Employing Innovative Approaches, Technological Advancements and Collaborative Strategies to Address Industry Challenges
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Sharmilee Patel, Head of Business Development at Oxford Biomedica, discusses industry challenges such as cost of goods and talent acquisition, emphasizing the importance of construct design and engineering. Sharmilee goes on to highlight the role of automation in addressing labor-intensive processes, and the significance of anticipating challenges early for successful tech transfers and advanced therapy development.
To start with, please could you introduce yourself?
I’m Sharmilee Patel, I’m the Head of Business Development for the US East Coast for Oxford Biomedica. I have been with the company for 2 ½ years and have been in the industry since 2000. Over 20 of those years I’ve spent at CDMOs focusing on biologics, cell therapy, tissue therapy, and gene therapy manufacturing services.
What are the specific challenges your customers are currently facing in the advanced therapies field?
I attended the JPMorgan conference last week and Tim Hunt, CEO of the Alliance for Regenerative Medicine (ARM), actually talked about the analysis that ARM had done where gene therapies, they’re tackling devastating diseases that are very expensive [to treat], and they did an analysis looking at the overall healthcare costs that these patients have versus the gene therapy costs, and you can tell that they’re clearly affordable.
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Peter Marks, the Head of FDA, actually hit the nail on the head when he said the cell therapy manufacturers need to really look at streamlining the cost of manufacturing over the next 10 years because if not, these cell therapies and gene therapies are going to be increasingly inaccessible to the patients that rely on them.
I would say the biggest challenge is cost of goods. The other challenge is talent – attracting and retaining the right talent is paramount. Then with the industry, the way we’re heading, at least from the investor’s perspective, they’re being very strategic. So for the emerging pharmas, speed to proof-of-concept is paramount.
Can you explain how focusing on construct design and engineering can directly address challenges faced by late-stage programs, and what tangible improvements can be expected as a result of this focus?
So, construct and plasmid engineering and design is the key to making sure that you have the optimal quality of product as well as optimal titer.
We have a dual plasmid system that has consistently shown to improve the product quality as well as product titer over the traditional triple-transfection system.
For lenti-viral vectors, we have the third-generation vector system which has already been commercialized. We also just launched the TetraVecta™ system last year, and that has four building blocks with that. Depending on the type of construct and the length of the construct, you can determine what aspects of the four building blocks you want to build into that vector system.
The other thing we have is also packaging cell lines and producer cell lines, which some of our customers are currently evaluating, and all of these combined, at least with the TetraVecta, packaging and producer cell lines, we are seeing improved safety features with them, higher quality, and they’re also increasing the packaging capacity.
How can technological advancements directly tackle challenges faced by partners, and can you share specific examples of how automation has proven to be a practical solution?
Analytics, especially cell-based analytics, are very labor-intensive. They require a specific skill set – you want to be able to repeatedly pipette in the same manner over and over. This causes ergonomic concerns, it also causes employee burnout, you’re introducing pipetting-related human error.
What automation does is it has increased throughput – the robots do not get tired – we also do not have to limit the sample sizes. It has eliminated pipetting-related human error, and as a result, that has really helped us significantly.
When it comes to specific examples, we have now brought RCL co-culture assay, as well as integration titer assay – both are fully automated and are used in our quality control labs – and then we also have semi-automated vector genome titer assay, which is also now implemented in quality control labs.
What are some of the typical challenges associated with tech transfer, and how can these be mitigated?
We tech transfer customer programs. For example, the COVID vaccine that we tech transferred in, that is a good example of a program that we did tech transfer in. We optimized it or scaled it up and produced over 100 million doses of it now.
With tech transfers for any products coming in, we have to do a safety assessment. The challenges that tech transfer has is that the receiving site may not have the exact same equipment, analytics, raw materials, components established, and so at Oxford Biomedica, we do a gap analysis. We utilize a gap analysis tool and understand what those gaps are. Based on the gaps identified, our team puts together a mitigation plan, and this mitigation plan is mutually agreed.
Our first attempt is to use already existing equipment at Oxford Biomedica so that we can save on timelines. So, “can we adapt that?”
Analytics, when possible, we’ll try to adapt our platform analytics as well as compendial analytics. If we need to, we can tech transfer analytics as well. In fact, even for our established platforms, certain specific program-specific analytics are still tech transferred in.
Do you have any final thoughts or comments you would like to share?
For final comments, I would like customers to think about anticipating what’s coming next. Oftentimes, these advanced therapies, cell and gene therapies, they’re highly effective and they catapult from Phase I into pivotal trials, and what happens is that sometimes when you have chosen speed over making sure that your process is right, that becomes very challenging when it comes to manufacturing, especially when it comes to potency assays. I have seen a number of programs where potency assays either delays a program or it gets on the critical path.
So, think about long term and think about mitigations earlier rather than later.
This interview has been produced in partnership with Oxford Biomedica.