Best Practices of Downstream Protein Purification and Product Concentration
12th October 2022 | 3:30pm IST / 9:00pm CST / 11:00am BST / 12:00pm CET / 6:00am EDT / 3:00am PDT | Krishnamurthy Venkatesan, Downstream MSAT Lead, Director at Biocon Biologics, Sofie Östemar, Product Manager for Connected & Continuous Downstream Processing and Henrik Ihre, Ph.D. Director Strategic Technologies at Cytiva and Nigel Jackson Principal Engineer, Bioprocessing R&D at Pall Corporation |WATCH FOR FREE
Downstream protein purification and product concentration is known to be the most challenging part of the process development. It is also known that the Downstream process development is critical to ensure protein drug’s quality, safety & efficacy meet regulatory expectations. When initiating the development, the Chemistry, manufacturing and controls considerations for process development and manufacturing must include molecule complexity. Raw materials, process development. Equipment and manufacturing, Quality and Regulatory affairs
The critical factors for development and manufacturing is performing stage-wise assessment on Product development, analytical and process development and not the least, the manufacturability assessment. The expected qualities of a superlative process shall include increased capacity, flexibility, cost-effectiveness, controllability, scalability, and efficiency
However, general challenges exist in downstream process development involving,
- Balancing higher cost chromatography resins and solvents
- Constrained purification space for molecules prone to degradation at wide range of pH and temperature
- Process fit to multi-product facility,
- PAT availability to accelerated processing
- Adaptation of new technologies one of smarter way to address the challenges:
- Non-Protein A process
- use of next-generation chromatography resins
- Continuous processing for capture, intermediate purification, Viral clearance
Presented by Krishnamurthy Venkatesan, Downstream MSAT Lead, Director at Biocon Biologics.
Krishnamurthy Venkatesan is a Biopharma professional with protein purification expertise gained through 20 years of experience on wide range of responsibilities. He earned his degree in Chemical Engineering followed by master’s in biotechnology from Anna University. He is currently the Lead, Manufacturing science and technology for Downstream at Biocon Biologics, Malaysia. Krishnamurthy started career as Downstream process development scientist involving chromatography, enzyme-based reaction, crystallisation for proteins and peptides as biotherapeutics, and further on, into expanding knowledge towards technology transfer, manufacturing support and CMC.
During the path, he gained understanding on Quality by design (QbD) approach identifying critical quality attributes and Critical process parameters, process design space and In-process controls, utilising assessment-based scale-up methodology and mitigation plan. Later, this enabled him to lead a team of scientists from early to late-stage process development, pilot scale studies towards scale-up, technology transfer, process improvements. He was involved in multiple pre-approval and periodic inspections by FDA, EMA and other agencies leading to successful approval of Biosimilars developed and scaled-up to manufacturing and gained thorough knowledge on technology transfer to large scale manufacturing and continuous process improvement through process excellence including effective Dossier and comparability package for Agency approvals of multiple biosimilars.
Continuous chromatography: one tool in the process intensification toolbox
Sofie Östemar, Product Manager for Connected & Continuous Downstream Processing at Cytiva
Sofie Östemar is Product Manager for Connected & Continuous Downstream Bioprocessing at Cytiva. She is responsible for the ÄKTA™ pcc and BioProcess™ pcc chromatography systems. She is also responsible to ensure a holistic perspective of the downstream connected process offerings at Cytiva, including Process Intensification solutions. She has been with Cytiva for 10 years, joining as a global product manager and has extensive experience from working with all the hardware businesses across Cytiva.
Sofie holds a Master’s degree in Engineering Biology from University of Linköping, Sweden with thesis work made at University of Natural Resources and Life Sciences in Vienna, Austria.
Navigating the diverse pipeline with chromatography innovations
Henrik Ihre, Ph.D. Director Strategic Technologies at Cytiva
Henrik Ihre has his roots in biopharma, leadership and product development for the biopharma downstream industry in specific. He is motivated by bringing new solutions to the market enabling the invention and manufacturing of new pharmaceuticals for patients developed by partners of Cytiva.
He’s been the Director of Strategic Technologies since March 2020 with a specific knowledge and background in the Downstream purification of biopharmaceuticals since 20 years back in time.
Henrik joined legacy Amersham Pharmacia Biotech in August 2000, following its acquisition by GE Healthcare in 2004. His career has been devoted to the design and development of several purification products enabling the manufacturing of life changing drugs on the market. For more than ten year he headed and expanded the custom consumables organization offering customization within resins and columns.
Henrik holds a Ph.D. in synthetic organic polymer chemistry from the Royal Academy of Engineering (KTH) in 1998 and spent two years as a Post Doc graduate at UC Berkeley in California, USA.
Virus Filtration
Nigel Jackson Principal Engineer, Bioprocessing R&D at Pall Corporation
Since his PhD in Biochemical Engineering, Nigel Jackson has over 10 years of experience in Biotech Process R&D within Pall. Nigel has multiple publications and conference presentations demonstrating a deep understanding of virus filtration and general bioprocessing. He has directed this knowledge into helping Pall develop robust and effective new virus filters and many other Pall products and applications. He has also recently taken on the role of Visiting Lecturer at University College London.
Sponsored by Pall Corporation and Cytiva
About Pall
Pall Corporation provides critical filtration, separation and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe.
Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers’ biggest fluid management challenges. And in doing so advance health, safety and environmentally responsible technologies.
About Cytiva
Cytiva is a global life sciences leader dedicated to advancing and accelerating therapeutics. Cytiva is a trusted partner to customers that undertake life-saving activities ranging from biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients. We have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Learn more at www.cytivalifesciences.com