Ep. 44: Vaccine Vials and COVID Innovations

Show Notes

Lawrence Ganti, president of SiO2 Materials Science, joins me to discuss ramping up production of his innovative vaccine vials to distribute COVID-19 vaccines. We also discuss how the pandemic in general affected scientific innovation and medical product manufacturing, and what it could mean for the future of medicine.

What is Sounds of Science?

Sounds of Science is a monthly podcast about beginnings: how a molecule becomes a drug, how a rodent elucidates a disease pathway, how a horseshoe crab morphs into an infection fighter. The podcast is produced by Eureka, the scientific blog of Charles River, a contract research organization for drug discovery and development. Tune in and begin the journey.

- [Mary] I'm Mary Parker,
and welcome to this episode

of "Eureka Sounds of Science."

(serene music)

Nothing can make up for the
devastating losses caused

by the COVID-19 pandemic.

Every aspect of our lives
seems to have been impacted.

However, there is a small silver lining,

the incredible advances in
medical treatment and technology

that has come from the
cooperation of researchers

and the resources they were
granted to fight the virus.

Joining me today is Lawrence Ganti,

the president of SiO2 Materials Science,

a company based out of Alabama.

One of the company's
products is vaccine vials,

which obviously grew in
demand during the pandemic.

He's here to discuss how
COVID impacted his company

and the greater trend of
COVID's overall effect

on emerging medical technologies.

Welcome, Lawrence.

- [Lawrence] Welcome, I'm happy to here.

Thank you very much.

- [Mary] We're very happy to have you.

So, can we start with a little bit

about your company's history?

When were you founded?

- [Lawrence] Sure. SiO2 Materials Science,

we were founded in late 2012,

and we were kind of a spin
out of another company

called CSP Technologies,

which was making plastic tubing

for the medical device industry.

And we spent, really the last I would say,

eight, nine years doing
research and development

of coming up with this new material,

which is what ended up

forming these new COVID vaccine vials.

- [Mary] And can you
describe the vaccine vials?

What are their strengths?

- [Lawrence] So the vials themselves,

normally vaccine vials or medication vials

are typically using traditional glass,

so they're a small glass vial.

What we've done is we've
invited a new material,

which is a hybrid of glass and plastic.

So typical problems with glass

is if you drop it, it breaks, right?

Everybody knows that glass
has those kind of problems.

There are other problems,
in terms of delamination,

where you have metal
particles and glass particles

that come off the vials
into the medication.

Those are kind of well
known in the industry,

but there hasn't really
been an alternative.

So over the last 10 years,

what we've done as a company

was try to eliminate all
these kind of problems

and invent, effectively, a new material,

which is a hybrid, it
fuses glass and plastic.

So the out shell, the
vial itself is plastic.

It's a polymer, it's unbreakable.

You can run it over with a Hummer,

you can drop it out of a building.

It doesn't break.

But, the inside of the vial
has a microscopic lining

of glass, and it's pure SiO2,
hence the name of the company,

where it's 30 times
thinner than a human hair,

so you don't actually
see the glass lining,

but it has all the protective
barrier properties of glass.

Glass, as we may or may not know,

is often used in packaging

when you need to keep out
moisture and keep out oxygen.

And most of these biological
drugs and vaccines

need to have stability against moisture

and against oxygen coming
into the container.

That's why you don't see
typical plastic vials

being used for medication.

- [Mary] Right.

That makes sense.

How does the process work?

How do you get this thin layer
of glass on top of plastic?

- [Lawrence] So it's a process

that's called plasma enhanced
chemical vapor deposition.

It's a technology that was
invented many years ago

and used in the microelectronic space.

So you're typically seeing this kind

of plasma deposition used in microchips,

places like Intel,
Cisco, places like that.

But, they've never been
successfully applied

in a medical setting.

And the main challenge with medicine

is that you can't have a 99.9% barrier.

You have to have 100% barrier.

Whereas microelectronics,

things that are not being
injected into your body,

it's close enough, right?

But for us, being able to
come up with this technology

was really what we
spent the last 10 years,

was how do you create this
microscopic layer of pure glass

without it affecting the
integrity of the plastic vial,

but at the same time,

ensuring and guaranteeing
that you have 100% coverage,

and that's what we've bee
needing over the past years.

- [Mary] Yeah, Charles
River has a department

that does endotoxin testing
and all those sort of things.

