Process Development

Our approach to process development emphasizes Quality by Design from the outset. We work with our clients to fully understand the product concept and record this in a Quality Target Product Profile (QTPP). From the profile, we work to develop a process and an associated control strategy to ensure our clients products and processes can be relied upon to be robust, stable and suitably designed for future scale-up. Our manufacturing processes emphasize the use of fully enclosed, single-use systems for both buffers and process intermediates which help ensure highly sanitary production conditions throughout manufacturing. This helps to protect both your product and our colleagues and is a distinct area of focus for regulatory authorities.

We have extensive experience in development of fermentation, product recovery, refolding, chromatography, filtration, tangential flow and hollow-fiber filtration operations and the necessary development and manufacturing facilities to seamlessly scale-up these operations from laboratory bench to full commercial production scale.

Our knowledge and experience of managing products through the development lifecyle of pre-clinical, clinical to final commercial launch ensures we understand the broad range of studies required and the appropriate time and project phase at which to complete these studies.