Accelerating innovation in Biologics manufacturing

The UK’s National Biologics Manufacturing Centre

CPI aims to accelerate and enable your biotherapeutic by supporting the design, development, optimisation and demonstration of bespoke manufacturing processes specific for your product. 

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We have worked with a wide-range of organisations from across the world including large multinational corporations, small-medium enterprises and start-up companies as well as internationally renowned universities.

We are a UK government backed, independent facility with no alignment to proprietary technologies or contract manufacturing lock-ins – meaning the processes that we develop with you can be transferred to your manufacturing site or a CMO of your choice. Our work is ISO 9001 certified for scale-up and manufacturing approaches.

Our capabilities

We are happy to work with you on discrete process challenges or on complete development campaigns to produce material for pre-clinical and/​or toxicology studies. Our experienced team of scientists, engineers and project managers can support you with a comprehensive suite of services and expertise, including:

  • Microbial and mammalian cell culture optimisation at both lab and pilot scale
  • Bespoke downstream process development
  • Analytics for process characterisation and final testing
  • Fill, finish, formulation, cryopreservation development
  • Forced degradation and stability studies 
  • Cell-free protein synthesis 
  • Continuous processing

Our state-of-the-art facilities at our Darlington, UK site, comprise 13 BSL1 and BSL2 flexible laboratories which allow us to develop cost-effective GMP compliant processes. We utilise specialised scaled-down and high-throughput systems to accelerate the development and optimisation of your bioprocesses before scale up to maximise the yield, purity and quality of your product.

On this page

    Enabling innovation

    We can help you overcome challenges in biologics manufacturing, providing a bespoke solution that is agnostic to platform and technology. We drive innovation in product, processing and manufacturing technologies for challenging biotherapeutics.

    We offer manufacturing solutions for microbial and mammalian expression systems and a wide range of products; including monoclonal antibodies, viral vectors, recombinant proteins, microbial therapeutics and nanomedicines. 

    We can help you with...

    • Viral Vectors
    • Vaccines
    • DNA/RNA
    • Recombinant proteins
    • Nanomedicines
    • Monoclonal antibodies
    • Microbial therapeutics

    Get in touch

    Want to speak to a member of our team?

    Contact us
    Sam Neill

    Sam Neill

    Business Development Manager

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    Strain characterisation and cell banking

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    We can assist in microbial strain cloning, selection and characterisation of a range of species, including E. coli, S. cerevisiae, B. subtilis, as well as carrying out purity and plasmid stability testing. We can also carry out characterisation of mammalian expression platforms, including CHO, HEK293, MDCK, MSCs, iPSC etc. 

    We areable to test the suitability of these cell lines for scale-up and commercial applications and can create non-GMP master and research cell banks for development work and can provide temporary or extended storage for security. 

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    Strain Characterisation 

    • Strain characterisation for a range of microorganisms and mammalian cell lines.
    • Testing suitability for scale-up and commercial applications.

    Plasmid Vector Design 

    • Assistance in plasmid vector design for transient and stable applications.

    Cell Banking 

    • Cell banking for non-GMP master and research cell banks with access to 80oC and cyrostorage.
    • For viral vector applications, we can also carry out viral seed banking.

    Upstream process development and optimisation

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    Our dedicated mammalian process development capabilities covers a wide range of commonly used cell lines and stem cells, including CHO, HEK293, MDCK, MSCs, iPSC etc and we have the ability to carry out adherent, microcarrier and suspension cell culture processes for the production of recombinant proteins, antibodies and exosomes. We also have expertise in the production of viral vectors, including AAV and lentivirus for the development and scale-up of targeted therapies.

    Our microbial process development includes experience in handling a wide range of microganisms, such as E. coli, S. cerevisiae, B. subtilis and many more to suit your particular project requirements. We have expertise in the expression of recombinant proteins and working with VLPs, phage, spores and plasmids.

    We also have experience with in-vitro transcription for the production of mRNA products and cell free expression of recombinant proteins, including difficult to express proteins, as well as including reaction scale up.

