cGMP MANUFACTURING

Drug Product

Northway Biotechpharma supports the full biopharmaceutical value chain by offering aseptic fill-finish of drug product.

With flexible, state-of-the-art R&D and cGMP manufacturing facilities and strong staff expertise across all functions, we are exceptionally equipped to advance your biologic drug from lab to market.

We manufacture liquid and lyophilized sterile drug product into vials or syringes according to EMA and FDA requirements in a Grade A environment. Our fill-finish manufacturing line handles bulk frozen, liquid bulk frozen and liquid drug substance, with formulation activities performed on a separate line. Our filling machine fills up to 8,500 vials or 20,000 PFS per batch, and we can lyophilize at a rate of up to 4,200 vials per batch.

Whether we have collaborated on your product’s development from the start or are manufacturing drug product after a technology transfer, we have the flexibility, infrastructure and expertise to adapt our processes to align with the unique needs of your project.


Drug Product Manufacturing Capabilities

  • Fill and finish of sterile drug product into vials and syringes
  • Lyophilization of aseptic drug product into vials

Flexible, State-of-the-Art Manufacturing Equipment

  • cGMP washing machine
  • Sterilizer
  • Filling machine
  • Lyophilizer
  • Capping machine

cGMP MANUFACTURING

Cell Bank

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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cGMP MANUFACTURING

Drug Substance

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

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