OREANDA-NEWS. Glythera Limited, the next generation Antibody Drug Conjugate (ADC) company, today announces  that, through a consortium with GlycoSeLect Ltd, specialists in the development and production of recombinant prokaryotic lectins and the Biologics unit of the Centre for Process Innovation (CPI), a UK-based technology innovation centre and part of the High Value Manufacturing Catapult, they have been awarded £248,000 by Innovate UK, the UK government's innovation agency, to develop a high-throughput glycosylation assay to facilitate the development of next generation biological therapeutics.

The Early Stage Feasibility Study award will support the development of a novel, rapid and high-throughput Lectin based analytical methodology that will be used to further streamline drug development pathways using Glythera's PermaCarb™ technology platform.

Glythera has previously demonstrated that direct substitution of naturally occurring glycans with its PermaCarb™ platform has the potential to improve drug bioavailability whilst also correcting potentially immunogenic non-human glycosylation profiles. This approach has broad applications in drug discovery, development and production, especially in the high-value biobetter & biosimilar markets.

The project aims to demonstrate the feasibility of using novel, selective recombinant prokaryotic lectins (RPLs) to develop a companion assay to monitor and characterise specific biotherapeutic glycosylation profiles in a high throughput, low cost manner. GlycoSeLect has previously developed a series of glycan selective RPLs and demonstrated applicability for the characterisation, purification and manufacturing of biotherapeutics.  Transition to a rapid analytical methodology will add further intensification to Glythera's existing manufacturing processes, allowing rapid characterisation of drug intermediates as well as the final product.

Integrating two novel and powerful technology platforms to provide a complete solution for biotherapeutic glycosylation correction and characterisation has significant potential to accelerate the development of commercially viable drug pipelines, particularly in the growing ADC and biobetter markets.

Dr Dave Simpson, CEO of Glythera, said:

"The funding from Innovate UK will further enhance Glythera's established PermaCarb™ drug development technology through the expansion of GlycoSelect's analytical platform and fundamentally remove the analytical bottlenecks typically associated with development and manufacture of complex biotherapeutics. This combined technology offering will allow Glythera to drive the industry's ability to develop novel drugs from multiple product classes which can be administered at lower doses and / or reduced frequency. This is an important step in the advancement of next generation biological medicines and could lead to improved patient responses."

Robert Dunne, CEO of GlycoSeLect, said:

"GLycoSeLect is excited about this collaboration with two important partners which will help to further validate our RPL technology as a first pass, efficient and cost-effective analytical tool for the characterisation of biotherapeutics. This programme will help to demonstrate that our RPLs offer a rapid, orthogonal approach to drug characterisation for this important and growing drug class".

Dr Chris Dowle, Director of Biologics at CPI, said:

"CPI is very pleased to be a partner in this project and helping two SMEs to develop their business and achieve success. The project is in line with our Biologics strategy to support the commercialisation of new process and analytical technologies for current and next generation biologics"

Glythera Limited

Glythera specialises in the development of next generation biotherapeutics, through the application of its advanced proprietary linker and stable glycan technologies: PermaLink™ and PermaCarb™.    Our linker technology platforms have the potential to enhance and strengthen pharmaceutical drug candidates.

Biotherapeutics are an integral part of modern medicine, particularly in the oncology space, due to their efficacious properties and ability to target specific molecules within the human body.  The Antibody Drug Conjugate (ADC) field is a key area within the protein and antibody engineering industry.  ADCs are complex molecules composed of an antibody linked to a biological active cytotoxic (anti-cancer) drug.  A stable link between the antibody and cytotoxic agent is a crucial aspect of an ADC.  Glythera's highly specific, stable linker technology addresses many of the instability issues faced by current conjugation methods.  Our technology platforms enable efficient and cost effective development and manufacture of new efficacious biologics that improve half-life and optimize bio-availability and which are highly specific, stable, robust and safe.

Glythera's PermaLink™ technology is a controlled, stable conjugation platform composed of a portfolio of linker designs.  PermaLink™ can be employed for the selective and stable functionalization and conjugation of various cargos to proteins and peptides.

PermaCarb™ is a highly stable sialic acid derivative which can be conjugated to a glycan of choice via an enzyme mediated reaction during downstream processing in a scalable and compliant fashion.  Our stable glycan technology PermaCarb™ is designed to facilitate the creation of biotherapeutics which can be administered at lower doses and/or reduced frequency.

About GlycoSeLect Ltd

GlycoSeLect Ltd is an early-stage BioTechnology company developing proprietary next-generation, highly specific and cost-efficient tools for the analysis, characterisation and purification of biotherapeutics. Spun-out from Dublin City University in 2013, GlycoSeLect specialises in the development of RPLs; enhanced glycoselective bioaffinity proteins that enable efficient detection, analysis and selective isolation of glycosylated biomolecules. GlycoSeLect's current family of RPLs target a range of galactose and mannose glycoprofiles and are associated with market leading properties, including high affinity for glycan targets, high sensitivity of detection, high stability and robustness. 

GlycoSeLect UK Ltd was established in 2015 to support further development, provide wider geographic reach and drive commercialisation.

About Centre for Process Innovation

The Centre for Process Innovation is a UK-based technology innovation centre and part of the High Value Manufacturing Catapult. We use applied knowledge in science and engineering combined with state of the art development facilities to enable our clients to develop, prove, prototype and scale up the next generation of products and processes.

Our open innovation model enables clients to develop products and prove processes with minimal risk. We provide assets and expertise so our customers can demonstrate the process before investing substantial amounts of money in capital equipment and training. New products and processes can be shown to be feasible; on paper, in the lab and in the plant before being manufactured at an industrial scale.

By utilising our proven assets and expertise companies can take their products and processes to market faster. There is no down time in production as all of the process development is completed offsite and our technology transfer and engineering teams can help companies to transfer the product or process into full scale production at speed.