Launched in 1989, Planova™ is the world’s first virus removal filter and has emerged as a significant technological advancement in assuring robust virus safety for the biopharmaceutical industry. Among filters offered in the product lineup, the Planova 20N filter, which employs cuprammonium regenerated cellulose hollow fiber membranes has demonstrated stable protein filterability for a wide range of solution conditions and is highly valued by the industry. Given the need to continually improve operational efficiency to meet current and future demands, significant effort has been made to add a new filter, the Planova S20N filter. Its use of superior cuprammonium regenerated cellulose that withstands higher operating pressure makes it simple for the post-use integrity test. Planova S20N shows robust virus removal capability, higher throughput, and stable protein filterability at higher operating pressures over a wider range of solution conditions and molecules (e.g. multi-specific antibodies). We will present the characteristics and results of customer-led evaluations and internal studies on Planova S20N filters. We will show how Planova S20N is up to the challenge of any customer virus removal process in order to ensure drug safety.

Speaker:

Tomoko Hongo-Hirasaki, Ph.D.
Lead Expert, Scientific Affairs, Global Marketing, Bioprocess Division
Asahi Kasei Medical Co., Ltd.

Cell line development scientists and upstream bioprocess engineers aim at optimizing biotherapeutics production processes to maximize drug product quality, yield, and manufacturing efficiency. Currently, information on critical process and product attributes required for informed decision making is often insufficient and not readily available. This has a negative impact on the process robustness, throughput, and outcome.

Direct measurement of cell culture media and product quality attributes (PQAs) has recently been offered thanks to the Waters BioAccord™ LC-MS system with dedicated workflows for process analytics of biopharmaceuticals. The BioAccord™ LC-MS can be directly coupled to multi parallel bioreactor systems, like the Sartorius Ambr® 15 or 250 HT platforms, for accelerated process development.

With this integrated solution, process engineers have direct access to the information they need to be in control: drug substance quality and yield can be maximized, process and product related impurities minimized, and more robust processes can be developed, thereby de-risking batch failure. This ultimately results in accelerated drug product development and manufacturing release from months or weeks to days, saving time and resources but more importantly enable faster delivery of safer treatments to patients.

Please join us as Magnus Wetterhall will present how Waters BioAccord™ LC-MS system offer enhanced capabilities for direct measurements of critical process and product quality attributes in cell line and process development and thereby enabling you to make more informed decisions with your own high-quality data.

Speakers:

Magnus Wetterhall
Global Marketing Manager, Bioprocess
Waters Corporation

Terence Teo, M.Eng.
Biopharma/BMR Market Development Manager, APAC
Waters Corporation

Viral safety and risks for Gene Therapy, how to improve pathogen safety of Gene Therapy.

Speakers:

Atsushi Iesato, Ph.D.
Manager, Scientific Affairs, Global Marketing, Bioprocess Division
Asahi Kasei Medical Co., Ltd.

Speaker:

Suman Das
Co-Founder of Mirai Foods
Mirai Foods

In viral vector production, achieving optimum quantitative harvest yield during rAAV cell lysis process remains an ongoing challenge. Certain techniques and materials currently in use have certain safety concerns and do not necessarily prevent vector precipitation and aggregation due to shear stress during processing.

In this webinar, a novel cell lysis solution that not only lyse the cells but also protects the viral vector from damage during processing will be discussed in detail. The webinar will examine several key advantages this novel solution demonstrates including:

• Efficient cell lysis across broad operating conditions
• Cell lysis efficiency comparable to a traditional cell lysis solution
• Protection of viral vectors enabling higher recovery compared to a traditional cell lysis solution

Key Learning Objectives:

• Gain insight to productivity and safety factors related to current rAAV cell lysis processes
• The importance of improved protection of viral particles during agitation and the need for solutions that reduce foaming and viscosity to minimize processing challenges
• How a novel cell lysis solution has been engineered to address these and other rAAV cell lysis challenges and is designed for use in current generation bioreactors and with other reagents in standard workflow such as endonuclease.

Speakers:

WonHyun Hwang (James)
Head of application AMEA
Avantor  

Tuhidul Islam
Sr. Manager- Bioprocess Applications
Avantor  

For many modern biopharmaceutical processes, manufacturers develop data-driven models using data analytics/machine learning (DA/ML) methods. The challenge is how to select the best methods for a specific dataset to construct the most accurate and reliable model.

This presentation describes the application of smart process data analytics software to industrial end-to-end biomanufacturing datasets for monoclonal antibody production to automate the determination of the best DA/ML tools for model construction and process understanding.

The application demonstrates that smart process data analytics software captures product- and process-specific characteristics for two different monoclonal antibody productions.

Speaker:

Moo Sun
Assistant Professor
Seoul National University