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Process Development

From the earliest stages of development, we are wholly focused on your commercial success.

For biologics, in particular, this necessitates the implementation of robust and flexible processes that can be efficiently transferred and scaled up for production at all scales. Our flexible facilities with state-of-the-art equipment, combined with the expertise of our teams, enables us to efficiently advance your protein from concept to cGMP production – all under one roof.

At Northway Biotech, we have a long and successful history of developing processes that facilitate efficient and scalable production. Our R&D labs are staffed by experts in molecular biology, genetic engineering, bioengineering, biochemistry and biotechnology, all working together to determine the optimal path for your product’s development. This wide-ranging institutional knowledge is complemented by our flexible facility design and integrated upstream and downstream processes for enhanced efficiency and reduced risk.

We are also offering technology transfer to implement an existing production process from our clients in our facility for subsequent cGMP manufacturing.

Upstream Process (USP) Development

Our upstream process development group develops high quality and optimal yield during mammalian cell culture or microbial fermentation. Our approach is customized for the unique characteristics of your desired protein.

USP Capabilities

  • Optimization of media and feeding strategy at lab scale (0.2 L, 1 L, 3 L, 7 L, 15 L)
  • Small-scale qualification and process characterization studies
  • DOE experiments for yield and quality improvement
  • Scale-up and Confirmation runs (up to 200-L SUB)
From the earliest stages of development, we are wholly focused on your commercial success...

Downstream Process (DSP) Development

We develop customized purification processes for each therapeutic protein to facilitate a high production yield. This tailored approach, combined with applications of Design of Experiments (DOE), high-throughput assays and automated screening platforms, enables accelerated development timelines for clients.

Our downstream capabilities are flexible enough to align with the scale of the upstream process, allowing one USP batch to be purified in a single run without the need for sub-lotting. State-of-the-art equipment is used for development, optimization and scale-up of downstream processes.

DSP Capabilities

  • Harvesting (centrifugation, depth-filtration) and cell disruption
  • Isolation and solubilization of inclusion bodies followed by refolding of target protein
  • Protein purification in different scales using various chromatography techniques
  • Small-scale qualification and process characterization studies
  • Rapid technology transfer and scale-up to cGMP manufacturing scale
  • Purification can be accommodated at cold temperatures.


Cell Line Development

We offer the flexibility of both mammallian and microbial expression systems – and the expertise to develop the optimal call line for your product.

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Analytical Methods Development

Our in-house quality control team utilizes a variety of advanced technologies to optimize your protein's critical quality attributes.

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Formulation Development

From the earliest stages of development, we are committed to ensuring the long-term safety and efficacy of your product in the finished dosage form.

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