By Lluis M. Martinez, CSO Sepmag
April 3rd, 2013
Last March I was invited by MerckMillipore China to contribute to the seminar they organized for the CACLP 2013. That gave me the opportunity to interact with the local IVD companies manufacturing magnetic bead kits.
As expected, we found a very dynamic, highly skilled and well informed audience. The problems among most of the 100 attendees to the seminar were the same as those of their competitors in USA, Europe or Japan. Once the right magnetic beads were chosen and the coating process developed, they found it hard to transfer the magnetic separation protocols from the validation batch to large production lots.
Typical problems include increased losses and irreversible bead aggregation. These two specific problems generate anxiety at the managerial level, as they delay production ramp-up to meet market demands. Solving these issues requires production and R&D managers working under pressure with a tight schedule, and usually implies developing the production process from scratch, since the validation results at small volumes are useless at the new lot volumes.
We hope to have helped by explaining the physics behind the biomagnetic separation process and how achieving a homogenous magnetic force helps to establish working conditions under which it is easier to transfer the validation process to larger volumes. I also briefly introduced how to monitor the separation process, and a procedure for early detection of irregularities (e.g., magnetic bead characteristics, concentration or buffer characteristics).
Later in the day I had the opportunity to discuss specific issues with customers in head-to-head meetings at the MerckMillipore booth. I hope our technology will help more Chinese IVD manufacturers meet their production volumes, as already occurred with CapitalBio, Sichuan Maker Science and Technology, Leadman or Beijing Bio-Ekon Biotechnology.
Last but not least, I would like to thank Merck Millipore’s China team: Zhu-Wei, Alex Hu and Amanda Xing (amanda.xing[at]merckgroup.com, thanks for the pictures!), for their hospitality and the fantastic organization of the event. In Xi’an I also had the pleasure of meeting my old friends from ESTAPOR, Dr. Richard Vidal and Dr. Fabrice Sultan, who introduced me to their Chinese colleagues.
If interested, you can download my presentation (both in English and Chinese) here
Lluis M.Martinez, PhD, is the CSO and founder of Sepmag.