AI Magazine Issue 2 2018- Global Care Clinical Trials

12 Acquisition International - Issue 2 2018 PharmaFluidics is a young, dynamic and fast paced technology company based in Ghent, Belgium. CEO, Mr Johan Devenyns gives us an insight into the solutions and impressive technology provided by the firm. he future of Bio-Analysis with micro- Chip chromatography PharmaFluidics develops and commercialises its unique µ PAC TM range of micro-Chip based chromatography columns for use in biomarker, diagnostics and drug research & development applications in the global biotech and pharma industries. The unique approach of smart design and lithographically defined microfabrication of PharmaFluidics’ µ PAC TM separation beds, leads to game-changing reproducibility, separation performance and sensitivity allowing analysts and researchers to identify substantially more compounds in complex biological samples, such as biopsies, proteome digests, culture media or bio- pharmaceutical actives. Interestingly, the key expertise and IP estate of PharmaFluidics are the design, lithographic production, and surface treatment of silicon wafers for use as separation devices in liquid chromatography. PharmaFluidics collaborates with an extensive network of centres of excellence, pioneer users and global Mass Spectrometry instrument providers to develop an increasing range of applications. PharmaFluidics’ unique technology platform and product range; the µ PAC TM column series, offers unprecedented robustness and reproducibility as well as state-of-the-art sensitivity and resolution performance. The first clients, academic labs in bio-analysis, bio-pharmaceuticals and diagnostics companies, have confirmed these outstanding characteristics of the µ PAC TM technology. µPAC TM makes its marks in the market In September 2017, the company started shipping µ PAC TM columns and has since served proteomics laboratories, medical centres and pharmaceutical companies on three continents: Europe, the USA and Asia. Its pioneering product is very well received, and has convinced pioneer users and key opinion leaders in proteomics to use micro-Chip based chromatography. New funds to boost growth PharmaFluidics successfully concluded a capital increase in the amount of € 7,3m from existing and new shareholders. The funds will be used to further develop the Pillar Array technology platform, to expand the µ PAC TM product range, and to scale up production and global sales. “This funding will significantly boost our capacity to support our Company: PharmaFluidics Contact: Mr Johan Devenyns Email: [email protected] Address: Technologiepark- Zwijnaarde 3, Gent, B-9052, Belgium Phone: 0032 9 241 56 57 Web Address: www.pharmafluidics.com A Game Changer in Technology T 1802AI10 growth,” said PharmaFluidics’ Managing Director Johan Devenyns. A new approach for Sample Limited bio-analysis applications Importantly, the past few years have seen the introduction of advanced bio-analytical technologies such as Next Generation Sequencing (NGS) and Liquid Chromatography/Mass Spectrometry (LC/ MS); together they provide unprecedented power for integrated and systematic investigation of, respectively, cellular genomes, transcriptomes, and their proteomes and metabolomes. Essentially, the holy grail of proteomics and metabolomics is to decode the proteome and the metabolome at the single cell level. This imposes enormous challenges to sensitivity, as there are no amplification methods for proteins and metabolites comparable to those of nucleic acids. Although the current packed bed nano-LC/MS is generally considered a sensitive approach, it can be associated with limited chromatographic performance, poor column reproducibility and fluidic handling problems; hence single cell proteomics has yet to be achieved. Crucial to its success, the unique performance of the µ PAC TM columns brings ground-breaking applications within reach. For example, the robustness and reproducibility allow proteomics data from different labs to be pooled, making reliable big data analysis possible. The miniaturisation, robustness and sensitivity open the door to point-of- care nano-LC-MS. An innovative LC-MS approach for characterisation of bio-pharmaceuticals For over 100 currently marketed bio-pharmaceutical reference products, there is a pipeline with nearly 800 bio-similars and about 500 bio-betters in development. Proving bio-equivalence and monitoring batch-to-batch variation are forcing the regulatory landscape to change. Increasing bio- therapeutic complexity, including anti-body drug conjugates, is forcing new methodologies. The drive towards continuous bio-manufacturing requires new and more on-line production analysis, and high- resolution, robust workflows are required. These developments are providing tremendous opportunity for new bio-analytical techniques. Recently, PharmaFluidics’ micro-Chip chromatography device has been used to characterisemonoclonal antibodies. The combination

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