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DEVELOPMENT SERVICES

Process Development

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

We implement robust and flexible processes for biologics, pDNA, AAV, AV, and LV vector production, ensuring efficient transfer and seamless scalability across all production scales. At Northway Biotech, our state-of-the-art equipment and flexible facilities, combined with our team’s extensive expertise, allow us to seamlessly advance your product from concept to cGMP production — all under one roof.

We have a long-standing history of successfully developing scalable processes for efficient production. Our R&D labs are staffed by experts in molecular biology, genetic engineering, bioengineering, biochemistry, and biotechnology, all working in synergy to determine the optimal development path for your product. This institutional knowledge is complemented by our adaptable facility design and integrated upstream and downstream processes, ensuring enhanced efficiency and reduced risk.

We also offer technology transfer services to implement your existing production processes in our facility for subsequent cGMP manufacturing.

 

Upstream Process (USP) Development

Our upstream process development group specializes in developing high-quality and optimal yield processes during mammalian cell culture, microbial fermentation, pDNA production, and viral vector manufacturing. Our approach is tailored to the specific requirements of your desired product, ensuring efficient, scalable, and robust processes.

USP Capabilities

  • Process Development: Biosynthesis parameters screening for improved production efficiency

  • Media and Feeding Strategy Optimization: Tailored strategies for nutrient delivery to maximize yield

  • Productivity Improvement: Enhancing process efficiency and output

  • Small-Scale Qualification and Process Characterization Studies: Ensuring scalability and reproducibility

  • Scale-Up and Confirmation Runs: Including toxicology and pilot batches (up to 200 L SUB)

  • Process Development for pDNA and Viral Vectors: Specialized development for scalable production of pDNA and viral vectors, optimizing transfection and ensuring high titers and product quality

 

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

Downstream Process (DSP) Development

We develop customized purification processes for biologics, pDNA, and viral vectors to facilitate high production yields. This tailored approach, combined with the application 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 a single USP batch to be purified in one run without the need for sub-lotting. We use state-of-the-art equipment for the development, optimization, and scale-up of downstream processes to ensure efficiency and high-quality outcomes.

DSP Capabilities

  • Process Development: Customized purification processes for biologics, pDNA, and viral vectors to optimize yields and product quality
  • Process Optimization: Enhancing purity, reducing costs, and improving processing time for biologics, pDNA, and viral vectors

  • Rapid Technology Transfer & Scale-Up: Efficient transfer from development to cGMP manufacturing scale, ensuring a seamless transition

  • Formulation Development: Liquid and lyophilized formulation strategies for biologics, pDNA, and viral vectors

  • Small-Scale Qualification and Process Characterization Studies: Ensuring reproducibility, scalability, and performance for biologics, pDNA, and viral vectors

  • Viral Clearance Studies: Assessing and ensuring viral safety in biologic, pDNA, and viral vector products

DEVELOPMENT SERVICES

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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DEVELOPMENT SERVICES

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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DEVELOPMENT SERVICES

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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