Developing novel life science products presents numerous challenges for biotechnology companies, including technical expertise, reagent optimization, manufacturing scale, and logistical support. These complexities are notably amplified in regulated markets. In a recent discussion, Dr. John Pezza, Customized Solutions Director at New England Biolabs® (NEB®), and Mike Pelletier, NEB’s Director of Global Operations, outlined how NEB’s Customized Solutions Team supports partners in overcoming these challenges.
Expectations from Customized Solutions Vendors
According to Dr. Pezza, customers seeking customized solutions should prioritize flexibility, operational integration, and quality assurance. A responsive vendor should have the technical capacity to adapt solutions to diverse needs, from minor formulation adjustments to comprehensive product development. NEB emphasizes support throughout the entire process, from early development phases to large-scale commercial production.
“Customers should also expect a seamless integration of operational systems across manufacturing, testing, packaging, and logistics,” Dr. Pezza stated. The infrastructure at NEB is built on decades of scientific innovation, ensuring clients receive the same rigorous standards applied to NEB’s own products. Furthermore, quality assurance is critical. NEB assures clients that they will receive a comprehensive, audit-ready package that meets both internal standards and external regulatory requirements.
Minimizing Lead Times in Product Development
Reducing lead times is a vital concern for many biotech companies. Dr. Pezza noted that effective communication and process integration are key factors. NEB prioritizes open dialogue with clients, providing direct access to scientific staff to align custom product development with customer expectations.
The company’s vertically integrated model streamlines timelines by minimizing handoffs and maintaining control over critical process steps. This approach is particularly beneficial for customers scaling up from research and development or preparing for commercial launches. NEB’s flexibility helps ensure efficiency while minimizing delays.
Meeting both current and future needs is a priority for NEB, as explained by Mike Pelletier. He emphasized that a forward-looking strategy allows NEB to anticipate customer requirements. “As a privately held company, we can invest in infrastructure, technology, and talent without the pressure of short-term returns,” he stated.
NEB built a 40,000-square-foot Good Manufacturing Practice (GMP)-grade production facility before the pandemic, which significantly enhanced its ability to supply critical reagents for vaccines and other therapies. In 2023, NEB expanded its infrastructure further by adding 100,000 square feet of production space, increasing its capacity to support a wider range of applications and volumes. A new 30,000-square-foot lyophilization facility has also been established to meet rising demands for room temperature-stable molecular biology products.
Vetting Custom Solutions Vendors
For companies considering a partnership with NEB, Pelletier recommends visiting their facilities. These visits allow prospective clients to gain insights into NEB’s operations and meet the team behind their products. He believes that face-to-face interactions often lead to innovative ideas and collaborative opportunities that may not arise through remote communication.
NEB encourages potential clients to schedule audits in advance, ensuring a thorough experience supported by a dedicated audit team. The company’s facilities are designed to meet the highest standards of quality, and audits serve to build trust and reinforce long-term partnerships.
Unique Offerings of NEB’s Customized Solutions Team
One aspect that may surprise potential customers is the comprehensive nature of NEB’s customized solutions. Dr. Pezza highlighted that NEB provides a true end-to-end experience, encompassing collaborative development, custom formulation, and a range of fill sizes and container types, including customer-branded packaging.
The company’s capabilities are supported by a dedicated lyophilization facility and in-house oligonucleotide production, which enhances responsiveness and control over the supply chain. “We have supported pandemic-level demand without interruption, including for key partners such as Moderna,” Dr. Pezza explained.
NEB’s operations benefit from the institutional knowledge of its employees, with low turnover rates ensuring continuity and accumulated expertise. The same scientific staff involved in product development also participates in customization efforts, fostering trust and facilitating quicker problem-solving.
Through ongoing investments in infrastructure and sustainable practices, NEB demonstrates its commitment to meeting both current and future customer demands. This forward-thinking approach ensures that clients have access to the necessary capabilities, capacity, and innovation to navigate the ever-evolving landscape of biotechnology.
