The consortium will assess multiple new or existing process analytical technologies (PAT), including HORIBA’s A-TEEM™ fluorescence technology

HORIBA Scientific is proud to announce that it is participating in a new consortium formed to accelerate the development of process analytical technologies (PAT) in cell and gene therapy manufacturing. HORIBA’s new A-TEEM™ Molecular Fingerprinting technology has shown great promise for fast QC/QA of complex biological systems and 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, 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.

HORIBA’s patented new A-TEEM Molecular Fingerprinting technology, which powers HORIBA’s Aqualog Industrial QC/QA Analyzer, is a simpler, faster, and cheaper “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 ideal 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 will 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 organization. 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.

Dr Simon FitzGerald, Technical Manager at HORIBA UK Limited 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, Chief Executive Officer 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.”

The organizations that have formed the process analytics consortium include: ABER Instruments; Anthony Nolan; BD; Bio-Techne; Cambridge Consultants; Cell and Gene Therapy Catapult; ChemoMetec; C-CIT Sensors; Cytiva; Eppendorf; GlaxoSmithKline (GSK); HORIBA; IMSPEX Diagnostics Ltd; Kaiser Optical Systems, an Endress+Hauser company; Lonza; Ocean Insight; Ori Biotech; Oxford Nanoimaging; Quantex; See-Through; TeloNostiX; Terumo Blood and Cell Technologies; Univercells Technologies.

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