Arecor Ltd

Cambridge, United Kingdom

Arecor Ltd

Cambridge, United Kingdom
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An aqueous composition having increased protein stability is obtained by: a. determining a pH at which the protein has stability at the desired temperature; b. adding to the composition at least one displacement buffer wherein the displacement buffer has a pK_(a )that is at least 1 unit greater or less than the pH of step (a); and c. adjusting the pH of the composition to the pH of step (a); wherein the aqueous composition does not comprise a conventional buffer at a concentration greater than about 2 mM and wherein the conventional buffer has a pK_(a )that is within 1 unit of the pH of step (a).


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Small Business Research Initiative | Award Amount: 1.05M | Year: 2017

Arecor is a world leader in developing stable formulations of therapeutics, with in-house development programmes aimed at differentiated product concepts in diabetes. Arecor has solid plans for developing those product concepts to Phase I clinical proof-of-concept and subsequent licensing of the assets. One of the product concepts is liquid glucagon, both for emergency use and as a critical component for a bihormonal pump. Arecor has developed prototype liquid formulations of glucagon showing sufficient stability for a viable commercial product. With the critical support from InnovateUK, Arecor is progressing this asset through pre-clinical development by performing further optimisation to ensure compatibility with a selected delivery device, toxicology studies, formal stability studies and validated pharmacokinetic studies. Following this study, Arecor will be ready to move into Phase I human trial. Stable liquid glucagon product will transform the way glucagon is used for emergency treatment of severe hypoglycaemia episodes by removing the need for a complex reconstitution of the currently marketed lyophilised products. In addition, there is a recognised need for liquid glucagon as a critical component of bihormonal pumps that will also be addressed by this product.


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Smart - Proof of Concept | Award Amount: 59.66K | Year: 2015

The aim of the project is to use innovative formulation technology to develop a proof-ofconcept for insulin product with a consistent, ultra-long release profile. Formulations will first be validated with the use of an in vitro model before demonstrating the ultra-long release profile in a relevant animal model. Arecor is a biotherapeutic formulation company with a technology that has the ability to elongate the time action profile of insulin whilst maintaining a product stability profile suitable for commercialisation. The duration of action for currently marketed products is less than 24 hours in at least a third of patients, which increases the risk of severe life-threatening hypoglycaemic episodes. A consistent, elongated release profile will offer reduced hypoglycaemic risk, whilst in turn improving dose flexibility resulting in improved patient compliance, health benefits and savings for the healthcare provider.


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Collaborative Research & Development | Award Amount: 296.64K | Year: 2017

Availability of low cost insulin products, particularly products that can be distributed and used outside the cold chain is critical to developing an effective healthcare system that can deal with the rapidly increasing incidence of diabetes. This project will combine the expertise and technologies of Arecor and Cadila Pharmaceuticals to develop a innovative, low cost basal insulin product that can be distributed and used outside the cold chain. In addition validated technology will be employed to extend the duration of action of insulin glargine with beneficial consequences to the control of hypoglycaemia. The scope of the project will allow formulation development and optimisation, stability testing and pre-clinical development. Following successful completion of the project, the project partners will progress the asset into clinical development and commercialisation. The final product, which will draw on Arecor’s proprietary formulation technologies and Cadila’s excellent track record in therapeutic development and commercialisation, will represent an attractive commercial opportunity as well as having a strong positive impact on the economic development and social welfare in India.


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Collaborative Research & Development | Award Amount: 623.82K | Year: 2014

A growing number of drugs that are being developed to combat infection and disease are protein based biotherapeutics. The supply of these vital biotherapeutics is limited only to areas where there is a sufficient cold-chain i.e. fridges/freezers. Arecor is a biotherapeutic formulation company that has developed technology to stabilise liquid formulations to improve their shelf life. In collaboration with Manchester Universitys Centre of Excellence in Biopharmaceuticals, Arecor will use the TSB formulated product grant to fund the development of the next generation liquid biotherapeutic formulations that are room temperature stable starting with a new room temperature stable formulation of fast acting insulin. These new biotherapeutic formulations can be shipped to any part of the world without the need for cold-chain storage. Unilever, Lilly and PrismTC will all assist in the development of this new technology that will improve healthcare provision to the third world and reduce the environmental burden of cold-chain provision.


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Collaborative Research & Development | Award Amount: 1.56M | Year: 2015

The aim of this project is to provide new formulations that bring about a step change in biopharmaceutical yield and quality by improving product stability through the most protein degradation sensitive/impactful areas of downstream processing (DSP). This is a novel approach to improving process efficiency as currently protein products have comparatively limited stability in the existing default DSP buffers. To develop a new platform of formulations and formulation strategies this collaborative project will bring together the formulation expertise of Arecor with the DSP expertise at Fujifilm Diosynth Biotechnologies (FDB) and The Centre for Process Innovation (CPI). The platform of formulations and the formulations strategies developed can then be applied to reduce production cost of all biologics to pharma and ultimately cost to healthcare providers. These new formulations may also enable the production of biotherapeutics that are currently very difficult/impossible to manufacture.


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Collaborative Research & Development | Award Amount: 665.62K | Year: 2013

Drug formulation has the power to move a product from a hospital setting directly to the home, empowering the patient to control their own treatment. High concentration formulations of antibodies have the potential to shift the burden of outpatient intravenous infusions in the clinic to the use of a ready-to-use autoinjector. Novel chemicals designed at Arecor have the potential to allow such a shift. Arecor has generated proof of concept data showing their ability to dramatically increase the stability of concentrated antibodies. The stability achieved is measured in not months, but years at elevated temperatures. The objective of this project is to examine a wide range of non-clinical toxicology assays of the novel excipients, the effect on further antibody models and to address the problem of viscosity. The aim is to produce a data package for regulatory approval in injectables and facilitate partnerships to allow this technology to reach the market.


Patent
Arecor Ltd | Date: 2016-01-05

The present invention is based on the surprising discovery that the inclusion of an anionic polymer in the adenovirus formulation enhances long-term stability of the vector composition. An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is provided, together with methods of the preparation of a storage stable adenovirus aqueous formulation.


Patent
Arecor Ltd | Date: 2014-03-13

The present invention is based on the surprising discovery that the inclusion of an anionic polymer in the adenovirus formulation enhances long-term stability of the vector composition. An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is provided, together with methods of the preparation of a storage stable adenovirus aqueous formulation.


Patent
Arecor Ltd | Date: 2013-01-30

The present invention provides an aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/mL and an oligomer of ethyleneimine, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range n=2-12.

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