Arecor

Advanced delivery of biologics

Arestatâ„¢ technology - In Depth

Arestat™ technology can be applied to a broad range of proteins and peptides

Arecor has significant experience and a proven track record in applying the ArestatTM technology platform to deliver superior biopharmaceutical product profiles across a broad range of proteins and peptides, including:

INSULINS & OTHER DIABETES PEPTIDES

Arecor is leveraging this unique formulation platform to develop a portfolio of proprietary products enabling improved treatments for diabetes care via the innovative reformulation of approved proteins and peptides.

More information can be found under ‘PRODUCTS’

STABLE AQUEOUS PEPTIDES

By 2018 global therapeutic peptide market expected to reach sales >$25 billion, however, improving stability and enabling innovative and convenient routes of administration remains a significant challenge, particularly:

  • Solubility/gel formation
  • Particles/fibrils
  • Hydrolytic cleavage
  • Charge variants

Arecor has an excellent track record in addressing physical stability, including gel and particle formation in addition to unique formulation platforms to address hydrolytic degradation

HIGH CONCENTRATION THERAPEUTIC ANTIBODIES

There is a significant need for innovative formulations to enable high concentration antibodies for subcutaneous injection:

  • Liquid formulations at high concentrations are required due to limited injection volume (typically <2 mL)
  • Increase in concentration leads to viscosity and stability issues, particularly aggregation and particulate formation

Arestat™ technology can deliver stable aqueous highly concentrated formulations of antibodies that would otherwise not be feasible using conventional formulation science.

NOVEL FORMAT PROTEINS

There has been a significant trend towards the development of novel antibody format biopharmaceuticals such as fusions proteins, bi-functional antibodies and antibody-drug conjugates (ADC). These products pose significant formulation and stability challenges which require an innovative formulation approach. Arecor has a proven track record working with major pharmaceutical and biotech companies to develop superior formulations of their novel format proteins.

Novel format products pose significant stability challenges all of which can be addressed with the ArestatTM technology platform:

  • Propensity to aggregate
  • Propensity to hydrolytic degradation
  • Lyophilisation is often the only option to achieve a stable product

BIOSIMILARS

ArestatTM is uniquely placed to deliver differentiation via innovative formulation within current Biosimilar guidance in the form of:

  • Market Penetration & Protection: Developing formulations of biosimilar products with Freedom to Operate within an increasingly crowded space and subsequent formulation IP protection
  • Improved end-user convenience: Such as conversion of lyophilised formulations to stable aqueous formulations to remove the need to reconstitute by the end user
  • Enhanced stability: Removal of cold-chain requirement for some or all of product shelf-life and in-use period
  • Life Cycle Management for competitive advantage: Such as enabling stable aqueous high concentration mAbs to allow more convenient administration (Note: A change in route of administration requires a full review of the development and regulatory implications in relation to the current biosimilar guidance for each intended launch territory)