DEVELOPMENT SERVICES

Formulation Development

Northway Biotechpharma has the expertise and infrastructure to formulate and manufacture aseptic drug product at a range of scales.

No matter the complexity of your protein, our expert teams will develop a solution that optimizes its efficacy in the finished form. We provide formulation development services for liquid and lyophilized drug product, in vials or prefilled syringes.

Once the optimal excipients have been selected, we perform stability studies according to ICH guidelines as well as applying a number of stability-indicating methods to ensure the long-term safety and efficacy of the product.


Formulation Development Capabilities

  • Scouting by stress and accelerated stability studies
  • Estimation of product’s shelf-life by long-term stability programs
  • Development of drug product formulation for fill-finish at pilot scale
  • Development of specifications for both drug substance and drug product

DEVELOPMENT SERVICES

Cell Line Development

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

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DEVELOPMENT SERVICES

Process 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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DEVELOPMENT SERVICES

Analytical Methods 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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