Expertise

 Our expertise spans academic, clinical, and commercial development to present a comprehensive portfolio of solutions to our clients.

Cellular differentiation and biology

We offer advice on the design of culture systems and technologies. We pay particular attention to end-product quality and purity, cost-of-goods, scaling up solutions, manufacturing processes, and clinical grade applications. 

  • Cellular therapies are emerging as the next breakthrough in medical science in great part due to the use of expandable stem cell sources such as pluripotent stem cells and accurate genome editing that enables the creation of cellular products with enhanced clinical benefit.

    The major challenges of these technologies to reach the clinic and commercial exploitation are scaling up, cost-of-goods and regulatory concerns.

    We offer comprehensive advice from the basic science at the academic stage of development to the translation to the clinic. We have expertise in a wide range of culture systems and cell types particularly those derived from pluripotent stem cells. We offer advice on genome editing pipelines and quality assessment post-editing. We have in-depth knowledge of systems that allow controlled gene expression and to maximise cellular maturation and potency. We can also advice on the use of adequate in vivo models to assess issues of clinical efficacy and safety.

    We offer solutions in the early stage of development that facilitate subsequent scaling up, reduce cost-of-goods and enable transition to clinical grade manufacturing. By identifying potential regulatory issues early we streamline the transition to human clinical trials.

Clinical trials

We offer advice on design of human trials (including early phase trials), development of laboratory and clinical protocols, portfolio of laboratory analyses particularly applied to safety and regulatory requirements.

  • Setting up clinical trials with cellular therapies is a major challenge. We offer advice on the most appropriate trial design to answer the specific question at hand. This ranges from early stages micro-dosing and tracing studies to establishing proof of principle and safety to Phase II trials to establish clinical benefit with dose escalation and randomisation options.

    We have expertise in developing clinical protocols and applications to ethical committees and regulatory agencies. This includes the portfolio of preclinical studies in vitro and in vivo to establish potency and safety as well as power calculations. We offer advice on recruitment and clinical management of trial participants.

    We have in-depth knowledge of in-line culture monitoring, formulation of the final products, storage and stability, release criteria and aspects of product distribution, including in-transit temperature control and monitoring.

Blood cells and transfusion

We offer advice on a range of issues that may arise in the formulating, distribution and administration of blood cell therapies and transfusion products in both a research context and blood banking and hospital transfusion management.

  • Blood cell therapies and non-cellular blood products have been used in clinical practise for decades. The issue of blood-derived product safety has been at the forefront of research and clinical practice particularly following the emergence of HIV and hepatitis viruses. We offer advice on novel technologies that are emerging to provide additional safety features to donor-derived products.

    The recent pandemic as well as the more frequent extreme climate events have brought in sharp relief the importance of stock management and building resilience in the provision of blood products to the front line. We offer advice on solutions to enhance resilience to blood shortages, including novel solutions to prolong blood product storage and decrease the risk of bacterial contamination.

    Successful transfusion of blood products is a decades-long discipline of medicine and, as a consequence, one where true evidence-based practise can be lacking. As new blood products emerge in the context of pathogen reduction or a bid for universality, clinical trials are now more necessary than ever. We offer advice on how to approach these clinical trials, from small scale proof-of-principle recovery and survival studies to large, multicentre randomised trials.