ok - I'm going to leave the children to play for the weekend. Anyone who want to gain some real insight into the framework within which Avacta are operating might want to peruse ISO13485. This is just a tiny fraction of the regulatory burden they are wearing:
see you monday (perhaps)
On reflection @Travel_Light forget my last post and try this instead:
With recognition and admiration of Colonel Nathan R Jessup: ( and tongue firmly in cheek)
You cant handle the truth! Son we live in a world that has diseases, and those have to be remedied by scientists with brains. Whose gonna do it you, you raucous drifter? I had a greater responsibility than you can possibly fathom. You whinge at delays, and you curse the scientists as slow. You have that luxury, you have the luxury of not knowing what I know, that drug product development while methodical, saves lives. And my existence while grotesque and incomprehensible, to you, saved lives. You don't want the truth because deep down in places you don’t talk about parties; you want me developing those medicines, you need me making those medicines! We use words like system, process, stability, We use these words as the backbone of a development lifecycle, you use them as a punch line. I have neither the time, or the inclination, to explain myself to a man, who rises and sleeps under the blanket of the very information and insights that I provide, and then questions the manner, in which I provide them. I'd rather you just say 'thank you' and go on your way. Otherwise I suggest you pick up a degree or two, 30 years experience and go do it yourself. Either way, I don't give a damn, what you think !
(meant in jest) Ophidian
7. Additional batches made again at pilot scale to clinical standards for first time clinical evaluation. Supplied Wk1/Wk2 Aug Happening Now - Time to complete clinical Validation ~21 Days
8. In parallel with clinical programme; Scale up to production scale. Include Tech transfer and validation batches (again put on stability to generate data) Happening Now
Not really sure how much more clearly I could have said it. If Alastair had had my timeline in front of him and was reading off it it couldn't have been any more clear.
As a reminder - I gave you these steps, including which were in parallel back in early June. Now whilst the timing may have slipped slightly, other than including an extra step as 6b to explain the additional process step and hence the delay I'm not sure I could have got it any better.
Of course those drifting raucously through who think they are better and more clever will I'm sure seek to deride and criticise. I didn't post this up for my benefit - I know it. I posted it to try and illuminate for others.
So I guess @Travel_Light you can interpret what Avacta said anyway you like and either seek to reconcile or not with the outline I've shared for you - your choice.
Trek - assuming you mean the affimers (not antigens) - As far as I know, all affimers are being made by Avacta so there should be good controls on the manufacturing process. There will also be a specification of course. Now - what I don't know is whether or not affimers are made by a batch process or in fact are from a continuous process (just harvesting as they go along) would actually be interesting to know. In the case of a drug substance each batch is "released" by a competent person based on testing against the release spec. Their is also a review nowadays of the data generated during manufacture captured against key parameters - things like (and I'm just giving examples here as I'm not familiar with the manufacturing process) - vat temperature, flow rates, mixer speeds, etc etc.
There is an aim in most manufacturing systems to get to parametric release - that is to say if you have identified all the key parameters that can effect the product, have defined acceptable ranges and have then monitored in real time all of those parameters then is everything is within the limits your batch must pass. Rarely however is there not some kind of end testing for release.
Hope this helps
Trek - that work is not part of the clinical validation. It will have been done and proved months ago (in the lab) at the very earliest stages of selecting which of the 50+ affimers Avacta created were the most specific. By the time it got on the strip - it's a given.
@Alltorque - the Analytical validation doesn't establish the clinical Sensitivity and clinical selectivity.
The confusion is that the terms whilst the same mean completely different things. These definitions straight out of the MHRA TPP:
Sensitivity of a measurement procedure. Quotient of the change in a measurement indication and the corresponding change in a value of a quantity being measured
Selectivity of a measurement procedure capability of a measuring system, using a specified measurement procedure, to provide measurement results for one or more measurands which do not depend on each other nor on any other quantity in the system undergoing measurement.
Clinical (Diagnostic) Sensitivity
Ability of an IVD examination procedure to identify the presence of a target marker associated with a particular disease or condition
Clinical (Diagnostic) Specificity
Ability of an IVD examination procedure to recognise the absence of a target marker associated with a particular disease or condition
The above definitions of performance characterisitics taken from BS EN ISO 18113-1:2011, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling): Terms, definitions and general requirements.
Hope this helps
" we are expanding the protein production facilities in order to meet the expected demand for Affimer proteins for the COVID-19 tests and future diagnostic tests in the pipeline. "
I missed this little gem on first reading. I wonder if there is a Flu test in the works ? Put it on the same strip and you have the perfect test ??
Even as a separate LFD it would have a market but as a combo LFD - invaluable through the winter flue season.
just as a reminder - the "Timeline" was originally posted not as an attempt to predict "D-day" but as a demonstration of the complexity of the tasks and how paralleling some of them up could work. Sure - and end point gives some level of insight but it is more about the process which I think RNS after RNS and company presentations have now demonstrated to have been almost 100% spot on. When exactly these things happen is fuzzy what HAS to happen and how they can be ordered and their interdependencies is for me what counts as helping indicate probable progress. Sure I got the longer than expected optimisation period quite wrong but I also think I have identified why and what caused it. (I also think it was 100% out of Avactas hands - I think Cytiva dropped the ball by following US thinking not UK/EU) and had to bsically re-do a stage of development over).
it's an antibody test
@wyndrum - some institutions have in house rules about the size (in £) of a holding. Maybe they have to off load some. Others are just machines taking their 5% and moving on. Mostly they are not investors they are money as a commodity churners. Truthfully - I don't know but my information is that there has been a seller and that it is practically done now.