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Articles Taking an assay from R&D through to routine production
Posted: April 16, 2018
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Technical transfer is the process that a product moves from R&D to high volume manufacturing. The product will then have all validations and documentation I'm place.

It has 2 key parts

Manufacturing process itself
Documentation (quality)

Generation of manufacturing batches
Initially 3 batches of increasing size are produced. For example 50 metres of membrane for batch 1, 100 metres for the second batch and 200 meters for the third

This reduces the risk by ensuring reproducibility and robustness on an increasing scale, while also validating the processes employed in manufacture.

Documentation is required by both quality and regulatory standards. A typical manufactured product may have over 80 documents associated with its manufacture.

This confirms processes and procedures are able to cope with the rigours of high throughput lateral flow manufacturing.

An additional key objective of the technical transfer process, from both a quality and regulatory point-of-view, is to ensure all staff involved in the production process, both primary production (materials preparation) and secondary production (assembly and final packaging) are fully trained in the processes involved for each specific product.

Devices generated during technical transfer are frequently used for stability and shipping studies and also for field trials.

Lol. Snao, snap, snap

Pete - can I check in the nicest way possible you know how to do a percentage calculation.

I'm thinking you could be down 2p on a price of 5p at most. That isn't 84%.

I top up not far from that. Like lots of investment I'm thinking patience is going to help

Tank you alchemyst

16p and £1.87 here. Chill. It will be right

Maybe COPD data already priced in?

Snap

Most kitchens have similar types of equipment especially if they are all dedicated to producing a similar dish - let's say waffles.

They would probably use a similar basic recipe and the people employed would be waffle experts.

When someone invents a new waffle but lacks capacity for a huge increase in demand for the new waffle then they might approach dedicated waffle makers.

However, they need to make sure every single waffle is exactly the same - this is not helped by the fact that a key new ingredient has never been produced in such quantities before and its processing involves manipulation with a very specific other ingredient.

Who knows how they could overcome this. I'm fairly confident that they will.

Roundhowe - you mentioned it was rumoured and then described something 90% of which is in public domain. The only bit that isn't was they are producing for Avacta but then clam up when asked to expand. It was great to bring in discission of CAR so thank you but more so the other posters who put some meat on the bones.

I'm not sure the waffly versatile was aimed at anyone in particular but did seem to ring true with other people here

What Monkshood said...

Yep - so if the new kit they are making is enough to warrant mention (and x2 in SP), they must have received orders. So someone, somewhere needs kit......

Moray Eels are a type of sea snake ?

Im thinking Pharma Giles is in the wrong kitchen.

And Spike - I'm taking Spike. I'm just a boy. I'm too young to die

Following this mornings healthy debate about waffle making in someone elses kitchen got me thinking.

Who amongst us would be any use on a dessert island (see what I did there). I'm choosing DOH and PAH with Mr ST and Wilson as reserves.

PAH. Me too - its either that or cut the grass.

Well going back to the original analogy I now how my soufflé in the oven - its only half baked at the moment.

I want to open the oven but....

Awhile back it was mentioned that Avacta were embarking on some iso type stuff - quality standards or something. These might (or might not) impact on the components. In pharma it could be considered to be an audit and delivered CAPA on your API - you couldn't start shipping it (possibly even for trials) without that in place - why test something only for it to be changed and have to retest.

I'm guessing that the hold up is with Avacta securing these standards. Its a total guess and made up waffle but I didn't want to be left out.

Are LFD considered pharma?