Preclinical Research

The clinical trial process can be lengthy, expensive and challenging. That’s why, before you embark upon it, a well conceived and directed preclinical program is a must. At GreenLight Clinical, the tailored programs from our experienced team of researchers give you the best opportunity to critically evaluate the clinical potential of your prospective therapeutic. 

 

GreenLight Clinical’s contract research service is committed to providing reliable, innovative and translatable preclinical models and services that advance drug discovery and support the development of identified clinical candidates. We aim to work strategically with our clients to develop efficient preclinical research programs that both contribute to regulatory requirements and which meet business objectives.

 

Preclinical Services & Technologies

In addition to our in-house expertise, GreenLight Clinical has a number of collaborative relationships with academic laboratories that allow us to offer a wide range of analyses and models. From full toxicology and pharmacokinetic evaluations to safety/tolerability and efficacy studies, we can fully profile candidate therapeutics and medical devices.

With access to a suite of in vitro assays, cell lines and biomarker technologies, together with a range of both well-established and proprietary animal models for many therapeutic areas, GreenLight Clinical can offer an efficient and comprehensive preclinical service. And as with all our other services, we ensure a rapid turnaround time, with reliable data generation and reporting that supports timely business decision-making.

 

 In Vivo Animal Models of Disease

 Oxygen Induced Retinopathy (OIR):

Models of oxygen-induced retinopathy (OIR) have played a pivotal role in our understanding of retinal development and in the testing of novel therapeutics such as anti-VEGF therapies for age-related macular degeneration. The models are cost-effective, reproducible and offer an excellent entry point to test novel anti-angiogenic therapies for diseases such as AMD, diabetic retinopathy and retinopathy of prematurity. Our team are experts in the application of these models, with over 25 years experience in the field, and numerous high-impact publications using these models.

GreenLight Clinical offers OIR models in both the mouse and rat:

Models available:

75% model of mouse OIR

50/10 model of rat OIR

 

Laser-induced choroidal neovascularisation (CNV)

Laser-induced choroidal neovascularisation offers a cost-effective model of wet age-related macular degeneration (AMD), reproducing the hallmark event of the disease – rupture of Bruch’s membrane and subsequent uncontrolled pathological blood vessel growth in the choroid. Mouse and rat models of CNV have been utilised in the testing of numerous treatments of wet AMD, and have been pivotal to our understanding of this debilitating disease.

GreenLight Clinical offers clients models of laser-induced choroidal neovascularisation in both mice and rats, with expert knowledge available from our collaborating laboratories and clinician-scientists to help you better understand the effects of your therapeutics.

Models available:

Laser-induced CNV in mouse and rat

 

Diabetes and Diabetic Retinopathy

The disease burden from diabetes, and diabetes-related complications, is on the rise. GreenLight Clinical offers models that replicate the features of both Type 1 (insulin-dependent) and Type 2 diabetes. Our researchers have published numerous high-impact papers using these models, and our clinical team has over 30 years experience in interpreting and treating the ocular complications of diabetes.

Models available:

STZ-induced Type 1 diabetes in rat & mouse

STZ and high-fat diet Type-2 diabetes model in rat & mouse

 

 In Vitro Experimental Models

In collaboration with our partner research laboratories, GreenLight Clinical can provide sponsors with numerous in vitro experimental models for safety and efficacy profiling of your products to the highest standard. Using unique primary cell lines from human and animal sources, along with well-established immortalised cell lines and state-of-the art assays, GreenLight Clinical can get your product from bench to bedside faster.

 

Cell-lines available:

Human foetal cortical-derived human neural precursor cells and astrocytes

In conjunction with our partner research laboratories, GreenLight Clinical has access to a unique bank of human foetal cortical-derived neural precursor cells and astrocytes. These cells can give sponsors unique insights into the direct effects of products on the cells of the human central nervous system. With over 20 years experience in the isolation, characterisation and study of these cells, GreenLight Clinical offers a unique test-bed, unavailable to the majority of other CROs.

 

Glioblastoma Multiforme

Gliblastoma Multiforme is the most aggressive cancer of the brain, with severe impacts on quality of life and a significant economic cost to sufferers and their families. With access to primary human glioblastoma cell lines, with full case histories, GreenLight Clinical offers sponsors unique insight into the effectiveness of their products in treating this insidious disease.  As the human central nervous system is unique, our approach to testing products in both human and animal cell lines help can get your product to market faster, and enables sponsors to see the effect of their product at a cell-by-cell level, using electron microscopy and state-of-the-art molecular biology techniques.

 

Retinal Pigment Epithelium Cell Lines

The retinal pigment epithelium (RPE) helps to maintain normal vision by creating a barrier between the mostly avascular retina, and the highly vascularised choroid and nourishing the neural cells of the retina. Pathological and age-related changes to the RPE can have significant effects on disease progression.

However, the majority of work conducted on the RPE in vitro is conducted in the ARPE-11 cell line. While an effective and useful surrogate for the RPE in vivo, it the ARPE-11 cell line does not take into account the effect of physiological aging on human RPE.

GreenLight Clinical has an extensive suite of primary human RPE cell lines sourced from young adults, all the way through to aged (80+ year old) cells, that can give sponsors insight into the effectiveness of their solutions in the target demographics which they are aimed at. With the overwhelming burden of AMD concentrated in the elderly, our unique RPE cell lines can offer sponsors unparalleled feedback on the relationship between their products and the RPE.

 

 

Laboratory Assays, Microscopy, Histology and Molecular Biology

  • Histopathology – paraffin sections (H&E, Milligan’s Trichrome, Toluidine Blue)
  • Cryostat sections followed by single or multi-marker immunofluorescence utilising lineage-specific markers for astrocytes, neurons, oligodendrocytes, vascular endothelial cells, pericytes, smooth muscle cells, lymphatics, angiogenic markers
  • Confocal Microscopy
  • Deconvolution Microscopy
  • High-throughput automated slide scanning
  • Transmission Electron Microscopy
  • Muse Cell Analysis – for in vitro quantification of cell viability, apoptosis, cell cycle, proliferation, mitochondrial membrane potential in all cell lines.
  • Guava Flow cytometric analysis – for heat shock protein and heat shock factor-1 expression.
  • Cell Migration Assays via Incucyte
  • Seahorse XF Bio-Energetics Analysis