Paradigmers, in a striving for excellence and pushing that top class envelope just a fraction further, tonight I present a combination of some of the old format mixed with some of the new. Not sure if this will be a regular increase in standard as it does require some effort. But for now, please do enjoy this presentation.
NOTE
This is a super long one, so long that I need to break it up into two parts otherwise you will all fall asleep half way through. So I suggest getting comfortable, a glass of red, a morning coffee? Perhaps popcorn or a few crackers and cheese!?
Let's first cover off the agenda for Part 1:
BACK STORY
I just bought a small vacuum cleaner the other day, I needed one just to do a small one bed apartment. Now I've had a few different vacuum cleaners over the years. I had a little red hoover that I started off with, it was ok...then I rented in a smallish 3 bedroom town house that had ducted vacuuming and it was very effective. My current place of abode also has ducted vacuuming and its ok but it could be better, certainly not quite as powerful as the previous place. Just the other day I bought a Miele, made in Germany. It's the best ever for a compact vacuum, amazing power but light weight, great unit.
German made...a good standard for sure.
When we moved into our current house I had just one appliance requirement that was a must and of my choice, the dishwasher and I wanted it to also be a Miele manufactured in Germany. They had tested this type of unit for some 20 years daily without fault. My wife chose the fridge and after quite some deliberation she chose a Liehbherr, also made in Germany and guess what, the washing machine we bought is a Bosch...no need to say where that one is made, Germany.The Germans are very well known for their quality and attention to detail...They are world renown for their workmanship and pride themselves in delivering top products that last.
Mozz, love your stories and I'm actually surprisingly happy for you and your appliances....but can you please tell us how AT ALL IS THIS RELEVANT to MY holding in PAR? Paradigmers, Dear Paradigmers...quite simply, our iPPS product is also made in Germany.
A BIT 'BOUT BENE
Who is Bene? Well most of you know our product is made by another company called Bene founded in Germany in 1947. I'm sure there will be some new investors to us that don't know this relationship and that we ourselves (PAR) do not manufacture the actual product. We are are the licensed company that has done and doing the trials and we will be able to eventually sell the product once we get certification via such bodies as the FDA, EMA and TGA. Yes we will have to give Bene a royalty but in no way is it onerous, an estimated 2% per sale, Bene currently already have the GMP (see part 2 in the next post) and have FDA approval for a pill format version of the drug used mainly for treatment of bladder diseases. In the pill format the drug is known as Elmiron and is a totally different MOA in this format, hence the need for clinical trials for the new indications of the repurposed drug, this is where we come into the picture.
FROM BARK TO BATCH
Well that should prob read from Bark to Bene to Batch! Most of you reading this would know that PPS itself is a direct derivative of a bark from a tree called Beechwood.
What? Life changer? This bark? You bet!
Bene have been in business as most of you know, for not year, but decades. This years it's their 73rd birthday. FiftyOne Capital had the good fortune of visited them and their account was in a word, outstanding. The tech they have employed, the quality...well it has to be, it's FDA approved. The FDA don't approve such manufacturing of critical drugs lightly.
Paradigmers, this is not just a case of slicing off some bark from a random tree, carting it to a warehouse, smashing it up and adding a few ingredients from the nearby supermarket, boiling it all up and sending it out. This is a very very complex and precise process to extract, sulphatise via esterification (See Appendix A) of xylopyranose hydroxyl groups and deliver the perfect and exact molecule each and every time. It's about a 150 precise step process involving some sub steps such as heating (denaturing and depolymerisation of some amount of proteins), filtering at various stages, using a centrifuge for separation and purification steps. There would also be Sulphation processes and further purification steps after that step.
To get our concentration just perfect, there would be steps to adjust the molecular weight of the final substrate. (Examples of this step may include one or more in combination of the following: acid treatment, alkali treatment, enzyme treatment, NF membrane treatment, UF membrane treatment, RO membrane treatment, gel filtration treatment, activated carbon treatment, ion exchange treatment, electrodialysis treatment). Ok I know there are a couple of you chemists out there that are curious, take a look at Reference 3 in the Reference section below at the end of this post for more (Juicy?) detail about a possible way to make PPS. Consistency at a molecular level at 100% purity? ...and not just a few batches but in soon to be MILLIONS at mass scale? If anyone is up for such a challenge, it's Bene.
A QUALITY STANDARD
Who here have heard of the ISO 9000 series of standards?Do you know what that means? The ISO is one of the highest standards and guess who has this designation in manufacturing? Yes our very own manufacturing partners, Bene. As a side story, within this ISO standard there is a concept called Six Sigma. Very few companies hold this amazing title, two that I know of are GE (think aircraft and jet engine manufacturing) and the Tiffinwallah system in Mumbai. 1
Briefly the Tiffinwallah system is an elaborate manual way of getting your home cooked meal from home to the office. Think of it like a courier system but instead of it being a within two day or overnight delivery system, it's within 4 hours. So your partner at home cooks your meal in the morning, by 11am its sent via a pickup service (one of 5000 employees), and after just a few hours your partner has it in the office all piping hot in a standardised lunchbox. Of the 175,000 people that use this system daily in the city of Mumbai, over some 16 million transactions that occur over the months, how many of these go wrong? Yep...ONE. One error in 16 million. Now if that ain't quality...I'm not sure what could be.
Ok back to our story.So Bene have an ISO 9000 certification. In Part 2 we will take just a sampling of the detail required to get GMP certification and we will then understand more of what our business partner actually will do soon to get our valued product out to the wide world.
APPENDIX A - ESTERIFICATION
Esterification is a chemical reaction that forms at least one ester (a type of compound produced by reaction between acids and alcohols). This forms an important step in the manufacture of drugs.
Above, simplified version in a lab....on a commercial scale it would involve a lot!
(20min delay)