
ABOUT NORTHWAY BIOTECH
Northway Biotech is a biologics CDMO with FDA and EMA-compliant facilities in Waltham, MA, and Vilnius, Lithuania. Since 2004, we have completed over 175 mammalian and microbial projects for 90 global clients.
We offer a full range of services, including cell line development, upstream and downstream process development (USP & DSP), formulation, analytical methods development, and both clinical and commercial cGMP manufacturing of drug substances (up to 4,000 L for mammalian and 3,000 L for microbial processes) and drug products for recombinant proteins and antibodies.
Recently, Northway Biotech expanded into gene therapy with a new CDMO facility—the first building of the BIO CITY project, which aims to become the largest biotech hub in Europe. Our state-of-the-art infrastructure and expert teams deliver customized solutions to meet each client’s unique needs.
FEATURED ARTICLES
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High-quality process development aims to maintain a consistent process from toxicology through to GMP production runs, and can be aided by a capable, adaptable CDMO.
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A properly executed virtual audit facilitates thorough qualification, condenses production timelines, enhances relationship-building, and provides early insight into a CDMO’s capability and expertise.
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A principal concern of cell line determination is producing the desired protein in a considerable quantity. Understand the technical and regulatory considerations for microbial, mammalian, and yeast platforms.
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CDMO proposals often vary in level of detail and depth of explanation, preventing a lateral comparison. However, CDMO clients can take steps to ensure more uniformity between competing offers.
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Executing or skipping an engineering run is a consequential decision for any biopharma or CDMO and should be supported by all available data as well as a thorough risk assessment.
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While many drug developers and manufacturers have raced to bring vaccines to the market, others have struggled with the scarcity of supply created by an overwhelming demand for the same resources.
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Biopharmaceutical sponsors can minimize to-clinic timelines by using innovative development strategies that trade potentially increased risk for time savings.
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The way a CDMO responds to a request for proposal provides significant insight into how the CDMO will approach a long-term collaboration.
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Recognizing the increased complexity of biologic analyses, as compared to small molecule drugs, can help avoid unnecessary complications and prevent cost overruns.
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Pitfalls exist at every step when attempting to replicate a production process, whether a process is being scaled for commercialization, reproduced at the same scale at an additional site, or transferred to another CDMO. Learn the challenges associated with tech transfers and how to overcome them.
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Access to technical, process, and regulatory experts under one CDMO roof minimizes logistical and cost-related concerns for biopharmaceutical companies while offering them unprecedented control over production.
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This Q&A addresses attendee questions from a recent webinar about a new biomanufacturing site in Waltham, MA, equipped with state-of-the-art equipment.
CONTACT INFORMATION
Northway Biotech
828 Winter Street
Waltham, MA 02451
UNITED STATES
Contact: Virgilijus Kupinas
EU FACILITIES
Mokslininku str. 4
LT-08412 Vilnius, Lithuania