Process Development

We offer complete services from upstream to downstream operation for the development of your therapeutic proteins.
With the aim to develop a well-defined, scalable, reproducible and commercially viable process, we can offer the best platform to link your discovery to market.

PROCESS SCREENING & OPTIMISATION
The Process Science team has the expertise and experience in developing and establishing processes for successful biomanufacturing.
The development encompasses selection of process strategy and optimisation in three major operations namely cell culture; separation and filtration; and purification.

Cell Culture
Development using different modes of bioreactor operation such as batch, fed-batch or perfusion strategyPerfusion study using external spin filter technologyProcess parameter optimisation of bioreactor operation to achieve maximum product expression

Separation and Filtration
Process development using various modes of operation; dead-end filter or tangential flow filtration through membrane cassette or hollow fibre configurationVirus filtration using various filter types and configurationVirus inactivation by means of heat and chemical treatmentProcess parameter optimisation, to maximise product recovery.

Purification
The team will develop the strategy and sequence for the purification based on the understanding of your product and other contaminants profile.Development of strategy and chromatographic sequence in order to achieve the specified recovery and final purity requirementsWide range of chromatography media screening for each chromatography stepProcess parameter optimisation in each chromatography step to achieve the highest possible recovery and purity.

PROCESS SCALE-UP AND TECHNOLOGY TRANSFER
Focus will be given to ensure reproducible and robust process to serve manufacturing scale requirements.
Cell culture scale-up work from bench top bioreactor to pilot scale (at 20L and 100L scale)
Scalable filtration activities using pilot scale system for cell separation and product concentration operations.
Scale-up activities for purification operations using pilot chromatography system and linear scale-up of column capacity.
Process verification to establish procedures and specifications with detailed documentation and reportTransfer of process specification and product information for production scale operation.

PRE-CLINICAL PRODUCTION
The team can help you to advance your product development from pre-clinical non-GMP pilot scale production in our development suite. The services include:
Rapid development of reproducible and scalable process for production of pre-clinical material.
Supporting services including comprehensive analytical testing to ensure product safety and compatibility.

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