can you add capacity in the most cost-effective, efficient, and risk-mitigated way?
Fujifilm Diosynth is a contract development and manufacturing organization (CDMO) that was faced with this challenge. They were seeing considerable demand from their global customers for cGMP contract manufacturing based on mammalian cell culture technologies and needed to add additional capacity to support this. They spoke to customers to understand how they could best support them on their clinical journey.
These discussions informed the need for a practical solution that would allow Fujifilm Diosynth to quickly turn around larger numbers of smaller batches. They developed a short term objective of adding smart capacity for faster turnaround times and then, longer term, having the option to add the right additional capacity as their customers’ needs grew.
2. Analyze and build on your existing capacity
For any company with existing capacity, it is important to examine what is working well for your customers and your business.
This investigation might lead you to capitalize on what you already have, and expand or duplicate this capacity. In other cases, it might make more sense to develop complementary capacity to add value to your business’s offering.
At Fujifilm Diosynth, they wanted to expand their UK capabilities and were looking to develop the right capacity with an accelerated timeline. They also needed that capacity sooner rather than later. The typical multi-year timescales for stainless steel or hybrid options would have taken too long to bring online.
Fujifilm Diosynth was already a successful early adopter of single-use technologies at their site in Research Triangle Park, North Carolina, namely GE Healthcare’s BioProcess Xcellerex platform. They used the experience from that platform to inform an analysis of what would be the fastest solution to add capacity in the UK.
One of the advantages of single-use technology is that when using the same technology platform, you can duplicate capacity at another site and this can be an exact copy. You can also use the learnings from one location to support another, to enable a smoother technology transfer process and a more rapid duplication of capacity.
3. Inform and validate your decision with the right data
When commissioning new biomanufacturing capacity, your decision should be informed by relevant data. Once you have identified the set of criteria that the new capacity must meet, it is important to compare different types of technology and platforms to see which best supports your business needs.
There are tools available to help you determine the right solution. Process design tools can map your biomanufacturing process workflow to determine the best choice of hardware, software, and layout.
You can also develop your process science database. This involves determining the science-based process information required to give you the confidence to design a robust process that can also be scalable. You can then move on to determine the right equipment for the process and a facility design that supports the process workflow.
In addition, you can run physical comparative studies with different equipment, assessing against your pre-determined set of criteria. This allows you to make a direct comparison not just of the production output and quality, but also costs, speed, volume capacity, and efficiency.
In undertaking this final option, Fujifilm Diosynth compared CHO mAb runs on a 110L stainless steel bioreactor with an Xcellerex 200L bioreactor. Using the data from those runs, they found that single-use was the fastest and most cost-effective solution for getting a capability online at their Billingham, UK, site, and to start delivering to customers.
In many cases, a company will require biomanufacturing capacity that is suitable for a diverse portfolio of multiple products. The new capacity will need to be flexible enough to support biologics manufacturing needs today, and support the unknown needs of tomorrow, in a rapid and cost-effective manner.
Fujifilm Diosynth, a CDMO supporting many different biopharmaceutical organizations around the globe, wanted to quickly add duplicate capacity to support mammalian cell-based biomanufacturing.
Single-use has the flexibility to enable the rapid delivery of many small batches. Essentially, the reaction vessel is the bag, so time and money is not wasted in cleaning the equipment in between batches. In addition, you can easily and rapidly add bioreactors to the process workflow as biomanufacturing demands increase.
Weighing up the options, Fujifilm Diosynth decided to replicate their North Carolina, USA, single-use capacity at their Billingham, UK, site because they found GE Healthcare’s BioProcess single-use platform gave them the flexibility to build on their existing processes. Working in collaboration with GE, they achieved rapid technology transfer and qualification of their UK single-use facility – and were able to implement the UK’s first cGMP single-use manufacturing facility in just 14 months.
In selecting the right biomanufacturing platform, you need to fully understand what the industry needs are and which parts of the drug development life cycle you intend to support with your new capacity. You need to have rigorous selection and assessment criteria, validated with relevant data, to select the single-use platform that has the flexibility to suit your biomanufacturing needs today and going forward.
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