Commercial Manufacturing Process Intensification Solutions

N-1 perfusion high inoculum fed-batch is a logical first step toward intensification.

With development cost increasing more than 30% and sales falling by 50%, staying competitive requires increasing productivity of your facility to reduce overall COGs. Intensifying the seed train, especially the N-1 step, is one of the most trusted and logical approaches that you can implement.

1. Up to 2X higher titer and as much as 50% increase in throughput
   N-1 perfusion can double titer, reduce upstream processing time, and increase throughput by 20% to 50%.
2. Increased throughput outweighs additional media investments
   Thanks to increased throughput, the impact of additional media requirements on costs or facility setup is negligible.
3. Easy retrofit existing facilities
   N-1 supports easy retrofitting for existing fed-batch facilities without changing the fed-batch strategy in the main bioreactor.
4. Lower COGs compared to fed-batch
   With higher throughput and increased productivity, N-1 perfusion reduces cost per gram by 30% to 50% compared to traditional fed-batch. 

Concentrated fed-batch is the upstream process intensification approach that can have the greatest impact on productivity compared to standard fed-batch, producing up to 4X titer and 3X-4X higher throughput. Concentrated fed-batch is the ideal option for converting stainless steel to single-use operations and for blockbuster drugs. The industry is trending toward throughputs below 500 kilograms per year, and concentrated fed-batch offers the flexibility needed to support a high-throughput, single-use, multi-product facility.

1. Up to 3X-4X higher titer
   Concentrated fed-batch enables higher viable cell densities in the production bioreactor, resulting in up to 4X increase in product titer compared to fed-batch.
2. Enables efficient multiproduct facilities
   Concentrated fed-batch increases throughput by up to 3X, creating the flexibility needed for high throughput facilities to meet market demands.
3. Facilities transition from stainless steel to single-use
   With a smaller footprint, single-use facilities are more sustainable, and offer greater adaptability and flexibility. 

To increase productivity across different modalities including difficult-to-express molecules, established manufacturers are looking to single-use, flexible solutions when building new facilities or modifying existing operations. Meanwhile, early-stage drug development companies are looking for low upfront investment for their lower throughput products. With smaller bioreactor requirements that deliver higher productivity per batch, dynamic perfusion can be the solution to both challenges.​

1. Enables small footprint for next-generation modular facilities
   By enabling up to 5X higher volumetric productivity, dynamic perfusion accelerates build-up times by supporting a modular approach and smaller bioreactor sizes.
2. Achieves up to 5X volumetric productivity
   Dynamic perfusion enables 2-5 g/L per day with continuous harvest of product over 2 weeks, achieving up to 5X higher productivity than fed-batch.
3. Ideal for sensitive modalities
   Continuous harvest ensures optimal product stability and quality, which is critical for unstable molecules prone to degradation.