Biologics Manufacturing in the Heart of the Boston Biotech Hub

Northway Biotech's U.S. facilities, located in Waltham, Massachusetts, provide integrated biologics development and manufacturing services within one of the world's leading biotech ecosystems.

Location

Boston: Center of Biotech Innovation

The Boston-Cambridge area is one of the most established biotech hubs globally, bringing together leading universities, innovative biotech companies, and major pharmaceutical players in a single ecosystem. Massachusetts employs over 140,000 people in the life sciences and consistently attracts a significant share of U.S. biotech venture funding. With nearly 1,000 biotech companies in the region, it offers exceptional access to talent, innovation, and partnership opportunities across the full drug development lifecycle.

140K+

Life-sciences jobs in Massachusetts

~1,000

Biotech companies in the region

~30 min

From Boston Logan Airport

2

Interchangeable EU & US sites
The Facility

Advanced Biologics Manufacturing & Development Facilities

Our Waltham facility, dedicated to protein-based biologics, provides a seamless, vertically integrated pathway from cell line development through cGMP manufacturing of drug substance and drug product. We offer the flexibility of both mammalian and microbial expression platforms, designed to support a broad range of recombinant proteins and monoclonal antibodies. Every project is underpinned by rigorous quality systems and integrated analytical workflows, supported by meticulous documentation to move your program forward with confidence.

10+

R&D laboratories

45 L - 450 L

Microbial fermenters

10 L – 2,000 L

Mammalian bioreactors (single-use)

cGMP MANUFACTURING

Drug Substance and Drug Product

FULL END-TO-END-SERVICES

ASEPTIC FILL & FINISH

Vials, Pre-Filled Syringes, Cartridges, Lyophilization

Our
services

Cell Line & Strain Development

Developing high-producing mammalian cell lines and optimized microbial expression systems.

Process Development (USP & DSP)

Developing and optimizing robust bioprocesses for scalable manufacturing.

Analytical Development

Development, qualification and validation of phase-appropriate analytical methods.

cGMP MANUFACTURING

cGMP drug substance / product manufacturing for clinical and commercial supply with scalable production capabilities.

Viral Clearance Studies

Early and late-phase VCS for validation of purification processes to ensure robust downstream performance.

Quality & Regulatory CMC Support

Integrated QA, QC, and CMC regulatory excellence from development through commercialization.

ONE PARTNER. TWO CONTINENTS. ZERO COMPROMISE.

Our EU and US sites operate as one, same capabilities, same standards, full regulatory flexibility.

2025 CDMO Leadership Awards — Global BiologicsOutsourced Pharma & Life Science Connect
2025 CDMO Leadership Awards Europe — BiologicsOutsourced Pharma & Life Science Connect