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What are the first steps in working with Newcells?

The first step is to contact one of our Account Managers who will give you an overview of our assays. If you wish to proceed, you will be introduced to the Technical Team. The Technical Team will take you through the process of study design and generate a Scope of Work (SOW). The scope of work presents the details of the study including deliverables and estimated timescales. At this point the Account Manager will send the final SOW and Quotation for the Study. If the SOW and price are agreed, the project will be assigned a Study Manager, an experienced laboratory scientist who will run the study and be your point of contact throughout the study. At the end of the study, the Study Manager will collate the results and the report.

Can we be involved in the design of the study and the report?

Absolutely! Study design is a joint endeavour between your scientist and the Study Director and Study Manager at Newcells to produce the best study to answer your questions. Our experienced scientist may be able to guide you to the best solution with input from the client at every stage. Similarly, we can customise the report to your requirements and format.

Can I receive updates on progress through the course of the study?

Yes, communication is very important. We will keep you informed as we progress. Before we send results, we will perform a QC of the data and results. Equally, the Study Manager is available for teleconferences to discuss any ongoing study.



What is the cellular composition of the organoids

Retinal organoids contain major retinal cell types found in vivo. The differentiation process follows the developmental timeline of retinogenesis in vivo and cell types are arranged in stratified layers of the neural retina.

Are the organoids functional?

Yes, the organoids are light responsive.

Do you observe variability among retinal organoids?

We have standardised the retinal organoid manufacturing process and introduced a quality management system to ensure the process meets strict criteria. A degree of variability is expected in any biological system; however, all our organoids undergo rigorous quality controls to ensure experimental reproducibility.  Only batches that have passed our quality control are released to our clients.

Have you performed transcriptomics analysis of your retinal organoids?

Yes, we have proprietary transcriptomic data from retinal organoids at day 150 and day 200 of differentiation.

Can retinal organoids be ordered at different ages e.g 60. 120, 150, 180 and 210 days?

Our off-the-shelf offering of organoids as a ready-to-use assay is at day 150 of differentiation but this can be customised for other time points to fit your requirement from day 60 to day 210.

What are the phenotypic differences between retinal organoids from d30, 60, 90, 120, 150?

Retinal organoid differentiation process closely follows the developmental timeline of retinogenesis in vivo. Therefore, various cell types are on a different developmental trajectory. Transcripts for retinal ganglion cells are most abundant at day 60 of the differentiation, however photoreceptors mature at later stages and beyond day 150.

Do retinal organoids contain RPE cells?

Retinal organoids do not typically contain RPE. We offer a separate service for RPE, please contact us for more details.

Can we order live RPE cells?

We currently offer RPE cells as part of a service which can be tailored to various customer needs. We are planning on offering RPE cells as a product in the near future.

Can you co-culture retinal organoids and RPE?

We currently do not co-culture RPE cells with the retinal organoids. However, we can carry out studies using retinal organoids and RPE cells as two separate models.

Do you offer models of retinal diseases?

We are able to offer CRISPR-Cas9 generated iPSC lines specific for your project needs. We are also working towards having a bank of cell lines available.

Can we develop retinal organoids or RPE cells with specific mutations?

We can generate retinal organoids or RPE cells from customer iPSCs bearing a mutation. If the iPSCs are not available, they can be derived from patient cells or generated using CRISPR-Cas9 gene editing. We offer both reprogramming and gene editing service.

What is the best cell line to use for gene editing?

We recommend to use our wild-type (WT) qualified iPSC line to make any genetic modifications.

How long does it take to develop disease model organoids with a specific mutation?

Generation of CRISPR-Cas9 iPSC lines takes 12-30 weeks depending on the editing complexity required. Generation of retinal organoids takes an additional 26 weeks for day 150 organoids.

Do you offer vector design?

We develop in vitro retinal assays for various applications and do not have capabilities for vector design. However, we have experience in working with gene therapy vectors through multiple customer and collaboration projects using our models.

Can you isolate the cell types in the retinal organoids and study them individually?

We do not offer individual neural retinal cell types as a stand-alone product. However, we are able to provide scRNAseq of retinal organoids as a service to allow analysing separate cell populations, please contact us to discuss your specific project needs.

How long do retinal organoids last?

Standard retinal organoids are sold at day 150 of the differentiation, however depending on the application and project requirement they can be used at later stages. Earlier stages organoids can be kept for longer periods. Please contact us for more information.

Can the organoids be used for evaluating the efficiency of gene therapy vectors in vitro?

