OEM & Customized Solutions Case Study: Quality & Specifications

Learn how NEB helped a startup company manufacturing a novel therapeutic with GMP-grade* enzyme.

Script

Deana Martin: Today we're speaking with John Pelletier from NEB's Customized Solutions team. Hi, John.

John Pelletier: Hello.

Deana Martin: Thanks for joining me.

John Pelletier: You're welcome.

Deana Martin: So could you start by telling me a little bit about your job role within the Customized Solutions group?

John Pelletier: 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.

John Pelletier: I also work 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.

Deana Martin: Right, right. So NEB has two facilities, correct?

John Pelletier: That's right.

Deana Martin: Could you tell us a little bit about those?

John Pelletier: 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 the facility here in Rowley, Massachusetts, which is engineered and operates to produce GMP-grade products.

Deana Martin: And what does GMP-grade materials mean?

John Pelletier: So GMP-grade materials are tools that our customers require in the manufacture of their products.

Deana Martin: Okay. So we're not producing GMP products. We're producing reagents that they'll use in their processes?

John Pelletier: Precisely.

Deana Martin: Correct.

John Pelletier: 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.

Deana Martin: Okay.

John Pelletier: 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 for their cGMP manufacturing.

Deana Martin: Can you share a little bit of the specifics behind the manufacturing process at the GMP-grade facility?

John Pelletier: 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.

Deana Martin: So I want to shift gears a little bit and talk about NEB's commitment to quality. In your own words, can you tell us what that means?

John Pelletier: Sure. NEBs 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.

John Pelletier: Further to that, our QA and QC systems, which support all of those efforts and underpin 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.

Deana Martin: And how has this commitment helped our customers? Do you have a story that comes to mind?

John Pelletier: Sure. A really good one 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&D teams, together we discovered that there's another product in our wares that would work much better for them.

John Pelletier: So we quickly engaged the R&D team, process development, production and quality, to give a hard review of the feasibility of moving that other product into production and ultimately onto GMP production, to enable the customer to use it in a relatively strict timeframe.

Deana Martin: So what benefit did the GMP-grade manufacturing offer the customer?

John Pelletier: Actually, a good number of benefits. First, 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.

John Pelletier: 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.

Deana Martin: Okay.

John Pelletier: So it reduced the other reagents that come into the process and ultimately reducing the risk score of the introduction of this product.

Deana Martin: 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?

John Pelletier: I guess I would recommend that they look at our website and review the page for customized solutions. There you'll see the address for a [email protected], where they'll engage a team that'll really help advise them on what is the best quality product and under which production environment would best serve them.

Deana Martin: Great. Great. Well, thank you so much for joining me today.

John Pelletier: You're welcome.


 

"GMP-grade" is a branding term NEB uses to describe reagents manufactured at NEB’s Rowley facility. The Rowley facility was designed to manufacture reagents under more rigorous infrastructure and process controls to achieve more stringent product specifications and customer requirements. Reagents manufactured at NEB’s Rowley facility are manufactured in compliance with ISO 9001 and ISO 13485 quality management system standards. However, at this time, NEB does not manufacture or sell products known as Active Pharmaceutical Ingredients (APIs), nor does NEB manufacture its products in compliance with all of the Current Good Manufacturing Practice regulations. 

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