How NEB’s Customized Solutions Team Drives Innovation and Partnership in Biotech

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When developing novel life science products, developers may face challenges in areas such as technical expertise, reagent optimization, manufacturing scale, turnaround time, reagent quality, and comprehensive logistical support. These complexities are particularly magnified within regulated markets. In this Q&A, John Pezza, PhD, Customized Solutions Director at New England Biolabs^® (NEB^®), and Mike Pelletier, NEB’s Director of Global Operations, discuss the resources and support that companies should expect from a reagents partner to navigate these challenges that come with developing custom products.

Q: What should customers expect from a customized solutions vendor (provider)?

John: Customers should look for a combination of flexibility, operational integration, quality assurance, and evidence of long-term commitment from their custom solutions vendor. Flexibility requires a technical capability to tailor solutions to a wide variety of needs, ranging from minor formulation adjustments to complex, end-to-end product development. A flexible vendor will also be able to support customers at every stage, from early development and pilot batches to full-scale commercial production, with the agility to scale volume and adapt to evolving requirements.

Additionally, customers should expect the integration of robust, well-coordinated operational systems across manufacturing, testing, packaging, and logistics. Our customized solutions infrastructure was built upon our own internal standards, standards shaped by decades of scientific innovation. This means our customers benefit from the same rigor and reliability we apply to our own product development.

Finally, customers need quality assurance. They should expect a comprehensive, audit-ready package that meets internal quality standards and external regulatory expectations, as well as support from a quality team with extensive experience in regulated markets.

These three pillars are strengthened by our commitment to long-term partnerships and to sustainability, both of which inform how we design, produce, and deliver our products.

Q: How can vendors minimize the lead time for custom product development?

John: Lead time is shaped by several key factors, including communication, process integration, and the ability to scale efficiently. At NEB, we emphasize open, frequent, and transparent dialogue— supported by direct access to our scientific staff—to ensure that the development of custom products remains on track and aligned with customer expectations.

Additionally, our vertically integrated model allows us to streamline timelines by reducing handoffs and maintaining control over key steps in the process. Finally, whether a customer is scaling up from R&D or preparing for commercial launch, our flexible infrastructure and collaborative approach help minimize delays and maximize efficiency.

Q: How do vendors ensure they are able to meet current and future needs?

Mike: Meeting current and future needs requires foresight, agility, and a commitment to continuous improvement. As a privately held company, NEB has the flexibility to invest in infrastructure, technology, and people without being constrained by short-term returns.

Unlike vendors who invest reactively, we have the freedom to take a forward-looking approach: anticipating customer needs and investing ahead of demand. For instance, we built a 40,000-square-foot Good Manufacturing Practice-grade (GMP-grade*) production facility before the pandemic, enabling us to supply critical reagents for vaccine and other therapeutic modalities at scale. In 2023, we expanded our production infrastructure further with the addition of 100,000-square-feet of space, significantly increasing our capacity to support customers across a broader range of applications and volumes. We also opened a 30,000-square-foot lyophilization facility to meet the growing demand for room temperature-stable molecular biology products.

These investments are part of a broader strategy that includes ongoing support for basic research, new product development, and infrastructure expansion, all designed to ensure that we can meet current and future customer needs. In parallel, we continue to invest in sustainable practices across our operations, from energy-efficient facility design to waste reduction initiatives. By staying ahead of the curve, NEB ensures that our customers have access to the capabilities, capacity and innovation they need—not just today, but well into the future.

Q: How can customers vet their custom solutions vendor?

Mike: NEB encourages prospective customers to visit our facilities in person. These visits offer a firsthand look at our operations and provide an opportunity to meet the people behind the products. Our team’s enthusiasm, expertise, and commitment to customer satisfaction are best experienced face-to-face. Often, facility visits spark new ideas and uncover opportunities that might not emerge through emails or phone conversations alone.

We also encourage customers to schedule audits in advance to ensure the best possible experience, supported by a dedicated audit team. Our facilities and documentation are designed to meet the highest quality standards, and we view audits as an opportunity to build trust, demonstrate transparency, and strengthen long-term partnerships.

Q: What might surprise people about NEB’s customized solutions offering team?

John: Many are surprised by the depth and integration of NEB’s customized solutions and capabilities. We offer a truly end-to-end experience: from collaborative development and custom formulation to a wide range of fill sizes, container types (including plate filling), and customer-branded packaging. Our dedicated lyophilization facility and in-house oligonucleotide production allow us to support customers with unique supply chain needs, offering a level of control and responsiveness that’s rare in the industry. Crucially, these capabilities are not siloed—they’re part of a unified, vertically integrated platform designed to deliver scientific and operational value.

The scalability of our operations often exceeds expectations. We have supported pandemic-level demand without interruption—including for key partners such as Moderna—while our documentation has been refined through decades of audits to meet the highest standards across diverse applications. Moreover, our quality team has significant experience in regulated markets, ensuring that customer compliance requirements are properly understood and consistently met.

The depth and scale of our capabilities is enabled by the institutional knowledge of our employees. Our exceptionally low employee turnover ensures continuity and accumulated expertise, and our scientific staff remains engaged throughout the collaboration. Many of the same scientific staff who develop our products are also involved in customization efforts, providing continuity and deep technical insight. This long-term engagement fosters trust, accelerates problem-solving, and ensures that customers receive consistent, high-quality support across the lifecycle of their products.

* “GMP Grade” and “GMP-grade” are branding terms NEB uses to describe products manufactured or finished at NEB’s Rowley facility. The Rowley facility was designed to manufacture products under more rigorous infrastructure and process controls to achieve more stringent product specifications and customer requirements. Products 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.

For more information or to inquire about an opportunity to collaborate, contact us at www.neb.com/customizedsolutions.