Scientific Comprehension of Cell Line Development Strategy Based on the CHOZN-GS System

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Watch the presentation of this webinar here: https://bit.ly/3kO8Yku Stable outcomes in cell line development rely heavily on the optimization of process factors in the initiation phase. This webinar will help give you an understanding of the scientific background of these factors so you can develop a flexible strategy that is appropriate for your environment. Stable cell line development (CLD) for recombinant glycan proteins – despite its 40-year history - still suffers due to unexpected and vulnerable outputs caused by the influence of unpredictable traits of the base host cell line. However, recently - through the CHOZN-GS system - we observe better CLD performance than other CHO systems in terms of time, cost, titer, stability, and scale-up, due in part to its robust genetic stability. In particular, we find that optimization of key CLD process factors at an early stage have a large impact on the final outcome. In this talk, we will share how CLD strategies can be flexibly optimized under given conditions through an understanding of the scientific context. In this webinar, you will learn: • Screening & selection strategy of "easy to express Fc-fusion protein" structure • Optimization strategy of major CLD process factor Presented by: Dr. Young Min Oh Senior Director, GI Innovation

Healthcare

The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada.
28th September 2021

The life science business
of Merck KGaA, Darmstadt,
Germany operates as
MilliporeSigma in the U.S.
and Canada

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*Reference
• Barry Cherney, et al., Myths, Risks, and Best Practices: Production Cell Line Development and Control of Product Consistency During Cell Cultivation., BioProcess
International, September 19, 2018.

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*Reference
• Xu N, et al., Comparative Proteomic Analysis of Three Chinese Hamster Ovary (CHO) Host Cells., Biochem Eng J. 2017 Aug 15;124:122-129.
• Kaas CS, et al., Sequencing the CHO DXB11 genome reveals regional variations in genomic stability and haploidy., BMC Genomics. 2015 Mar 8;16:160.
• CHOZN Platform Technical Bulletin

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*Reference
• Kurosaki H, et al., Integration-free and stable expression of FVIII using a human artificial chromosome., J Hum Genet. 2011 Oct;56(10):727-33.
MTX

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*Reference
• Kim SJ, et al., Cytogenetic analysis of chimeric antibody-producing CHO cells in the course of dihydrofolate reductase-mediated gene amplification and their stability in the
absence of selective pressure., Biotechnol Bioeng. 1999 Sep 20;64(6):741-9.

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• CHOZN Platform Technical Bulletin

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• Amedeo Cappione 3rd, et al., Int J Proteomics. 2012;2012:473843.

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• Rachel Novak, Regulatory Perspective on the Evaluation of Clonality of Mammalian Cell Banks, January 23, 2017

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The vibrant M, CHOZN-GS, UCOE, EX-CELL, and SAFC are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their
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Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release. Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines. In this webinar, you will learn about: • Regulatory framework for adenoviral vector products • Considerations for lot release testing of adenoviral-based therapies • Advantages of a rapid method for RCA testing on production lot material Presented by: Axel Fun, Ph.D., Principal Scientist Alberto Santana, MBA, Product Manager, Biologics Biosafety Testing

Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ...

MilliporeSigma

Watch the presentation of this webinar here: https://bit.ly/3vQyN7K Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations. Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects: • excellent sugar-like taste profile • outstanding sweetness factors • use effectiveness • enhanced stability We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception. In this webinar, you will learn: • How to optimize the patients' taste experience of your pharmaceuticals • How sweeteners can be differentiated by their sensory profiles and features • How our new product offering Neotame can be effectively used in your targeted formulations Presented by: Almut von der Brelie, Senior Manager Strategic Marketing, Excipients for Solid Applications

The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...

MilliporeSigma

The Developability Classification System (DCS): Enabling an Optimized Approac...

MilliporeSigma

In this webinar, you will learn about: The advantages of using advanced intermediates to develop ADC therapies How to increase ADC solubility and efficiency Fast, small-scale ADC library generation Seamless supply chain with reduced complexity and regulatory support The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window. Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.

How to Accelerate and Enhance ADC Therapies

MilliporeSigma

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