And this is obviously the sort of thing

that would totally need an endotoxin test

'cause it goes into the bloodstream.

So the glass is thick enough
to prevent any microbes

from entering into the specimen itself?

- [Lawrence] Absolutely, so we've worked

with Charles River Labs,

we've worked with a number
of other testing labs.

So the typical things that they test for

is they test for whether
microscopic entities

can go in and out of the container.

But also, what they also test
for is that plastic and glass

have things called
extractibles and leechables.

These are things that come off
the actual container itself.

It's inherent to the material.

And what they're testing
for is how much of that

is coming into the substance,

or coming into the liquid of the vial.

And we're crystal clean.

I mean, we're better than plastic,

and we don't have any of
the problems of glass.

So that's why we like to say

that we have the best of both worlds.

We have all the protective qualities

that are needed from glass,

in terms of oxygen and moisture barrier,

but we don't have the typical
endotoxin profile of plastic.

We're a much cleaner substance.

So we're equivalent to glass,

and we're equivalent to plastic,

and we've eliminated all
the drawbacks of both.

- [Mary] Yeah.

This is completely on a separate topic,

but now I'm imagining a car windshield

with this very thin layer
of glass over plastic,

making it maybe not so prone to cracking

if it gets hit by a pebble on the highway.

That'd be pretty cool.

- [Lawrence] So we actually are working

with various government entities
on various applications.

On the one hand, you're
taking this application,

and we've used it for biological syringes.

We've used it for vaccine vials.

There's even a leading
baby bottle manufacturer

that got one of the Top
10 Products of the Year

by Time Magazine.

They're using our technology,

so it's basically a plastic bottle,

but the inside, the baby's
milk is only touching glass.

The applications are endless.

I mean, you could use it on
bulletproofing of certain cars.

You can use it on mascara tubes.

You can use it on baby bottles.

So there's endless
possibilities to the technology.

- [Mary] Very cool.

And just out of pure curiosity,

can any of these be made
from recycled materials?

I assume they can't be recycled afterwards

'cause of the bonding.

- [Lawrence] That's correct.

Well, the thing is, they can be recycled

depending on the use.

A baby bottle can be recycled

because arguably you're only using milk.

If you're using a drug,

drug containers are not
able to be recycled.

They're treated as medical waste.

So it doesn't matter if
it's plastic or glass.

Once there's medicine put
inside of the container,

they're treated as medical waste.

Now, having said that,

if you're thinking from
an ESG perspective,

we use 10 times less
heat energy than glass.

We use almost no water.

Where our footprint is much smaller

than a glass manufacturing site.

So we're much more
environmentally friendly

than, say, traditional glass
manufacturing of vials.

- [Mary] Oh, that's good.

So, I mean, obviously, since
your company broke off in 2012,

you've had these vials since before COVID.

But how did COVID affect demand for them?

- [Lawrence] For us, the demand
went up quite dramatically,

in the sense that we were
starting off, initially,

as a syringe manufacturer.

Most of our customers
were looking for syringes,

using the same technology.

Now, what happened during COVID

was there was a massive uptick

in terms of the need for
vials and that came across.

You had anywhere between 10 and 15

potential drug manufacturers
who were working on vaccines.

All of them needed vials.

So what happened was is
there was a glass shortage,

and in our discussions
with the US Government,

as they started to look at
rebuilding the infrastructure

as part of Operation Warp Speed,

in our discussions with us,

we were able to explain to them

how we can ramp up our
manufacturing quite fast.

Typical glass manufacturing,

if you're gonna build a
new manufacturing site,

it takes anywhere between 24 and 36 months

to build a new factory.

But for us, building a new factory

was taking six to nine months,
so substantially shorter.

And that's just because
the technology's different.

It's a much faster scaling technology.

We also use a very different supply chain.

We're not using glass or glass
sands at all in our process.

So we're basically using plastic resin,

and then various gases to
produce the glass-like barrier.

So for us, our capacity,

our ability to produce the vials

went from producing 10
million vials per year

to, all of a sudden, producing
10 million vials per month.

And that was a huge benefit
to the US Government

and to some of our customers,

to be able to supply them vials
very quickly for COVID-19.

- [Mary] So how fast were you
able to ramp up production

to that level?

- [Lawrence] Oh, that was crazy.

If I remember that time,

I mean, literally we built four factories

in less than nine months.

These are kind of green fielded factories,

so we ramped up very quickly.

