Overcoming Challenges in Potency Assay Development Using a Matrix Approach
Title: Potency assay development for advanced therapy medicinal products Speaker: Dr. Sascha Karassek (Charles River Laboratories) Date and Time: March 13 (Thursday) 15:00 (Duration: approximately 45 minutes) Language: English (with English subtitles) Application Deadline: March 13 (Thursday) 9:00 AM Viewing Method: A URL for viewing will be sent by the morning of the event day. *You can view it from anywhere as long as you have an internet connection.
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basic information
The measurement of potency for advanced therapy medicinal products (ATMPs) is both a requirement and a challenge under the current standards for pharmaceutical manufacturing and quality control (cGMP). In this webinar, Dr. Sascha Karassek, an R&D Scientist at Charles River Laboratories Germany GmbH, will provide an overview of in vitro potency assays and regulatory considerations, as well as introduce a matrix approach to evaluate various aspects of ATMPs at the transcription, translation, and functional levels. He will also discuss the measurement of biological activity in cases of AVV/ lentivirus and plasmid DNA using a matrix approach, employing a multi-detection mode plate reader Spark (compliant with 21 CFR part 11).
Price information
Free, pre-registration required
Delivery Time
※The broadcast will be on March 13th (Thursday) at 15:00.
Applications/Examples of results
Recommended for the following individuals: Those interested in potency assays Those interested in cell-based potency measurements related to ATMPs or cell and gene therapies Those who have concerns about the design of potency assays for ATMPs Those engaged in quality assurance/quality control in a GMP environment
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Company information
Tecan is a company that was established in Switzerland in 1980, specializing in the manufacturing and development of life science research support equipment. With the support of many customers, we were able to celebrate our 30th anniversary in Japan in 2022. Tecan Japan operates two businesses. One is the life sciences business, which delivers Tecan-branded products such as automated pipetting systems and microplate readers to end-users. The other is the partnering business, which provides components and equipment as OEM products for partner companies. Our customers span a wide range of fields, including disease research, drug discovery, biotechnology, clinical testing (such as cancer diagnosis, infectious disease diagnosis, and testing centers), scientific analysis, and robotic surgery. Our mission is to improve people's lives and health. Tecan Japan aims to contribute to global health care innovation from the life sciences industry to clinics by supporting our customers' daily activities.
