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Capabilities

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Explore our capabilities

The highly experienced CPI team can help guide you from concept to finished product. We have scientists, engineers, scale up experts, process technologists and commercialisation specialists to take your project from early concepts through to robust manufacturing process packages and products.

Our services can be customised to meet your needs wherever you are in the development process and supply chain. We are delighted to work side by side with our clients to help them overcome the challenges of commercialisation of their products and processes. Our extensive industry experience means we can make recommendations accordingly in an effort to produce the best possible outcome.

We welcome all enquiries about our capabilities and equipment. It is our mission to help customers and partners maximise the potential of their products, accelerate speed-to-clinic and help reduce cost-of-goods. We pride ourselves on meeting our deliverables and adding considerable value to our partners’ and customers’ products and processes.

We offer capability in the following areas:

  • Upstream Processing
  • Downstream Processing
  • Analytical Testing and Development
  • Fill and Finish
  • Manufacturability, Process Modelling and Simulation
  • Process Economics and Evaluation
  • Commercialisation and Business Support including IP Landscaping
  • Public – Private Project Funding Support
  • Bespoke Training Packages
  • Upstream Processing

    We have upstream laboratory facilities equipped with state-of-the-art technologies to support the development, demonstration and scale-up of bioprocesses.

    The micro-Matrix and ambr250 mini bioreactors allow scale-up, high-throughput evaluation and optimisation of critical process parameters. Optimised processes can be scaled-up and demonstrated at laboratory and pilot scale.

    Our work is supported by a range of static and shaking CO2 incubators for flask culture. We have a Roche CEDEX HT bioanalyser, COBAS blood gas analyser, ViCell™ automated cell counters and osmometers for in-process sample measurements. We also have -80°C freezers and liquid nitrogen cryobanks for long term storage of cell lines.

    Upstream processing activities cover both mammalian and microbial cells as detailed in the respective sections.

    Mammalian

    Mammalian cell culture capabilities are focused on the use of customer and partner supplied cell lines to produce and optimise the production of a wide range of biopharmaceutical products, recombinant therapeutic proteins and attenuated viruses (eg AAV).

    Microbial

    Microbial capabilities are based on the use of a variety of microbial systems for the production of recombinant proteins (soluble and insoluble).

    Combined service offering

    • Establishment and storage of research cell banks
    • Cell line/strain screening and evaluation
    • Development of robust and scalable processes using QbD and DoE approaches
    • Production and supply of pilot scale materials for downstream process development, analytical testing or other non-GMP studies
    • Development of process models
  • Downstream Processing

    Our downstream capabilities are focused around the development and optimisation of manufacturing ready processes for a variety of product types.

    Examples of products encountered include recombinant therapeutic proteins, attenuated viruses (eg AAV), PEGylated proteins and complex biological nanopharmaceuticals. For microbial processes, purification can be optimised for both soluble products and those refolded from inclusion bodies.

    Our flexible facilities are appropriately equipped to allow for both lab and pilot scale purification. We have high throughput screening capabilities based on the use of automated liquid handling work stations. We have developed methods for rapid experimental design that integrate with automated methods for high throughput investigation and development of downstream unit operations such as protein refolding, precipitation and chromatographic purification. Integration with high throughput process development analytics, such as the LabChip® GXII, enables rapid analysis of product quality and yield.

    By using lab scale equipment such as tangential flow filtration (TFF) and traditional or continuous chromatography systems, unit operations can be scaled for further optimisation or exploration of design space. Systems can be used as standalone operations or integrated, with options for gravimetric quantification, temperature regulation and highly efficient mixing, to allow for semi-automated processing and analysis. We also have industry standard capabilities for semi-automated and fully automated pilot scale process demonstration including separations, normal flow filtration, depth filtration, microfiltration, tangential flow filtration and chromatography unit operations. Our singleuse capabilities allow for disposable processing, including temperature regulated mixing systems and flexible filtration.

    Service offering

    • Development of robust and scalable processes including the following unit operations:
    • Primary separation/recovery steps (eg cell broth clarification, cell disruption, inclusion body recovery, protein folding, precipitation, depth filtration)
    • Filtration – normal flow (NFF) and tangential flow (TFF)
    • Chromatography (batch and continuous)
    • Conjugation or protein modification (eg PEGylation)
    • Unit operation or full process scale–up for demonstration at laboratory or pilot scale
  • Analytical

    Analytical science underpins almost all aspects of biopharmaceutical development and manufacture and we ensure the latest developments in analytical science are translated into our customer’s projects.

    Our extensive analytical suite supports investigation and optimisation of the various stages of biopharmaceutical development and manufacture, helping to optimise product yield and quality. We provide comprehensive characterisation of product quality attributes such as glycan profile, levels of aggregation, secondary structure and charge variant profile as well as high throughput screening of product purity, titre and impurity clearance throughout downstream processing.

    We have Ion Torrent™ next generation sequencing capabilities to allow a genomics based approach to biopharmaceutical process optimisation, helping to identify important cellular features related to the performance of cell lines. CPI is also equipped with a Waters Synapt G2Si mass spectrometer to allow peptide mapping and comprehensive characterisation of post translational modifications, plus hydrogen deuterium exchange for higher order structure studies.

    In addition to applying our state of-the-art analytical tools to research and development projects, we also perform routine bioanalysis (cell count/viability, nutrients, metabolites, product titre, and product characterisation); stability testing; characterisation of reference standards; comparability testing (purity, potency and identity); method development, verification and transfer.

    Service offering

    • Purity and identity measurements
    • Impurity measurements
    • Potency and higher order structure
    • Formulation and stability studies including comprehensive characterisation of aggregation
    • Development of process specific analytical methods
    • Process analytical technologies
    • Product characterisation
    • Molecular characterisation
    • Method development
    • Method transfer and verification
  • Fill and Finish

    Our Fill and Finish capabilities are focused on improving the sterile filling, finish and lyophilisation of biologic drugs.

    Service offering

    • Handling a wide range of products (eg proteins, vaccines, DNA and viral vector solutions, viscous biopolymers and other nanoparticles)
    • Filling volume ranging from 0.2-250ml
    • Filling of up to 120 vials per hour
    • Flexible bulk volume up to 20L
    • Batch Lyophilisation covering: development of lyophilisation cycles in vials, flasks and bulk volumes; development and optimisation of multi-step lyophilisation cycles
Explore our capabilities