We went from 10 million vials
producing on an annual basis

to producing that much on a monthly basis.

We were not meeting the demand
that we were required to,

so we continue to scale since that time.

- [Mary] Yeah, and it seems
like demand for the vaccines,

and for boosters, and
for subsequent variations

is probably gonna be continuing,

although hopefully if
we're lucky as a species,

not to quite the same
extent that we've had

to get to where we are now.

- [Lawrence] Correct.

And the thing is, what happened with this

is that there was so
much uncertainty, right?

Even to the point where people were saying

we didn't know how many
doses they were going

to fit in a vial.

So initially we were thinking,

"Okay, we're producing
10 million per month.

That's 120 million vials per year."

But people forget that

that translates into 1.2
billion doses, right?

Because you're talking about
10, and now it's actually 15,

10 to 15 doses per vial.

These are multi-dose vials,

and along with that,

being able to put
together shipping studies.

It's not just producing the vial.

You're producing a
substantial amount of data,

a substantial amount of
documentation, evidence to submit.

Our customers, when they submit
their regulatory approval,

they're submitting the
approval of their drug

or vaccine inside of our vial,
or inside of our container.

- [Mary] Yeah, I think that's something

for people to keep in mind.

When people talk about thinking

that the vaccines were
produced so quickly,

it's not so much that
the science wasn't there.

It's like that's really
what got them through.

The science was there.

We'd already studies mRNA vaccines.

We'd already studied other Corona viruses.

And, companies like yours
had these systems in place

to scale up production quickly

that really saved the day

in terms of putting this stuff out there

as quickly as possible.

- [Lawrence] Well, yeah.

And to your point, we were working

with these mRNA vaccine
companies way before COVID.

So they had done what we
call stability testing

of the type of drug, or type of vaccine,

inside of our containers for
months, many months beforehand.

In some cases, sometimes
multiple years of data.

So it's not like, all of a sudden,

here comes this new vaccine
vial and a new vaccine,

and you put it together.

The work has been done, as you said,

for many months before COVID even hit.

- [Mary] Yeah, exactly.

I really try to emphasize that
with people when they ask me

if working in the drug industry,

how did we get these vaccines so quickly.

It's like, well, the bedrock was there,

and we had an incredible
motivating factor,

and also funds from the government

to offset risk for companies
putting a lot of energy

into something that they weren't sure

if it was gonna work or not.

- [Lawrence] Correct.

- [Mary] Yeah.

So how much lead time did you get?

- [Lawrence] Like three months.

(both laugh)

- [Mary] Sounds about right, yeah.

- [Lawrence] Three months
to go from zero to 100,

and as soon as possible.

It was kind of just go, run.

Run as fast as you can, and
put everything together.

We ended up doing...

And it's very interesting.

People think that people did shortcuts.

It's actually the other way around.

Because you can't really
do shortcuts in pharma,

you need the data and documentation.

What we ended up doing,

we actually ended up
spending a lot more money

on overdoing things,

or having studies done multiple times

because you couldn't afford to say,

"Okay, if this sample wasn't
working, submit another one,"

and wait another three months, right?

Really it was, "Okay, you have samples,

send them all, get them all
tested, and then come back."

And then we'd say okay, well,
then you ended up scrapping

or throwing out a bunch of stuff.

Which okay, at the time speed
was more important than costs.

- [Mary] Yeah, yeah.

And things were being done concurrently.

It's like they might be
manufacturing the vaccine itself,

and you're manufacturing the vials,

and you guys were hoping
that your timelines

will meet up, but you don't know for sure.

- [Lawrence] Right, right.

- [Mary] So speaking of which,

bringing in the bigger
picture, what are your views

on how COVID has shaped
innovation, generally?

- [Lawrence] I thought that there

was a lot more emphasis on collaboration.

If you had asked me six
months ago, I would have said,

"Yeah, definitely this
has driven collaboration."

I actually don't know if it has, right?

I kind of see pharma almost reverting back

to being isolated individuals again.

What I do think has happened is that...

You mentioned mRNA vaccines
being around for some time,

or the technology being
around for some time.

The general nature of
pharma is it doesn't pay.

I hate to say this, but it doesn't pay

to focus on certain tropical
diseases or certain vaccines,

which might only affect a
small population, right?

So what happened was nobody was focusing

on some of these COVID
type of vaccines because...

All right, it's a vaccine.

Where everybody was
focusing on was cancer.

