Looking Beyond the Obvious

Galenisys Newsletter : June 2026

Table of Contents

• TALES FROM FARAWAY PHARMA
  “IT'S NOT IN THE SPECIFICATION”
  By Steve Biddulph

• FOR THE HANTAVIRUS IT WAS A PUBLIC RELATIONS DISASTER
  A sideways look at advice to aspiring viruses.
  By Tony Dunford

• VARIOUS EPIDEMICS
  They come in many forms
  By Tony Dunford

• Folks who've called us recently

TALES FROM FARAWAY PHARMA

by Steve Biddulph

Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.

“IT'S NOT IN THE SPECIFICATION”
“Yes it is……….No it isn't”

The company I was working for had a client in the Far East who wished to market locally our successful formulation for “upset stomach”.
Together with the client we’d prepared a very detailed specification which both parties approved & signed. The specification covered physico-chemical analyses, microbiological assessments, and cosmetic defects with an accompanying sampling plan.

The client had chosen a PVC bottle for the suspension despite us was pointing out that there were issues using PVC instead of the HDP bottle which we had used without problems. But the client was unmoved, PVC was their chosen bottle & included it in the specification.

Therefore, we were somewhat surprised after initial marketing, to receive complaints from the client. Samples returned from the market involved a yellow colour in the product, and particles.

So we travelled to territory to discuss & resolve these issues.
First the yellow colouration would be easy, we thought, since this was interaction between the PVC and product. (AND we had forewarned the client of this!).

However, to our surprise the client insisted that was this was still a problem, our problem despite these previous discussions and warnings.

In reply we politely pointed out the incompatibility between PVC & formulation had been discussed prior to the specification being agreed and at that time we had recommended HDPE bottles since this avoided colouration. Nevertheless, the clients’ representatives had insisted that PVC bottles were not problematic, and the resulting specification was therefore based their requirement for PVC.

Naturally we now urged the client to replace the PVC bottles with HDPE ones.
“Unacceptable” replied the client. It must be PVC bottles and no yellow colour.
Clearly our logic was not getting through.

Next the discussion turned to particles in the product. The client’s sampling programme was explained to us. However, (by now unsurprisingly), this was not the agreed sampling plan.

The client’s method was to filter the liquid and check for any visible particles on the filter. These particles had been identified as “rust”. The testing was performed in an ex-warehouse next to a train line. Whenever train went past, the building shook and rust particles fell from the corrugated roof into the filter holders.

This is the problem, we pointed out, just change the testing room & you’ll avoid the rust.

The client replied that the particles had been identified a “European rust” and not rust from local steel! (It seemed “Face” was involved).

I will leave you to imagine the protracted discussions in achieving a mutually acceptable solution to these issues.

Clearly, adherence to specifications counts for nothing if the client has his own interpretations. More detail and a wider understanding is needed when defining the specifications and the interpretation of results, together with careful contract wording.

It made for a disheartening episode.

Afterwards when walking around the town while waiting for my return flight, I was stopped in the street by two young men in suites, white shirts and ties. They asked me to join them in large hall that was set out for a formal meal. It was a wedding reception & the guy who spoke English explained that it was good luck for the married couple to have a stranger present for the reception and even more luck if he was a foreigner.

It was the only luck I encountered during that particular week!

FOR THE HANTAVIRUS IT WAS A PUBLIC RELATIONS DISASTER

By Tony Dunford

A sideways look at advice to aspiring viruses.

“You had a good thing going in the remote backwaters, but then you tried your hand at something much riskier”.

“The world had forgotten about the Korean War outbreak of hemorrhagic fever with renal syndrome (HFRS) which had mortality up to 12%, and the 1993 USA outbreak of hantavirus cardiopulmonary syndrome (HCPS), - mortality up to 60%. After the Korean outbreak the (first) etiological culprit - (ie one of our family!) -was identified & characterised, & we got named the Hantaan virus (HTNV), and they identified our reservoir in the striped field mouse.

Since then, surveillance has identified multiple strains of our virus family spread worldwide, and our reservoirs in a variety of rodents. But we were given various local human disease names, Our outbreaks in more remote regions caused many different symptoms, often milder than the “Andes strain” which you unwisely decided to spread amongst the 147 passengers & crew on the cruise ship MV Hondius after it left Patagonia.

