Celsius pre-design solutions for freezing and melting
A robust, complete, and scalable solution for frozen storage and frozen transportation.
Based on over 15 years of experience in the design of single-use freezing and thawing solutions, we have established Celsius pre-design solutions (PDS) for all processes requiring frozen storage and frozen transport, at both lab scale and manufacturing scale. Celsius PDS separates the downstream process and is equipped with the necessary functions for the safe transport of active pharmaceutical ingredients to pharmaceutical manufacturing facilities.
basic information
【Robustness confirmed down to -70℃】 ▪ A single-use freezing and thawing platform designed to maximize safety throughout the product lifecycle. ▪ Proven freezing and thawing performance protected by structural containers and complete logistics, with the S71 single-use bag validated through extensive low-temperature functionality qualification. ▪ The highest level of robustness enabling the frozen transport of expensive active pharmaceutical ingredients worldwide, validated according to ASTM D4169 Guarantee Level 1 (AL1). 【Meeting customers' needs for frozen storage and transfer】 Celsius PDS offers a range of general S71 films and all types of single-use containers that can be selected and scaled according to the process, from process development to clinical and commercial production. The feasibility can be easily assessed with process development tools.
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For more details, please refer to the PDF document or feel free to contact us.
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"We will send you a recorded video" Single-use system compliant with the new EMA Annex 1 Guideline.
Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. We will introduce the content of the revised EU GMP Guidelines Annex 1. While reviewing this content, we aim to deepen the relationship between Sartorius and our customers through mutual understanding, particularly regarding Quality Risk Management (QRM) and Contamination Control Strategy (CCS). Additionally, we will provide information on Sartorius's sterilization validation and the latest information on Extractables and Leachables (E|L), which we hope you will find useful. [Seminar Overview] ▪ Date: December 7 (Thursday) at 3:00 PM (approximately 30 minutes) ▪ Format: Webinar recorded broadcast [Japanese, Free] *We sincerely apologize, but participation from companies in the same industry and email addresses other than those of your organization is not permitted. Thank you for your understanding.
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[End] Innovation Forum 2023 "Simplification of pDNA|mRNA Manufacturing Process by Sartorius"
This event has concluded. *Please note that there are currently no plans for on-demand distribution. mRNA pharmaceuticals are attracting attention as a new modality for drug discovery. Sartorius has a wide range of technologies that cover the mRNA manufacturing process, including E. coli culture, pDNA purification, IVT reactions, mRNA purification, and freeze storage. In this forum, we will provide a meaningful discussion platform centered around topics such as "pDNA|mRNA Manufacturing Processes," "Sartorius Manufacturing Platforms," and "Application Examples," inviting guest speakers to give presentations and facilitating questions and interactions from participants. Special Lecture Kazuhisa Uchida, Graduate School, Kobe University Capacity [In-person participation] 35 people *If there are many applications, a lottery will be held. [Online participation] 200 people *Please note that applications from competitors and research companies may be declined in advance.
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[Sending recorded video] Bulk freezing process of pharmaceuticals using single-use technology.
Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. Freezing, storage, transportation, and thawing are important processes in the manufacturing of biopharmaceuticals. By utilizing the latest single-use technologies, we can implement freezing, thawing, and transportation processes in a robust, safe, and scalable manner. In this first webinar of 2023, we will introduce Sartorius's solution "Celsius" and its features. [Seminar Overview] ▪ Date: January 24, 2023 (Tuesday) from 3:00 PM (approximately 40 minutes) ▪ Method: Webinar recorded broadcast [Japanese, free of charge] *We sincerely apologize, but participation from companies in the same industry and email addresses other than those of your organization is not permitted. Thank you for your understanding.
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[On-Demand Streaming Available] International Webinar "Single-Use Systems for Freezing and Thawing: Advantages Compared to Conventional Bottles"
Participation in this webinar has ended. Those who wish to view it on demand can register through the details and application link. In this webinar, Marion Monstier and Sebastien Chaussin, product managers for freeze-thaw technology, will explain in detail the advantages of single-use containers compared to traditional bottles. They will also clarify important parameters to consider when validating such systems in actual processes. *Additional sessions will be held at times accommodating all time zones. We encourage you to participate and share your feedback. For those who could not attend on the day, a link to the on-demand archive will be sent to registered participants. [Main Learning Points] ▪ Advantages of single-use solutions over bottles ▪ Characteristics of single-use containers that can adapt to existing infrastructure at minimal cost ▪ Confirmation of parameters to consider when selecting single-use containers for freeze-thaw applications
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[Sending Recorded Video] Points to Consider in the Bulk Freezing Process of Pharmaceuticals Using Single-Use Technology
Registration for this webinar has closed. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. Cryopreservation technology is becoming an increasingly essential process in the management and storage of cells, viruses, and protein products during the pharmaceutical manufacturing process. Additionally, cryopreservation technology is widely used for transportation to connect manufacturing plants that are expanding globally. Recently, the necessity for ultra-low temperature transportation and storage of Covid-19 mRNA vaccines has brought attention to cryopreservation technology. Therefore, this webinar will focus on "Considerations for Freezing Processes Using Single-Use Technology." *We apologize, but participation using email addresses other than those from your company or organization is not permitted. Thank you for your understanding.
