Mammalian Development

Mammalian Upstream Development (USP) Services 

The objective of cell culture process development is to produce a robust and scalable process for the initial culture and production culture fitting within SynCo’s production facilities while maximizing productivity. Preferably a target product amount is agreed before development work is started to assess the practical and economic feasibility of the developed process. 

Various production methods for mammalian based products, such as batch, fed-batch, repeated batch and perfusion are well established at SynCo. 

SynCo’s mammalian production organism experience includes:

• CHO cells
• PER.C6® cells
• Pichia pastoris

Our core competencies in mammalian USP development using 20 – 200 L Wave bioreactors are:

• Full cell culture development
• Optimization of developed cell culture processes
• Development of feed strategies
• Development of perfusion process
• Development of primary recovery
• Process characterization (part of process validation)

Mammalian Downstream Development (DSP) Services

An effective DSP strategy is critical to delivering a robust and scalable process, with appropriate quality and acceptable cost. The different properties of the molecules produced and the environment from which they are to be purified mean that each process is unique with its own challenges. 

The development of the downstream process will start with the understanding of physicochemical properties of the product molecule. SynCo exploits these physicochemical properties to quickly understand the feasibility of certain purification methods and consequently reducing the number of options to be investigated experimentally. After theoretically narrowing down the options, experimental works will be carried out to investigate the purification techniques that are highly likely to be efficient for this product molecule. At SynCo, this approach has been found to be efficient and minimizes the experimental effort and consequently shortens the downstream process development timelines.

Our core competencies in mammalian DSP development are:

• Selection of membrane technologies
• Chromatography
• Affinity
• Ion exchange
• Size exclusion/ gel filtration
• Hydrophobic interaction/reversed phase
• Gradient purification
• Viral clearance
• Centrifugation
• Protein modification (chemically, enzymatically)

If you are interested in learning more about SynCo's process development services, please do not hesitate to contact us or to download our factsheet.