MAb characterisation course could reskill small molecule API workers, NIBRT
The course set is being run by NIBRT – Ireland’s Government-funded National Institute for Bioprocessing Research & Training – and is intended to teach those currently working in small molecule active pharmaceutical ingredient (API) quality or technical roles more about high end analytical methods for monoclonal antibody (mAb) characterisation.
“An individual with qualifications and experience in a small molecule manufacturing would have many of the key competencies required for a role in biologics manufacturing,” projects director Killian O’Driscoll told Biopharma-Reporter.com.
“Depending on the role they’re interested in, they would need to cross skill in key areas such understanding the biological process, cell culture, protein biochemistry, protein purification, aspectic manufacturing.”
Over the course of two days next month, participants will develop a good understanding of the differences between small and large molecule quality control testing, identify transferrable skills and be introduced to new bioanalytical techniques, O’Driscoll said.
They will also become aware of the orthogonal analytical approaches used for the characterisation of mAbs and be given introductory practical experience in the practical application of methods for large molecule characterisation using both intact protein and peptide centred analytical strategies, he added, through a curricula designed and reviewed by a panel of industry experts.
The reskilling of workers comes as Ireland, a traditional hub of small molecule manufacturing, benefits from a wealth of biopharma investment.
While O’Driscoll said the small molecule sector continues to perform well, there have been a number of plant closures announced recently, for example by Roche and MSD (known as Merck & Co. in North America).
“[But] the biologics industry in Ireland continues to grow strongly with an estimated $10bn in capital investment in the last 10 years with recent announcements from Shire, Regeneron, BMS, Alexion among others.”
The course takes place on July 5-6 at NIBRT’s centre in Dublin.
NIBRT and Thermo Fisher
In related news, NIBRT has inked a deal to develop workflows usingThermo Fisher's biomolecule column range, liquid chromatography systems and Orbitrap high resolution mass spectrometers.
"This collaboration is important because it enables our team to access Thermo Fisher’s world leading columns and analytical instrumentation to develop total analytical solutions and streamline the characterisation of complex biopharmaceuticals," said Jonathan Bones, principal investigator, NIBRT’s Characterisation and Compatibility Laboratory.
"The availability of total analytical solutions to scientists across the world is empowering and motivates us at NIBRT to continually perform excellent impactful research."