Yes. Please refer to our recent publication where we assessed a broad range of transgene and capsid variants of AAV vectors. McClements et al. Transl Vis Sci Technol. 2022 Apr 1;11(4):3. doi: 10.1167/tvst.11.4.3.

Do you have data about the efficiency of transduction of iPSC derived retinal organoids using AAV?

Transduction efficiency is difficult to quantity in a complex multicellular model such as the organoids, and it varies depending on the AAV serotypes. In a collaborative paper, transduction efficiency has been evaluated by co staining of cell specific markers and transgene and transduction efficiencies of up to 37% have been achieved.

Mc Clements et al,(2022)  Transl Vis Sci Technol.;11(4):3


What are the capabilities of modelling more complex diseases such as AMD?

We can provide a RPE model which can potentially mimic early and dry forms of AMD.


How do you ensure that your organoids are 'ethically sourced'/ from ethically sourced donors?

The organoids are generated from iPSCs that were reprogrammed from human dermal fibroblasts obtained from healthy donors who provided full consent following formal ethical approval processes.


Can you ship retinal organoids globally?

We are currently able to ship live retinal organoids to Europe and the USA.

Retinal organoids are also available as frozen pellets ready for RNA extraction or as frozen sections for immunostaining worldwide.

How do you ship your organoids and RPE?

Retinal organoids are shipped live in 5 ml tubes containing 10 organoids each. In addition, we provide 150 ml of optimised cell culture medium and 2 x 96 well plates per 100 organoids, plus 2 x Pasteur pipettes for transferring them.

Does the time in transit affect organoid viability?

We have validated our shipment process for up to 7 days in transit, which is standard for all of our North American shipments.

How can we check for the quality of the organoids upon receipt?

All our organoid batches sold at day 150 of the differentiation have passed our quality control. In addition, our shipment processes have been validated. If you have any concerns, one of our technical experts will be able to provide you specific advice.


Why use Newcells in vitro kidney models?

In vitro assays such as our podocyte and proximal tubules models are well-qualified near physiological models of tissues that provide robust, reproducible data from which informed decisions can be made either about the value of in vivo studies in animals or to provide an understanding of unexpected liability at first in man. Furthermore, our models give a full picture of nephrotoxicity as we have a glomerulus and a proximal tubule model.

Can I purchase your kidney models?

Our fresh proximal tubule model is available for shipment in some regions, but you can also outsource the work to us. Our glomerulus model is currently only available as part of a service.

Can I outsource a kidney in vitro study to you?

Yes, you can, we will design the study with you and can provide you with either a data summary or a full report.

Can I compare different species in vitro?

Yes, this is one of the major advantages of our model, we generate proximal tubule cells from mouse, rat, dog, human and even non-human primate. This allows accurate prediction in humans.

How predictive are your kidney models?

They are very predictive. For example, Takeda has done a study showing the high level of predictivity of our PTC model (Bajaj et al., 2020)

How do you ship your proximal tubule model?

The cells are kept in a stasis media and require revival up receipt. They are shipped at 4 °C.

What are the advantages of your proximal tubule model?

  • Our fresh primary model is extremely well differentiated and representative of in vivo proximal tubule
  • Our flagship model, aProximate™ is supported by a large package of validation data to support its use in transporter and nephrotoxicity assays and its value in predicting in vivo outcome. It is available across the main preclinical species (rat, dog, NHP and mouse) together with human to allow comparative studies.
  • It has been used in regulatory submissions to support NDA and IND submissions
  • If you choose to outsource to us, the service is performed in state of the art laboratories by experienced scientists working to strict SOPs and a Quality Management System.

How are the Proximal tubule cells arranged in the model?

The proximal tubules are arranged as a monolayer and express high levels of transporters than any other in vitro PTC model.

What are the applications of the aProximate™ proximal tubule model?

The model can be used for many applications:

  • Identification of transporter-mediated renal drug clearance pathways for xenobiotics during drug development
  • Identification of clinically important transporter-mediated Drug-Drug interactions during drug development and post market in clinic (drug induced AKI)
  • Identification of cross species differences in renal drug handling – de-risking adverse outcomes at first in man
  • Application of renal model to identify renal target and target engagement/efficacy
  • Development of screening regime for biologics transport and toxicity
  • Identification of drug induced kidney damage using clinically relevant biomarkers of nephrotoxicity, cross species, as a predictive tool to improve ‘first in man’ outcomes

What does a typical transporter experiment in PTCs look like?

