Ab Inito Pharma Receives GMP Licence from the TGA for Manufacture of Clinical Trial Products

Ab Initio is pleased to announce that, after a successful regulatory audit, it has received a licence to manufacture Therapeutic Goods according to GMP from the Therapeutic Goods administration of Australia (TGA). Under it’s new TGA licence (no. MI-2021-LI-13035-1) Ab Initio Pharma Pty Ltd will be able to produce finished products for first in human and later stage clinical trials following GMP processes set-out by PIC/S 1 guidelines and international regulatory bodies.

Ab Initio will be able to formulate, manufacture, package, QC test and release for supply numerous product categories including Inhalation products, Nasal sprays, liquid suspensions, semi-solids, creams, gels, ointments, granules, and capsules. Processes include finished product manufacture, non-sterile fill, repackaging, trial blinding, in-house quality control and release for supply.

While Ab Initio will be able to manufacture across a broad range of product categories, the company also specialises in respiratory and nasal product development. The TGA licence will make Ab Initio the only pharmaceutical CMO in Australia that has the capability of developing complex dosage forms such as pressurised metered dose inhalers, dry powder inhalers and intra-nasal products from bench through to GMP manufacturing, QC and release.

Chief Executive Officer and Head of Production, Prof Paul Young said

‘Ab Initio works in partnership with numerous start-ups and SMEs who have a molecule but no product strategy or formulation. Ab Initio helps clients develop these innovations into finished products ready for the clinic. With Ab Initio’s GMP manufacturing plant now being fully operational, we now have the capacity to take innovations from our R&D facility into the clinic.

Chief Operating Officer and Head of Quality, Dr William Glover said

‘Ab Initio’s TGA Licence is a significant milestone in the development of our company. With Australia being a hub of innovation in the therapeutic arena, coupled with its location as a ‘go to’ place for clinical trials, having an onshore facility that can manufacture finished product for First in Human and later trials in a regulated environment, will significantly enhance Australia’s capability.’

Ab Initio looks forward to supporting innovators from across Australia and Internationally with quality products for their clinical trials.

About: Ab Initio Pharma is an independent pharmaceutical formulation R&D and Manufacturing company based in Sydney, Australia. Established as a spin-off from the University of Sydney in partnership with Sydney Local Health District and the peak industry body, ARCS, Ab Initio Pharma provides innovators across Australia and globally with a flexible platform to rapidly translate bench-top discoveries to clinical trial products and fully-fledged commercial pharmaceuticals.  Ab Initio is proud to be supported by MTPConnect, Australia's Growth Centre for the medical technologies, biotechnologies and pharmaceuticals sector. Youn can learn more about Ab Initio at www.ab-initio-pharma.com