Today we're speaking with John Pelletier from NEB's
Customized Solutions team. Hi, John. Hello.
Thanks for joining me.
So could you start by telling you a little bit about your job
role within the Customized Solutions group?
Sure. I'm fortunate to work with
our customers that are in the regulated
markets, as we call it,
customers that have a requirement for
GMP grade products
and they're primarily working in the areas of
mRNA therapeutics, DNA therapeutics,
and genome editing.
They have a defined need for GMP grade tools
that go into the manufacture of their
products.
I also worked closely with inside teams
in NEB, that includes the NEB Solutions Team
and the NEB Steering Committee,
whose functions are to serve those
customer requirements, and we leverage those
resources as we engage with those customers
to secure their supply chain
and their product requirements.
So NEB has two facilities, correct?
That's right. Could you tell us a little bit about those?
In Ipswich, we have a 140,000
square foot facility
that houses research and production.
That facility is certified to
ISO 9001 and 13485.
In addition, we have facility here
in Rowley, Massachusetts, which is
engineered and operates to
produce GMP grade products.
And what does GMP grade materials means?
So GMP grade materials are
tools that our customers require in the manufacture
of their products. Okay, so we're not
producing GMP products. We're producing
reagents that they'll use in their processes?
Precisely. Correct. Again, they have
strict requirements for the production
environment,
the kinds of QCs that are applied, the
quality systems and how the product is released
and ultimately even shipped out to them. So
all facets of production are controlled
in a different way, in a much more tight manner,
to meet those stringent requirements the customer has
four their cGMP manufacturing.
Can you share a little bit of the specifics behind
the manufacturing process at the GMP grade
facility?
The new facility is animal-free.
It includes extensive environmental
monitoring systems,
ISO 8 clean room facilities, and
ISO 5 filling suites.
The process starts with characterized
master cell banks,
dedicated chromatography resins are used,
and throughout, in-process and post-processing
controls are applied.
Products are moved through a battery of QCs
that assess for activity,
levels of contamination, as well
as compendial assays including
endotoxin and bioburden.
So I'm gonna shift gears a little bit and talk about NEB's
commitment to quality. In your own words
can you tell us what that means?
Sure, NEB's commitment to quality started
over 45 years ago as we
led the charge in the quality control
of the enzymes we first introduced.
That's been enhanced and
underscored, that commitment has been underscored,
by the application of our certifications
for both ISO 9001
and ISO 13485.
Further to that, our QA and QC
systems, which support all
of those efforts in underpin all
all of the strengths of our quality systems,
are operating behind the scenes.
Our quality control group, further, is
constantly
furthering the development of new QCs.
We're also willing to apply customer
required QCs and compendial assays
as necessary, so a full range
of QCs can be applied.
And how does this commitment help
our customers? Do you have a story that comes to
mind?
Sure. A really good one and
sort of recently is,
there was a startup that engaged NEB
for the supply
of a particular reagent that was critical
to the processing of their pharmaceutical
product,
and they came to NEB thinking that's the
product they needed.
But when they engaged with our R and D teams,
together
we discovered that there's another product
in our wares that would work much better for them.
So we quickly engage the R and D team,
process development, production and quality,
to give a hard review of
the feasibility of moving that other product
into production and ultimately on to
GMP production,
to enable the customer to use it in a relatively
strict timeframe.
So what benefit did the
GMP grade manufacturing offer
the customer?
Actually, a good number of benefits.
First, you know the quality environment
and the production environment, the ability
to provide them with the GMP grade material
was critical.
Further, to their concerns regarding scale,
we can operate at the same scale here and actually
greater going forward
than the current facility in Ipswich. So
quality
and scale,
I could say those are probably the two
primary ones, but also the performance
of the reagent. Again
by introducing another reagent
into their thinking and their mindset, they
were able to work with a reagent that simplified
their workflow.
So it reduced the other
reagents that come into the process and ultimately
reducing the risk score of the introduction
of this product. So if I were a customer
and I wasn't sure whether I needed the over
the counter reagent or
GMP grade material, what would I do?
I guess I would recommend that they
look at our website
and review the page for customized
solutions.
And there you'll see the address for a custom@neb.com,
at any be dot com, where they'll engage
a team that will really help advise them
on what is the best
quality product and under
which production environment would best serve
them. Great, Great.
Well, thank you so much for joining me today.