With our PhenoStart™ Lite process we can evaluate protein expression in as little as 6 weeks. If this is positive, we move into a full feasibility PhenoStart™ for a further 10 weeks. We will establish if we can make the protein effectively and what titre and broad quality we can aim for.

    Positive results from the PhenoStart™ stage could lead into a PhenoDev™ project which can take up to 35 weeks depending on the protein and complexity. We are aiming to produce the optimal industrial production strain to go into fermenters. At the end of the service, you will be provided with an animal free R&D cell bank of 3-6 strains and associated plasmids optimised strains for use in your further downstream process development either in-house or with a CDMO of your choice. We can provide additional technology transfer to a CDMO, or you can progress to our PhenoFull™ service.

    PhenoFull™ can be used to develop your specific process for low-cost protein production. You will get an R&D scale process description for subsequent scale-up, validated for yield in industrially relevant fermentation conditions using animal-free media and with cell separation, purification and quality attributes designed for cGMP manufacturing. Final formulations could also be generated for stability testing and some pre-clinical work. The nature of this ‘campaign’ style of work means that it is difficult to define exact timelines, but typically this could range from 50-75 weeks.

    • PhenoStart™

    • PhenoDev™

    • PhenoFull™

    • PhenoStart™ is a feasibility study for secreted or intercellular proteins. Taking a secreted protein as an example, the high-level approach would be the following.

      • PhenoStart™ Lite assesses your protein in our key strain library within 5-6 weeks
      • The PhenoStart™ Feasibility study widens the scope of assessment to our genetic diverse strain library and gives you an indication of titre, quality and identity of your product within a further 6-8 weeks
      • Data collected during PhenoStart™ will inform the decision to proceed to PhenoDev™
    • If the results from the PhenoStart™ are promising, we can proceed to PhenoDev with the following high-level activities:

      • We start a full breeding programme to obtain >1 billion genetically diverse progeny and screen for the highest producers of your protein (>1 billion can be screened in a matter of hours - the aim is to fail fast)
      • We select the best 1,000 strains for further work in microtitre plates and shake flasks.
      • The top 100 are assessed for quality and quantity of protein produced in small stirred tanks after purification via ÄKTA™ pure
      • At this stage, our toolbox of targeted engineering approaches and further screening improves product quality. Proteases, O-glycosylation and poor protein folding can be addressed in the best strains
      • The very best producing strains are put in 10-litre scale fermentors configured to replicate large-scale manufacturing to evaluate fermentation characteristics
      • We perform analytical testing of purified supernatants based on the process methods and matrices given to us by the customer or developed by us
      • We calculate the volumetric productivity of your protein at a defined and achievable quality level

      At the end of PhenoDev™, clean working and master cell banks will be available for process use by the customer in their facilities, or to be transferred to their chosen CDMO

    • Strain development for contract manufacture is provided by the PhenoDev™ programme. Subsequently a bespoke PhenoFull™ service provides a full process definition for in-house or contract manufacture. We address downstream, fill/finish and analytical method development needed for full process definition. We can work with your or our CDMO partners and our extensive downstream processing team to develop your process in 12-18 months, depending on the target protein and your current procedures. The total development cycle can be compressed by overlapping upstream process development in PhenoDev™ and downstream process definition in PhenoFull™.

      Our in-house group has further expertise in chromatography purification, assay and final formulation development, cell separation and filtration. We also have experience with the latest analytical methods and product quality measurements.

    Get In Touch

    If you have any questions, or would like to find out more about our unique processes, please get in touch.

    Office Address

    Phenotypeca Ltd, BioCity Nottingham, Pennyfoot Street, Nottingham, NG1 1GF.

    Email: info@phenotypeca.com

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