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Characterization of Active Substance and Comparability

Making changes to the manufacturing process/product is an inevitable part of process development with the goal of making a better product. There is a risk if manufacturing changes are made late in the clinical trials that they could potentially change the product’s critical characteristics...

1311416.mp4


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Qualification, Regulation of Gene Editing Tools in Cell & Gene Therapy

Recent advances in genome editing technologies have substantially improved our ability to make changes in the genomes of eukaryotic cells. Viral vectors and programmable nucleases are already revolutionizing our ability to interrogate the function of the genome. This session provides an overview...

1311411.mp4


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Manufacturing Profess Validation - Consideration for Validation of Autologous Products

Process Validation – it has to happen! Join us to hear regulatory perspectives and real-world examples of considerations specific to autologous products, including both cells and tissues. Are normal donor cells ok to use? What risks are associated with validating your process using cells or...

1311424.mp4


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Qualifications of Ancillary/Raw Materials for Clinical Use

This session will walk through the step by step approach to qualify Ancillary/Raw Materials for Clinical Use. The presentation will focus on the following: Step by step qualification pathway Region specific regulations and guidance Common industry issues Case studies #Regulatory ...

ISCT Webinar 11.8.2017 Recording.mp4


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Gaps in the Knowledge of Human Platelet Lysate as a Cell Culture Supplement for Cell Therapy

Fetal bovine serum (FBS) is used as a growth supplement in a wide range of cell culture applications for cell-based research and therapy. However, as a xenogenic product, FBS can potentially transmit prions and adventitious viruses as well as induce undesirable immunological reactions. In...

Recording (6).mp4


Library Entry
Critical Ancillary Materials for Cell & Gene Therapies: Addressing the Impact of Human Serum and Serum Alternatives

Ancillary materials are critical to the long-term success of your cell and gene therapy product. Critical considerations for ancillary materials of biological origin include sourcing, manufacturing, safety and performance consistency. In this webinar, we will discuss AB serum as a cell media...

ISCT PPD Webinar Recording_10.30.2019.mp4


Library Entry
Chemically defined media for T cell-based therapies. Regulatory and technical considerations.

Cell therapy is a promising emerging industry that offers unprecedented challenges to manufacturers and regulators. ATMP guidelines present risk management as a key tool to address challenges associated with converting complex biology into compliant processes. In this context, the use of serum...

Webinar Chemically defined media for T cell-based therapies-20201118 1700-1.avi