  • Proximal tubule cells are plated on 24 well Transwell plates
  • Parallel assays are available using PTCs from a range of species: Human, Dog, Rat, Mouse and Non-Human Primate
  • Cell monolayers undergo QC (TEER of >60 ohms.cm2)
  • We measure Absorptive flux (apical to basolateral; Jab), Secretory Flux (basolateral to apical; Jba) and calculate Net flux (Jnet= Jba-Jab)
  • We can measure transport of either small molecules or large molecules in our system
  • We can measure radiolabelled compounds using scintillation counting or non- labelled compounds by LC-MS
  • We correct for paracellular flux using either radiolabelled Mannitol or unlabelled Lucifer Yellow
  • We include a positive control (usually 3H-PAH or 14C-creatinine) as a QC of assay performance
  • To understand mechanisms of transport or Drug-Drug interactions, we can run experiments in the presence of specific inhibitors of transport proteins.
  • We provide either the raw data or a full package of transcribed and analysed data, data summary and a report

What does a typical Nephrotoxicity experiment look like in PTCs?

  • Proximal tubule cells are plated on 96 well Transwell plates
  • Parallel assays are available using PTC from a range of species: Human, Dog, Rat, Mouse and Non-Human Primate
  • Cell monolayers undergo QC (TEER of >60 ohms.cm2)
  • Cells can be challenged for 24, 48, 72 or 96 hours with compounds under investigation
  • We measure 6 endpoints of kidney injury: KIM-1, NGAL, Clusterin, TEER, Cellular ATP content, LDH release

What does the podocyte model look like, and it is functional?

Our podocyte model is composed of a monolayer of freshly isolated and fully differentiated podocytes. The podocyte model recapitulates the structure and function of the glomerular filtration barrier showing size and charge selectivity which can be modulated by the addition of known nephrotoxic drugs affecting the glomerular filtration barrier such as puromycin and adriamycin.

What are the advantages of your glomerulus podocyte model?

The model is one of the first robust, fully differentiated, fresh primary podocyte model for in vitro assessment of drug-induced renal toxicity in the glomerulus.

What are the applications of the Glomerulus model?

Our unique service evaluates podocyte injury and glomerular permeability in vitro and allows our clients to assess the effect of their compounds on the glomerulus.

What does a typical glomerular toxicity experiment look like?

  • Podocytes cells are plated on 96 well Transwells
  • Cell monolayers undergo QC (TEER of >60 ohms.cm2)
  • Cells can be challenged for 72 hours with compounds under investigation
  • We measure 3 endpoints of podocyte injury: TEER, Cellular ATP content, and permeability of 70 kDa FITC-dextran

Have you any experience of working with large molecules or biologics?

Yes, we have extensive experience of working with both small and large molecules. aProximate™ proximal tubule cells express both Megalin and Cubulin and the transferrin receptor.  We have extensive experience of measuring both transepithelial transport, cellular accumulation and potential nephrotoxicity of a wide range of large molecules including;  siRNA, Anti-sense Oligonucleotides, peptides, antibody fragments, antibiotics and other large drug molecules.

How much material do I need to send for a study?

The amount of material depends on the size of the study, the molecular weight of the compound and the concentration range tested.  We can provide that information as we generate a scope of work for the project.

What is the timescale in delivering results?

The turnaround time to deliver experimental results varies depending on the nature and size of the study and which species is required.  As a rough guide:

Transporter study: 3 separate biological kidneys 6-8 weeks
Nephrotoxicity Study PTC and Glomerulus : 3 separate biological kidneys 10-12 weeks

These timescales are estimates for studies involving human, rat, dog or mouse kidney.  NHP kidney is subject to availability.

Do you offer any other assays?

In addition to transporter, DDI and nephrotoxicity assays we also offer:

  • SeaHorse assay of mitochondrial health
  • Generation of samples of Toxigenomic studies
  • Generation of samples for RNA TempO-seq analysis
  • High content screening


How do you simulate the lung fibroblasts?

We use the classical fibrotic agent, TGFβ.

Can I order your primary human lung fibroblasts?

The primary human lung fibroblast model is only available as a service for our FMT assay. The advantage of outsourcing to us is that our experts to design the best experimental protocol.

What does a typical experiment look like?

We usually expose our cells to compounds at a range of concentrations then stimulate FMT transition for 72h and evaluate the ability of the compound to reduce ECM deposition. We recommend performing the experiments with cells from three different donors to validate the results. All  readouts are performed using High Content Imaging (HCI).

How do you measure fibrotic changes?

We evaluate several markers, including α-SMA (alpha smooth muscle actin A), collagen I and collagen III.

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