In addition to upstream processing, capture, recovery and purification of biological products are essential components of the manufacturing value chain. Breakthrough technologies and novel developments are continually emerging to address issues of improving and ensuring protein quality while streamlining the steps required to achieve purity. One of the key challenges in removing a wide range of impurities, such as host cell proteins (HCPs), DNA, product variants such as charge variants, and other product-related species such as aggregates is to do so in a cost-effective manner.
Bio-Manufacturing as part of Biologics Manufacturing Asia is bringing together key stakeholders in Cell Line Development, Upstream Processing, Perfusion Technology, Downstream Processing, Chromatography, Viral Clearance amongst others to convene at the largest bioprocess business and technology convention in Asia Pacific! In 2020, 500+ biomanufacturing stakeholders from BIG Pharma, Biopharma, Contract Manufacturing Organisations, Academic & Research Institutes, Regulatory Authorities across Singapore, South Korea, Taiwan, Japan, Australia, India, Indonesia, Malaysia, and China will gather. The focus of the event would be to discover, discuss and debate how best to meet the demands of the expanding cell culture market, expanding the purification toolbox and the technologies of affinity chromatography, clarification, depth filtration, new membranes, flocculation, developing processes for emerging modalities such as cellular and gene therapies, bispecifics, and fusion proteins!
CELL- LINE DEVELOPMENT & CELL-CULTURE OPTIMIZATION
- Leveraging CRISPR/Cas9 Technology to Develop Site Specific Integration of Transgenes
- Next Generation Sequencing (NGS) to Prove Clonality of Legacy Production Cell Lines
- Assessment of the injection performance of a tapered needle for use in pre-filled biopharmaceutical products
- Increasing Final Antibody Concentrations with a FedBatch Process Hyper Osmotic Resistant CHO Host Cells
- Use of ATF Perfusion at the n – 1 stage To Achieve Viable Cell Densities
- Approach to Identify and Control Product Attributes in Cell Culture Perfusion System
- 5 N-1 (3,000L) Perfusion with Alternating Tangential Flow (ATF) Device Cultivates Higher Cell Culture Densities while Retaining High Cell Viabilities
PROCESS DEVELOPMENT and COGS REDUCTION CASE STUDIES
- Strategies to Accelerate Process Development and Reduce Manufacturing Cost for Biologics: A Case Study by Chugai Pharmaceutical
- ‘Bulk Drug Substance Manufacturing Start Up Case Study for Accelerated Speed to Market Manufacturing Capabilities’
- AI Tools Available for Process Control
- At-line Isoelectric Chromatofocusing (ICF) Method for the Analysis of Monoclonal Antibody Charge Variants
SINGLE-USE SYSTEMS IN DOWNSTREAM PROCESSING
- Smart Downstream Processing of Biologics using Continuous Operation, Single-Use Technology and Mechanistic Models.
- Isolation of anti-extra-cellular vesicle singledomain antibodies by direct panning on vesicleenriched fractions
- Designing a Single-Use Virus Filtration System for Large Batch Volumes while Maintaining Sterility and Reducing the Risk of Handling Errors
- Improved Primary Clarification Depth Filters