Biocurious: Stolen kisses as Clever Culture wins a rare Big Pharma public

• Two of Clever Culture’s Big Pharma customers have publicly backed the company’s APAS agar plate reading units
• Plate monitoring plays a crucial role in sterile drug-making facilities
• AstraZeneca’s and CSL’s reps believe automated plate reading is more accurate than the human eye

As a rule, big companies are reluctant to endorse smaller suppliers – at least by way of public displays of affection.

Their reticence is understandable, given overzealous small fry have been known to conflate a mere sniff of interest with a full-blown contract.

In the life sciences sphere, Big Pharma companies deal with hundreds – if not thousands – of minnows in various ways.

Most of the time it equates to speed dating and not even a romp in the hay, let alone a PDA.

Given that, Clever Culture Systems (ASX:CC5) scored a coup by persuading two of its biggest big pharma customers to update investors on how – and why – they use the company’s automated plate-reading tech, APAS Independence.

The nifty device automates the reading and processing of thousands of agar plates daily.

Drug makers and labs use these biologic vessels to monitor impurities in high-level sterile facilities.

The Big Pharma customers in question are Clever Culture’s foundation client AstraZeneca and Australia’s own CSL (ASX:CSL).

They are among eight top-20 global pharma companies that have adopted APAS or are formally evaluating the device.

CSL’s global head of quality control operations Craig Stephens says medtech sales teams can deliver a good pitch, but ultimately the device may not deliver.

“We were very cautious going into this.”

Humans: the weakest link

Stephens says in microbiology there’s a belief that humans don’t make mistakes.

“The reality is, there are errors that are deliberate and errors that are not deliberate”.

The latter includes “not picking up a tiny dot on the edge of the plate”.

More darkly, regulatory auditors have pulled plates out of rubbish bins and found live colonies, whereas the paperwork has registered zero germs.

CSL has not been involved in such “deliberate falsification” which, Stephens says, has damaged the industry’s reputation.

“To combat that, a lot of companies have resorted to a second person doing the same activity: counting a tiny organism at a macroscopic level on an agar plate.

“I’m a strong believer that a well-qualified, well-programmed system can be just as good or better than a human because it’s just code: ones and zeros.”

He adds that the regulators also prefer the machine over the human mind – as well as proper electronic record-keeping.

Roll ’em out

AstraZeneca’s global head of microbiology Karen Capper concurs that “people make mistakes and miss samples”.

She says: “all of those results are manually punched into a computer. You will get errors when you punch in lots of zeroes”.

Capper says plate reading has been a “weak link in our business for many years”.

AstraZeneca is Clever Culture’s foundation poster client, having rolled out 12 instruments to date.

Capper is based at the company site in Macclesfield near Manchester in the UK, which requires two people to read 30,000 plates monthly.

“It’s a highly intensive task and super important for patient safety,” she says.

“It’s also a manual process and involves a lot of fatigue.

“Therefore, the regulators require … one person reading them and a second person doing verification.”

Not surprisingly, the trained operatives performing this mundane task want to do “proper science” instead.

“We have turnover in those labs and that’s a continuous issue,” Capper says.

First Broadie, then the world?

CSL has acquired one APAS unit, for pilot validation at the company’s sterile manufacturing facility at Broadmeadows, in northern Melbourne.

Stephens stresses the company has not made any formal commitment to acquire more APAS units.

But he says APAS dovetails with CSL’s quest to drive operational efficiency improvements, so the company can expand volume with fewer incremental resources.

He sees APAS as most applicable to CSL’s core plasma therapy operations.

CSL collects plasma donations, freezes them and then fractionates the material into injectable products.

“When you’re injecting something into a patient, the absence of microbial contamination is of utmost importance,” Stephens says.

CSL also has key sterile manufacturing facilities in Bern (Switzerland), Marburg (Germany) and Kankakee (south of Chicago).

Overall, these plants produce one million agar plates – all read manually to date.

In line with CSL’s onshore US manufacturing push driven by You Know Who, the company is expanding Kankakee.

“We’re working towards standardisation around instrument selection and making sure it’s fit for purpose,” Stephens says.

“You need to go through that qualification activity to ensure that you get what you are looking for and don’t create new problems.”

Counting the cost

In a sector in which multi-million-dollar acquisitions barely move the needle, spending US$350,000 ($500,000) on an APAS unit won’t bother Big Pharma’s bean counters unduly.

But given the crucial nature of the plate-reading function, such purchases will still be subject to rigorous cost-benefit analyses.

“APAS delivered the biggest benefit while performing quite admirably on cost,” Stephens says.

Capper says AstraZeneca looked at six other automation systems, but they were expensive and required too much lab space.

“At Macclesfield we would have needed 28 instruments, whereas with APAS we needed three, so it was an easy decision.”

She says APAS also needed to benefit all of the company’s major sites, rather than two or three of them.

CSL also had a look-see at other devices, but Stephens said the need to purchase bespoke plates was problematic.

APAS does not tie users to a particular “proprietary consumable”.

Stephens said some of the other offerings provide too much unrequired functionality (at a cost, of course).

“APAS is in a nice sweet spot that addresses the automation I need, but not going beyond that.”

Stephens says an investment payback period of around five years is usually easy to get across the line internally, while three years is very quick.

“For these sites, in most cases it’s less than a year [for APAS].”

Gathering pace

Over the last two years, Clever Culture has honed its strategy to focus on the world’s biggest pharma companies with centralised quality control centres of excellence.

“That’s because they have the most to gain from APAS if they do it in this centralised fashion,” CEO Brent Barnes says.

For the record, Clever Culture’s other Big Pharma customers include Pfizer, Novo Nordisk, Bristol Myers Squibb and Thermo Fisher Pharma Services (Patheon).

Clever Culture also has aligned with a US life sciences services company, PSC Biotech, to penetrate the mid-level market cost-effectively.

PSC sells services to pharma manufacturers.

Under the compact covering the US, Canada and Singapore, Clever Culture pays PSC a commission for lead generation.

Clever Culture remains responsible for negotiating the price and supplying the units.

PSC also runs a contract sterile injectable drug-making arm and has acquired its own APAS unit.

Barnes says the tie-up gives Clever Culture the “arms and legs” to access the pharma mid-tier.

He adds that sales are likely to come incrementally, rather than in a rush.

‘Brilliant piece of kit’

Clever Culture’s evolution has been slower than many investors would have liked, with missteps along the way.

“Timelines take so long because it’s all about patient safety,” Barnes said.

“When things go wrong, they can go wrong in a catastrophic way.”

Drug company execs have nightmares about drug recalls caused by faulty manufacturing.

“Automation is about reducing risk and putting patients first,” Barnes says.

“There are no short cuts.”

As any advertising Mad Man would know, product endorsements are more believable if they come from respected third parties.

We’re not talking about Brand Power or paid influencers with names like Chiara or Aimee.

Without a gun to her head, Capper describes APAS as a “brilliant piece of kit” her company has sought for three decades.

“Once you put it into a lab, nobody’s going to let you take it away”.

Similarly untroubled by a metaphorical small-piece firearm, CSL’s Stephens says: “No solution is perfect. But for what we were looking for, it’s a nice balance.”

At Stockhead, we tell it like it is. While Clever Culture is a Stockhead advertiser, the company did not sponsor this article.

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