Lonza and Sanquin spouse for commercialisation of MAT reagents

Lonza Gross sales AG, via its Bioscience Department has joined forces with Sanquin Reagents B.V. to allow drug builders and high quality keep an eye on laboratories to take complete benefit of the ability of the Monocyte Activation Check (MAT).

Lonza headquarters, Basel, Switzerland
  • The brand new partnership will facilitate the worldwide get entry to to the sustainable, extremely delicate method for in vitro pyrogen checking out crucial for the security of parenteral prescribed drugs right through building, manufacture and unlock to marketplace
  • Beneath the settlement, Sanquin’s cryopreserved pooled human Peripheral Blood Mononuclear Mobile-based Monocyte Activation Check (MAT) manner can be added to Lonza’s in depth portfolio of pyrogen checking out merchandise
  • Benefits of the MAT assay are maximum distinguished for advanced formulations, reminiscent of human vaccines and biologics, the place different not unusual checking out methodologies used to make sure product protection would possibly show technical boundaries.

Archie Cullen, Vice President, Normal Supervisor Trying out & Informatics Answers at Lonza, stated: “Drug builders and producers are an increasing number of turning to cutting edge new applied sciences that may facilitate correct, dependable detection of pyrogenic contamination of their merchandise to safeguard affected person well being. At Lonza, we’re dedicated to handing over novel answers that may successfully deal with this want. Via increasing our QC checking out portfolio with Sanquin’s state of the art, sustainable MAT kits, we will now supply our consumers with a whole toolkit they are able to depend on to make sure product protection.”

Dr Harry Bos, Managing Director / Leader Government Officer, Sanquin Reagents B.V., added: “Via combining our clinical wisdom and technical experience on MAT package manufacturing and checking out with Lonza’s in depth achieve and revel in with endotoxin checking out and knowledge research, we will be able to carry the advantages of this robust era to a much wider target audience around the pharmaceutical and biotechnology industries, and additional toughen the security of parenteral therapeutics.” 

Lonza Gross sales AG, via its Bioscience Department, and Sanquin Reagents B.V. have entered right into a strategic partnership for the commercialisation of a spread of specialized reagents for pyrogen checking out of parenteral prescribed drugs and clinical gadgets the usage of the MAT. This partnership expands Lonza’s in depth portfolio of endotoxin checking out merchandise and allows drug builders and high quality keep an eye on (QC) laboratories to discover the entire attainable of the high-performing, sustainable MAT strategy to carry protected prescribed drugs to the marketplace.

Opposite to the traditional Rabbit Pyrogen Check (RPT), which fits through measuring temperature adjustments in rabbits following management of a take a look at pattern, the MAT does no longer contain using experimental animals. As such, it allows QC laboratories to agree to stringent animal welfare rules and meet their sustainability targets. Being a extremely delicate in vitro human cell-based assay, the MAT is able to persistently detecting pyrogenic process in even probably the most advanced prescribed drugs, reminiscent of vaccines and cell- and antibody-based biologics, the place use of the RPT is proscribed.

Beneath the brand new settlement between Lonza and Sanquin, cryopreserved pooled human Peripheral Blood Mononuclear Cells (PBMCs) produced through Sanquin particularly to be used with the MAT will undergo the Lonza branding. The cells are advanced consistent with the necessities of the Eu Pharmacopoeia bankruptcy 2.6.30, following an optimised donor variety, mobile isolation and mobile high quality checking out procedure. In comparison to recent PBMCs, cryopreserved pooled PBMCs do away with the wish to adopt mobile isolation for every unmarried take a look at run. Because of this, the cells are to be had on call for every time a necessity arises and big choice of vials from one batch ensure a long run take a look at consistency. Lonza will additional distribute the Sanquin-branded PeliKine compact ELISA Kits which were validated to be used with the MAT assay. Along side Lonza’s checking out {hardware}, media and accent providing, drug builders and QC laboratories will now take advantage of a complete and optimized MAT answer this is consistent with regulatory necessities.

For more info about Lonza’s entire checking out product providing, please consult with https://bioscience.lonza.com/lonza_bs/CH/en/endotoxin-testing.

For info of Sanquin’s merchandise & products and services providing, please consult with https://www.sanquin.org/mat.

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