Industrial pipeline

Bridge to industry – intro text

The Manchester Regenerative Medicine Network aspires to act as a conduit through which clinicians and basic researchers are able make contact with SME’s providing cell therapy products and biomaterials, which will expedite the translation of research to viable therapies.

Bridge to industry – companies

Below is a listing of SME’s within the Greater Manchester area which are involved in Regenerative Medicine or are outside of Greater Manchester, and provide a service not available within Manchester; for example the production of cGMP viral vectors.

Rayne Cell Therapy Suite (RCTS)

Rayne Cell Therapy Suite (RCTS)is a GMP production facility located on the Denmark Hill Campus, University College London, and has been in operation since 2001. RCTS is licenced by the Human Tissue Authority (HTA) for the procurement, storage, human use, import and export of cell therapy based products. RCTS is licenced by the Medicines and Healthcare products Regulatory Agency (MHRA) with Manufacturing Authorisation (MA) for the production of cell, gene therapy and regenerative medicine based Investigational Medicinal Products (IMP). RCTS also holds a separate “Specials Licence” (MS) for the production of cell and gene therapy products for their off-trial clinical use. Both the MS and MA IMP licences have import and export permits.

The RCTS is useful to the Manchester Regenerative Medicine Community as it can produce cGMP gene therapy vectors.

Cellular Therapeutics Ltd (CTL)

CTLs strategy is to develop the technology of cellular therapy manufacturing so it can be applied on a routine basis to large numbers of patients. Using clean room free technology developed specifically for the processes of cell therapy, Cellular Therapeutics has the capability to produce individualised cell therapy products in a cost effective and high throughput manner.

The CTL is useful to the Manchester Regenerative Medicine Community as it is licensed to traduce cells with gene therapy vectors under cGMP conditions.

PeptiGelDesign

PeptiGelDesign develops novel medical therapies for accelerating damaged tissue healing and regeneration across a range of medical applications. The company develops and manufactures niche specific biodegradable peptide gels and cardiac patches designed to restore a normal heart muscle contractile function by providing a structural reinforcement to infarcted myocardium.

PeptiGelDesign is useful to the Manchester Regenerative Medicine Community as it can provide defined three-dimensional hydrogel scaffolds for cell culture applications.

Stratastem

StrataStem spun out from the University of Manchester in 2015 and is led by Dr’s Lisa Mohamet and Chris Ward. Their proprietary technology enables human pluripotent stem cells from both healthy and disease affected individuals to be differentiated into neural stem cells of high purity (>95% guaranteed) and subsequently matured into astrocytes, neurons and oligodendrocytes. Utilising our novel technology, neural stem cells/progenitors are generated in half the time of current practices and the use of unique small peptide inhibitors, improves consistency over current methodologies employing the use of growth factors which have considerable batch variation. StrataStem have also recently developed a number of highly accurate and sensitive assays to detect early changes in neuronal pathology, allowing us to explore Alzheimer’s disease modelling and future personalised medicine applications. StrataStem’s patented technologies have been developed to provide researchers with a new tool to study human neurological diseases in regenerative medicine applications and all enquiries are welcome.

Epistem

Epistem was established on the basis of several decades of ground-breaking research by founders Prof. Chris Potten and Dr Catherine Booth, identifying and characterising the location and behaviour of epithelial stem cells with a particular focus on the small intestine. Epistem is therefore in a unique position, utilising this scientific heritage and expertise, to identify key regulators of epithelial stem cell regulators and develop novel therapeutics targeting this mechanism.

Gelexir Healthcare

Gelexir Healthcare Ltd, Manchester, UK, is introducing a novel, non-surgical procedure for the treatment of Chronic Lower Back Pain (CLBP) caused by Degenerative Disc Disease (DDD), at an early stage before the onset of irreversible disc degeneration of both the nucleus pulposus and annulus fibrosis material.  Gelexir’s approach centres on a pH responsive Double Cross Link hydrogel (DXM) designed to collaborate with the native nucleus pulposus . The DXM, thanks to its hydrophilic properties, works as an alternative to the degraded proteoglycan matrix, the protein mesh surrounding the cells, and therefore compensates the consequences of the degradation and slows down the progression of the degeneration of the nucleus pulposus.

