LFT Manufacturing23 Sep 2020 17:08
There is a lot of people talking about the tests and validation here. We are can see one massive market. I work in manufacturing sector and have multiple access in to medical device manufacturing businesses. For Avacta the test is made up of three key components.
1. The Affimer combination made and produced by Avacta and this is the critical bit! It determines the sensitivity and specivity of the test.
2. The membrane technology which comes from Cytiva which is very specialised hence there key involvement
3. The casing - this is an injection moulded component made of polymer, usually chosen to match the test use.
The first two are specialist technologies which are already covered. The third sounds easy. But this is a critical part and needs specialist tooling. The moulded part will come from a multi cavity tool with usually 8, 16, 32 or 48 cavities. The tool would be split into a male and female part (front and back if you like). The tooling for such projects is typically in the cost range of £400K to £600K per tool. One tool could potentially run at 360 cycles per hour. If we take a 16 + 16 tool (32 cavities) then you would produce 5760 pairs per hour or 138,240 per day. A moulding machine to run that tool, costs with equipment around it around £350K per machine. There are already multiple manufacturers who will be making these parts for existing lateral flow diagnostic testing. But, the challenge is increasing the number of machines and tooling. This is a key area and the sub-suppliers will be to companies like BBI and Abingdon Health. The question for these manufacturers is after the investment how long will this product be required and who is funding these projects. To make 10 million tests per week, you would need 72 sets of machines and tools in multiple suppliers.
You can be sure there will be multiple companies building capacity to do just this. Part of the time frame here is the lead-times of specific tooling which can be up to 16 weeks. Only Avacta, BBI and Abingdon know how big there current supply chain is to fulfil the huge demand required for all the current projects. These details are very important to understand in the current situation. The tools can be made from a number of high quality tool makers around the world, so you can be sure that everything is being done to ensure they have capacity to expand. I think any delays being seen are most likely due to this capacity requirement. Avacta will need based on the target S&S requirements millions of test per day to meet demand and once the product is not only out there but showing it can be relied on in the field a huge ramp up.
The UK market alone is currently off the scale, let alone the needs across the whole planet.
This hopefully helps people understand better the full picture of just the cases for LFT.
Cheers, Rich