Our team of experts has more than 35 years of experience in microbial-based process development. We offer development of manufacturing processes that can be scaled up to clinical and commercial scales without compromising on product quality.
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.
Process Development Equipment and Technology:
1L – 20L fermenters
Parallel fermentation in up to 8 bioreactors at 400 mL – 1L scale for rapid process characterization and optimization
Homogenization and refold development
Purification: AKTA™ avant, AKTA™ pilot, and AKTA™ Explorer for development of scalable chromatographic purification processes
Tangential Flow Filtration: AKTA™ CrossFlow for filtration process development using QbD methodology