Horiba announces its participation in a consortium formed to accelerate the development of process analytical technologies (PAT) in cell and gene therapy manufacturing. The company says its A-TEEM molecular fingerprinting technology has shown promise for fast QC/QA of complex biological systems and is being assessed for its capability to reduce batch failures and manufacturing costs.
Headed by the Cell and Gene Therapy Catapult, the consortium comprises technology providers, pharmaceutical companies, therapy developers and charities, and will evaluate the application and combination of technologies from multiple industries to develop PAT specifically for CGT manufacturing.
Horiba’s A-TEEM molecular fingerprinting technology, which powers its Aqualog Industrial QC/QA Analyser, is a “column free” spectroscopic technique that simultaneously measures absorbance, transmittance and a fluorescence excitation emission matrix (A-TEEM). Requiring little or no sample preparation, Horiba claims, A-TEEM is suitable for QA/QC of biopharmaceutical cell media as it can shed light on subtle biochemical changes within bio-reactors. This provides valuable insight into cell health and promotes efficient cell growth processes.
Working within the consortium will allow analysts to couple data from the system with information from other sensors to obtain a scientific overview of the process. Through this model of collaborative work and sharing of data, partners hope to accelerate expertise in this area and gain industry specific knowledge to integrate and combine cell and gene therapy process analytical technologies into their offering.
Dr Simon FitzGerald, Technical Manager at Horiba UK said: “This consortium offers a unique blend of expertise and capability covering technology, pharmaceutics, therapy and patient need. Our continued spirit of addressing new scientific challenges with an ever-evolving suite of core technologies comes together perfectly within this consortium, where the power of A-TEEM molecular fingerprinting will be truly explored and harnessed. Data and knowledge in context are key to progress - this consortium will deliver both, helping to bring advanced therapies to patients more quickly.”
Matthew Durdy, CEO at Cell Gene Therapy Catapult commented: “The industry needs to make a giant leap in terms of analytical capability and the dynamic use of information to control and improve processes, product and costs. The coming together of these leaders in the field is a very important first step towards achieving this.”