Mixed mode Chromatography in Purifying biologics – Overview
15th November 2018 | 3PM Indian Standard Time, 9.30 AM GMT, 10.30 AM CET | Vivek Halan, Senior Scientific manager at Zumutor Biologics Pvt Ltd |WATCH FOR FREE
Market for therapeutic proteins such as monoclonal antibodies (mAbs), growth hormones, other recombinant therapeutic proteins has grown tremendously in the last two decade. To compete in the biopharmaceutical market, we should identify, develop the high product producing clone and find the best conditions to purify to highest purity, good recovery with good quality in the early stage of development. The process should be robust. Biologics are increasingly being developed by many biopharma companies and used as therapeutics for treating various diseases worldwide. There is a lot of scope to improve in biologics story. Biologics are approved through stringent regulatory pathways in highly regulated markets such as US, EU, Japan, Canada and Australia and many other countries.
With recent advancements, biologics are produced in high quantity ranging from 12 to 15 g/L. This gives rise to many challenges to downstream processing. Generally, maintenance of the chromatography resin performance is also a major concern in large-scale manufacturing of biologics. One of the critical step is Capture stage- Protein A Chromatography which incur at least 40 to 50 percentage of downstream processing cost. Many biopharma players are working towards Non-Protein A downstream process development. Multimodal chromatography, one such chromatography can be a best replacement to Protein A Affinity chromatography. Mixed mode or multimodal chromatography involves selective interaction between chromatography ligand with the analyte molecule through different types of interactions which can be either ionic, hydrophobic or may involve hydrogen bonding, sometimes Van der Waals interactions. Many MMC resins are commercially available and this type of chromatography can be used as a Capture step to purify monoclonal antibodies and also can be employed in intermediate and polishing step, where MMC can remove endotoxins, HCDs better than conventional ion exchange chromatography. The elution behavior of MMC using either pH or salt gradient is better in terms of impurities removal and product recovery. The binding capacities of some mAbs are higher in MMC resins than Protein A resins. MMC can efficiently separate insoluble aggregates than other chromatography and used widely in biosimilar development; still there is a requirement to understand and demonstrate the efficiency in commercial aspect.
This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proteins.
Presented by Vivek Halan, Senior Scientific manager at Zumutor Biologics Pvt Ltd
Vivek Halan has a post graduate degree in Biotechnology from Bharathidasan University in Trichy, Tamilnadu. He was awarded Gold medal for securing highest aggregates in M.Sc Biotechnology. He has around thirteen years of experience in Downstream Process Development of various products in Oncology, Diabetes, Osteoporosis, Metabolic Disorder, Inflammation, Rheumatoid arthritis. He has worked for various companies such as Magene Life sciences Pvt Ltd, Avesthagen Ltd, and Syngene International Pvt Ltd where he was involved in downstream processing of various biologics, biosimilars, NBEs and few other recombinant proteins. He received few R &D Star awards for his contribution in developing various products during his tenure at Syngene.
Moreover, he was also involved in recombinant protein expression in bacterial cells, monoclonal antibodies expression in mammalian cells lines in laboratory scale. He has been involved in technology transfer for various biologics are in different stages of clinical trials. Currently, he is heading downstream process development department at Zumutor Biologics Pvt Ltd, Bangalore.