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PD and cGMP Facilities

Northway Biotech Facilities are located in Waltham, Greater Boston area of Massachusetts, one of the major biotechnology hubs in the United States.

Modern and Automated Facilities

Our brand new, state-of-the-art facilities include R&D labs for cell line development, USP and DSP processes establishment, and analytical support. cGMP manufacturing site with both single-use and stainless steel systems for upstream and downstream process development, formulation, and fill-finish of microbial and mammalian cell culture-based products. Flexible design with integrated infrastructure enables us to develop, formulate, and manufacture clients’ proteins and antibodies quite fast while aseptic drug product manufacturing capabilities allows adding value to customer project from timelines and cost perspective.

The microbial production line consists of 30 and 300 L fermenters and the mammalian line comprises various single-use bioreactors ranging from 10L to 2000L, with the possibility to expand capacity with a second 2000L bioreactor.

We are a 30 min drive from the Logan International Airport, which can be easily accessed from all major US cities and many international locations.


Process Development

Our R&D experts work with you to develop processes that can be efficiently transferred and seamlessly scaled up for production.

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Drug Substance

With industry-leading expertise and state-of-the-art single-use equipment, we can take your drug substance from concept to commercialization, all within our modern facilities

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Quality Control

Our QC labs and Grade A, B, C and D cleanrooms for biological and sterility testing enable the full evaluation of product identity, potency, quantity, purity and any process-related impurities.

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Quality Control Equipment

  • HPLC (Waters)

  • RT-PCR (Applied Biosystems)

  • Capillary electrophoresis (Beckman Coulter)

  • Absorbance plate reader (Tecan)

  • UV/Vis spectrophotometer (Implen)

  • Analyser of sub-visible particles in liquids (Particle Measuring Systems)

  • Automated cell culture analyzer (Roche)

  • Sterility testing equipment (Millipore)

  • Membrane filtration equipment for bioburden testing (Millipore)

  • Automated titrators (Metrohm)

  • Immunoassays equipment

  • Constant climate chambers (including photostability) for stability studies according ICH (Binder)

  • Environmental monitoring equipment