Bridge to industry – companies

Below is a listing of SME’s within the Greater Manchester area which are involved in Regenerative Medicine or are outside of Greater Manchester, and provide a service not available within Manchester; for example the production of cGMP viral vectors.

Rayne Cell Therapy Suite (RCTS)

Rayne Cell Therapy Suite (RCTS)is a GMP production facility located on the Denmark Hill Campus, University College London, and has been in operation since 2001. RCTS is licenced by the Human Tissue Authority (HTA) for the procurement, storage, human use, import and export of cell therapy based products. RCTS is licenced by the Medicines and Healthcare products Regulatory Agency (MHRA) with Manufacturing Authorisation (MA) for the production of cell, gene therapy and regenerative medicine based Investigational Medicinal Products (IMP). RCTS also holds a separate “Specials Licence” (MS) for the production of cell and gene therapy products for their off-trial clinical use. Both the MS and MA IMP licences have import and export permits.

The RCTS is useful to the Manchester Regenerative Medicine Community as it can produce cGMP gene therapy vectors.

Cellular Therapeutics Ltd (CTL)

CTLs strategy is to develop the technology of cellular therapy manufacturing so it can be applied on a routine basis to large numbers of patients. Using clean room free technology developed specifically for the processes of cell therapy, Cellular Therapeutics has the capability to produce individualised cell therapy products in a cost effective and high throughput manner.

The CTL is useful to the Manchester Regenerative Medicine Community as it is licensed to traduce cells with gene therapy vectors under cGMP conditions.

PeptiGelDesign

PeptiGelDesign develops novel medical therapies for accelerating damaged tissue healing and regeneration across a range of medical applications. The company develops and manufactures niche specific biodegradable peptide gels and cardiac patches designed to restore a normal heart muscle contractile function by providing a structural reinforcement to infarcted myocardium.

PeptiGelDesign is useful to the Manchester Regenerative Medicine Community as it can provide defined three-dimensional hydrogel scaffolds for cell culture applications.

Stratastem

StrataStem spun out from the University of Manchester in 2015 and is led by Dr’s Lisa Mohamet and Chris Ward. Their proprietary technology enables human pluripotent stem cells from both healthy and disease affected individuals to be differentiated into neural stem cells of high purity (>95% guaranteed) and subsequently matured into astrocytes, neurons and oligodendrocytes. Utilising our novel technology, neural stem cells/progenitors are generated in half the time of current practices and the use of unique small peptide inhibitors, improves consistency over current methodologies employing the use of growth factors which have considerable batch variation. StrataStem have also recently developed a number of highly accurate and sensitive assays to detect early changes in neuronal pathology, allowing us to explore Alzheimer’s disease modelling and future personalised medicine applications. StrataStem’s patented technologies have been developed to provide researchers with a new tool to study human neurological diseases in regenerative medicine applications and all enquiries are welcome.

Epistem

Epistem was established on the basis of several decades of ground-breaking research by founders Prof. Chris Potten and Dr Catherine Booth, identifying and characterising the location and behaviour of epithelial stem cells with a particular focus on the small intestine. Epistem is therefore in a unique position, utilising this scientific heritage and expertise, to identify key regulators of epithelial stem cell regulators and develop novel therapeutics targeting this mechanism.

Gelexir Healthcare

Gelexir Healthcare Ltd, Manchester, UK, is introducing a novel, non-surgical procedure for the treatment of Chronic Lower Back Pain (CLBP) caused by Degenerative Disc Disease (DDD), at an early stage before the onset of irreversible disc degeneration of both the nucleus pulposus and annulus fibrosis material.  Gelexir’s approach centres on a pH responsive Double Cross Link hydrogel (DXM) designed to collaborate with the native nucleus pulposus . The DXM, thanks to its hydrophilic properties, works as an alternative to the degraded proteoglycan matrix, the protein mesh surrounding the cells, and therefore compensates the consequences of the degradation and slows down the progression of the degeneration of the nucleus pulposus.

Bridge to industry – regulatory information

Regulatory information

MHRA Innovation Office

Cell Therapy Regulatory Toolkit