Deciding to have a go at cruise ship passengers, that's when the world started noticing. It’s one thing to infect locals in remote areas scarcely populated by journalists, & cause various confusing symptoms under the local names, but quite another to target wealthy multinational holiday makers corralled in luxury surroundings.

This means lots of national media outfits are going to pick up on the story and feedback worrying reports to their home countries backed up by dramatic pictures of helicopter rescues and white coated responders. Back home potential victims’ families can be interviewed whilst they worry themselves sick about their loved ones being infected.

Cue “and why isn’t the Government doing something about it”. It’s ideal for a schadenfreude reaction too.
There’re just masses of unwelcome coverage for an ambitious variant.
So, Andes strain the first lesson is “keep your head down”.

Secondly, it's easy to quarantine a cruise liner, which crimps the progress of any gene spreader. Lesson: chose hard to control areas of habitation.

The third mistake you made is being too lethal. Whereas humans at large will not worry too much when the mortality, far away, is 1 or 2%, since they figure out that their chances of catching the disease is pretty minimal. But when the mortality rate is 30% or more of their kin, they really take precautions, yell for vaccines, and the health services mobilise.

Your final mistake is to give human scientists a really valuable, for them not us, case study. They know who was on the boat, for how long, and a lot about passenger’s movements whilst there & before boarding. Already they are into the numbers: 11 cases of infection including 3 deaths amongst the 147, (as at 20th May). These “disease detectives” have been working out transmutability, transmittability, what sort of human-to-human interactions there were & might have been, as well as the original “contamination” (aren’t they rude) from rodent urine or droppings.

So, learn from us older strains that have successfully prospered for millennia.

VARIOUS EPIDEMICS

They come in many forms

By Tony Dunford

The changing media headlines from Hantavirus, to now, at the time of writing, another Ebola outbreak reminds us that there are, sadly, a large variety of epidemics.

And they’re not always ones with severe symptoms; there are others which are mild but very irritating. One of these is the gradual spread of speed bumps or “sleeping policemen” often encountered in the UK, (and in France as I noticed when driving through recently, where they’re nicknamed “gendarmes”). You may be alerted to them by innocent sounding jargon such as “Modified Road Layout”.

Similarly irritating are the “Chat Bots” inserted on websites or in calls one makes; ostensibly to help you answer a query, or reach a human, but in reality, using customers valuable time to teach pet AI systems how to work properly or harvest data.

A third type of epidemic which has spread is waves of meaningless jargon - the sort used to sell IT systems, and consultancy services over the years. Remember “…. so you’ll have a paper free office”.

Current efforts to sell software or support to management now involve lots of spiffy futuristic “filler text”, in reality new forms of meaningless babble to evoke new (vague) concepts.

Here’s a compilation:

“We're thrilled to unveil the Deep Dive Approach:

• If you’ve got the hunger to win then pivot towards the Deep Dive Approach (“DDA”) which will ensure you can sprint towards your lycra stretch goals.
• In doing so your business will achieve a sustainable competitive advantage.
• Given that data is the new oil, DDA will mine all your company data, and so harness the multipler effect.
• To help your Commercial Team reimagine customer centricity, DDAs’ embedded Sales Funnel will open up a cascade of opportunities to provide the full value proposition to delighted customers.
• DDA will have a deep impact on your Production Function, and their resulting relentless execution of cGMP compliance goals and productivity will achieve top right hand quadrant total performance over multiyear horizons.
• When Inflexion points are encountered DDA will provide the opportunity to circle back with agility and reinvent futuristic & holistic solutions.
• With your audacious ambition to have an industry-leading Quality Assurance Department, DDA will ensure your QA team are imbued with a resilient mindset, and are optimally positioned for actionable traction despite the shifting regulatory landscape.”

Glazing over? Well JUST FORGET THE BABBLE, we don’t go in for that Sales & Marketing
If you think Galenisys can help you, come & have a chat over lunch, or give us a call, (we haven’t inserted a Chat Bot).

Folks who've called us recently

Some of the new projects we're working on this Midsummer

1. A European Contract Manufacturing Organisation whom we’re now helping with advice on the potential cross contamination of HVAC systems, and air flows, & risk assessment based on the nature of products involved.

2. At a second company, we’re into aiding their response to audit findings

3. A third project is training Customers staff before a Regulatory Audit and Inspection at a French manufacturer. (Something some of our guys have been doing in various locations worldwide for over 40 years).

4. We’re involved in a project for a major pharmaceutical facility in the Middle East handling biopharmaceuticals and innovative biologics.