Everybody focuses on cancer.

All the cell and gene therapy
is focusing on rare diseases.

There's more money there.

But then, the patient
population is smaller.

The money required to
do large scale studies

is not as much if you were doing it

for a more general population.

So what happened was is that mRNAs

were maybe not so successful
in some of these cancers

or rare diseases,

and there was a lot of
work and trials being done.

But then, when it came to
something more mainstream,

something that didn't require

what I would call durability of the drug,

that it just attacks and then goes away

versus having to stay
in your system for...

A cancer, it's a longer term therapy

that has to be there for extended periods

of time to kill the cancer.

I think what happened was
is that people started

to realize that okay, with a
substantial amount of money,

there was a lot of things
that can be battled in pharma.

But private industry is
not always gonna be focused

on the same thing as, say, government.

And if you bring the two together,

really the opportunities are endless.

The way we brought multiple
vaccines for COVID-19 to market

was really because there
was a huge emphasis,

and there was a financial element.

Look at BioNTech, Moderna,
these companies were startups,

and they had substantial investments,

but they didn't have an endless pocketbook

to be able to produce things.

Now, these are multi-billion
dollar companies

based on a single drug or vaccine.

It changes the way we have to
think about drug development

and how companies are formed

and how they're motivated
to bring things to market.

So imagine taking that same kind of money,

putting that towards HIV.

It's not unrealistic to think

that we could wipe out the HIV virus

with the right amount
of substantial funding,

and focus and energy around that.

- [Mary] Mm-hmm.

Oh, wouldn't that be something?

But luckily, I mean, none of
these things exist in a bubble.

Any advances that get made in one area

could potentially be applied
to advances in another area.

- [Lawrence] Yes.

- [Mary] Fingers crossed.
- [Lawrence] Fingers crossed.

- [Mary] So beyond your own products,

what if any changes do you see

to pharma packaging, post COVID?

- [Lawrence] Well, pharma
is still an industry

that is adverse to change.

It's embedded in the way the
industry operates, right?

There's so much risk taken
into developing a new drug

that the rest of the
pharmaceutical supply chain

is all about eliminating risk.

So if you come out with this brand new...

Take us, for example.

You come out with this brand new,

arguably 100 times better
package, but it's still new.

The pharma companies are very risk averse.

Now, we benefited because pharma companies

were almost forced to try our technology

because they couldn't get
access to the old stuff.

Right? That's helped substantially.

But going forward, what
I would like to see

is I'd like to see more elements

of the pharmaceutical supply chain

looking at newer and
cutting age technologies

of how they can solve problems.

And I don't know if I see
that moving very quickly.

There's a lot of incumbents
along the supply chain

that are highly resistant
to any kind of change.

- [Mary] Right.

I think we will have
to eventually, though,

if we want to survive as a species

because we're going to have
to start majorly factoring

in things like climate impact.

Factoring that into a supply
chain from any industry

is, I think, gonna be a much
bigger deal going forward,

or at least it should be.

- [Lawrence] Sure. No,
I agree with you, 100%.

Everything relates to incentive, right?

And I'm a big believer in that.

People do, and organizations do,

and entities do what
they're incentivized to do.

So until the incentives are aligned,

we can talk about environmental,

ESG and sustainability all we want,

but you're gonna get some people

who are moving in that direction,

but you're not gonna get large amounts

of industry moving there,

unless there are substantial
incentives to do so.

And those don't have to be
monetary incentives, right?

It could be workforce incentives, right?

You're not gonna be able to
hire the top talent anymore

because the top talent
of the next generation

are all worried about sustainability.

So if you're not moving in that direction,

then you're not gonna
hire the right people.

I mean, that's also incentive.

When I talk incentives,

I'm not talking about
just dollars and cents.

- [Mary] Yeah, that's a good point.

I hadn't thought about that,

but I think that's definitely the case.

All right, well, thank
you so much, Lawrence,

for providing your insights.

Good luck with the scaling, going forward.

- [Lawrence] My pleasure.

- [Mary] I think it'll be a
long term thing, for sure.

- [Lawrence] Absolutely, and
we're just trying to help out.

We're trying to save the
world one vial at a time.

And we have a fantastic team,

a great group of people who
are working day and night

with their families to really
try to make things work.

So, thank you for the time.

It was a great conversation.

- [Mary] Thank you so much.

- [Lawrence] Cheers, take care.

(upbeat music)