    We have also had successful experience of transient transfection to produce biologics in both CHO and HEK293 systems by chemical transfection or electroporation, including monoclonal antibodies which provides an effective approach to getting early access to molecules in development. 

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    Process screening and optimisation 

    • Statistical DoE and scale down modelling.
    • Multi-parallel small-scale bioreactors to rapidly define critical process parameters on ambr15cc and ambr250 systems.
    • High throughput media and feed screening.

    Lab scale demonstration 

    • Scale-up evaluation.
    • Method refinement and robustness testing. 
    • Continuous processing.
    • Process analytics for cell viability and metabolite analysis.

    Process scale-up 

    • Process demonstration.
    • Scale-up studies.
    • Material supply.

    Downstream process development and optimisation

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    We have a wide range of experience working across microbial expressed recombinant proteins and mammalian expressed proteins such as monoclonal antibodies, viral vectors, nanoparticles, exosomes and mRNA vaccines. Our typical downstream workflow commences with high- throughput, small scale screening moving onto process development and optimisation and process scale-up and demonstration.

    Our approach is based on using scale down equivalents of key unit operations to identify the leading process candidates through high throughput process screening. These lead process candidates are evaluated at bench scale to define a robust manufacturing process which is then scaled up to demonstrate consistency across scales.

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    Primary separation, cell disruption and supernate concentration 

    • Cell harvest and centrifuge
    • Homogenisation
    • High-throughput sonication
    • TFF flow-path systems
    • Media and feed screening

    High throughput process screening and optimisation 

    • Scale-down models
    • Chromatography and filtration media screening
    • Scouting process conditions

    Process scale-up 

    • Demonstration of the scaled-up purification process
    • Material supply

    Lab scale demonstration 

    • Evaluation of lead process candidates, method optimisation and refinement
    • Robustness testing
    • Continuous processing
    • PEGylation and conjugation

    Analytic measurement and characterisation

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    We can provide you with a wide range of analytical services for biotherapeutic characterisation. These services are tailored to your needs, allowing us to support your analytical development and testing requirements. We have experience with characterisation of a diverse range of products including glycosylated and non-glycosylated proteins, monoclonal antibodies, viral vectors, nucleic acids and nanomedicines.

    Through our suite of analytical resources, we can support you in developing analytical methods for a variety of products and are also able to offer RNA sequencing analysis using next generation sequencing (NGS) to investigate the transcriptomic profile of cells. This offers insights into cell culture performance during process development.

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    Viral vector product characterisation 

    • Total particle titre
    • Genomic particle titre
    • Infectious particle titre
    • Purity
    • Aggregation

    Identity, purity and aggregation 

    • Assessing residual process impurities
    • Assessing mispackaged DNA media screening
    • Assessment of aggregation levels across the nanometre, submicron, micron and visible size ranges

    Stability testing and structural characterisation 

    • Fluorescence based glycan profiling
    • Mass spectrometry for intact and subunit mass determination, peptide mapping, N Glycan profiling and determination of site specific modifications

    Formulation development and stability assessment

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    We can support forced degradation and stability studies to characterise the effect of storage conditions on your product. We offer a number of fill, finish and lyophilisation options for a wide range of products.

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    Fill and finish 

    • Non-GMP aseptic manufacturing procedures.
    • Ability to develop and test vial-based fill and finish methods to understand filling stresses.

    Forced degradation and stability studies 

    • Freeze-thaw studies.
    • Storage studies covering room temperature, 4°C, ‑20°C and ‑80°C.
    • Controlled light exposure.
    • Oxygen and pH exposure.

    Cryopreservation and formulation development 

    • Freeze drying and lyophilisation.
    • Ensure product quality with high-throughput formulation optimisation.

    Get in touch

    Want to speak to a member of our team?

    Contact us
    Sam Neill

    Sam Neill

    Business Development Manager

    Connect

    IS0 9001