Download the paper for free 👉 bit.ly/3WV3lED
Ensuring the safety of cell and gene therapy (CGT) products from viruses is a unique challenge.
The viral vector is a critical component of both in vivo and ex vivo gene therapies. Regulatory authorities expect the viral safety and contamination controls for cell and gene therapy manufacturing to be ensured through a comprehensive program, referred to as the three-pillar approach:
- Sourcing materials
- Virus testing at various manufacturing stages
- Removing and/or inactivating adventitious viruses and helper viruses through the manufacturing process
Like other biological products such as monoclonal antibodies, viral clearance strategies can only be implemented if they do not affect product quality. When options for viral clearance are limited, the focus shifts to testing and controlling raw materials, reagents, and the manufacturing process to ensure virus safety.
In this webinar, members of the team present the key points covered in the paper, providing a valuable perspective, including:
- The current regulatory landscape
- Sources of viral entry
- Phase-appropriate considerations
- Analytical methods for evaluation of viral clearance
- Modes of viral clearance (inactivation and separation)
Our speakers 🗣️
Marian McKee, @EurofinsBPT
Kathryn Remington, @Merck
Daniel Hurwit, @BristolMyersSquibb
Chapters:
0:00 Webinar and BioPhorum introduction
6:46 Regulatory landscape
9:26 Sources of viral entry
11:24 Phase-appropriate considerations
16:29 Key aspects to consider when designing a viral clearance study
19:27 Case studies of three VC mechanisms for an AAV product
28:25 Results from the industry survey
#biophorum #ATMP #AdvancedTherapyMedicinalProducts #advancedtherapies #advancedtherapy #cgt #viralclearance
Негізгі бет Current methods and factors to take into account for viral clearance in cell and gene therapy
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