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UK: Process Analytical Technologies Cell and Gene Therapy: Consortium Plans to Accelerate Technology Development

Editor: MA Alexander Stark

A consortium wants to assess multiple new or existing process analytical technologies (PAT), including Horiba’s A-TEEM fluorescence technology. The aim is to accelerate technology development and potentially lower cost in cell and gene therapy manufacturing.

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Horiba’s Aqualog analyser powered by A-TEEM Molecular Fingerprinting technology used in PAT
Horiba’s Aqualog analyser powered by A-TEEM Molecular Fingerprinting technology used in PAT
(Source: Horiba)

Northampton/UK — Horiba has joined a consortium of over 20 organisations, formed to accelerate the development of process analytical technologies (PAT) in cell and gene therapy manufacturing. The company’s new A-TEEM Molecular Fingerprinting technology is a core technology being assessed for reducing batch failures and manufacturing costs, to enable faster time to market.

Headed by the Cell and Gene Therapy Catapult, the consortium is the first of this scale, with functional expertise and mission within the cell and gene therapy space. Comprising technology providers, pharmaceutical companies, therapy developers and charities, it will evaluate the application and combination of new and existing technologies from multiple industries to develop PAT specifically for cell and gene therapy (CGT) manufacturing.

The company's patented new A-TEEM Molecular Fingerprinting technology, which powers their Aqualog Industrial QC/QA Analyser, is simple, fast, and cheap “column free” spectroscopic technique that simultaneously measures Absorbance, Transmittance and a fluorescence Excitation Emission Matrix (A-TEEM). Requiring little or no sample preparation, 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 ensures the most efficient cell growth processes.

Working within the consortium is to allow analysts to couple data from the Horiba system with information from many other sensors to obtain a broad scientific overview of the process. Through this model of collaborative work and sharing of data, partners will accelerate their expertise in this area and gain industry specific knowledge to integrate and combine cell and gene therapy process analytical technologies into their offering.

The new PAT consortium will act as a catalyst in fast-tracking knowledge and understanding at reduced cost and investment risk to each organisation. Access to this key information will allow technology providers and manufacturers to develop lower cost and more robust manufacturing processes, accelerating development of advanced therapeutics.

The organisations that have formed the process analytics consortium are: Aber Instruments; Anthony Nolan; BD; Bio-Techne; Cambridge Consultants; Cell and Gene Therapy Catapult; Chemo Metec; C-CIT Sensors; Cytiva; Eppendorf; Glaxo Smith Kline (GSK); Horiba; Imspex Diagnostics; Kaiser Optical Systems, an Endress+Hauser company; Lonza; Ocean Insight; Ori Biotech; Oxford Nanoimaging; Quantex; See-Through; Telo Nostix; Terumo Blood and Cell Technologies; Univercells Technologies.