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Summary
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Course of validation in cell and gene remedy improvement is complicated and filled with uncertainty. On this comparatively untested area, figuring out and using one of the best practices to advance a remedy from idea to market can really feel unattainable – but it surely doesn’t must be!
Lenmedly
, a hematopoietic stem cell (HSC) gene remedy from Orchard Therapeutics, is the primary gene remedy to attain FDA and EMA approval for therapy of metachromatic leukodystrophy (MLD).
AGC Biologics’ skilled Cell and Gene CDMO group in Milan supplied end-to-end help for the drug product by way of improvement, medical phases, CMC technique, and commercialization within the context of regulatory approval.
We’ll stroll by way of the method our main group makes use of to supply lentiviral vector-based merchandise that may scale at any stage and meet rigorous regulatory calls for.
Highlights
- Investing to empower your Stage 1 actions
- Strategic planning of Stage 2 and three timelines
- Leveraging the information and information out there for the platform course of method
- Steady help from analytics: platform strategies and in-house testing are most popular
- Creating a robust scientific and statistical justification of the specs set
- Understanding remaining issues for regulatory evaluation and approval phases
Francesca Rossetti
Analytical Methodology Improvement Director, AGC Biologics
Francesca began at AGC Biologics in 2004 and later grew to become the Head of Analytical Improvement in 2017. Her work focuses across the design of analytical strategies for characterization and launch of retroviral, lentiviral, adeno-associated vectors and of cells in compliance to GMP guidelines and ICH tips. In 2021 she grew to become a professional individual for the AGC Biologics’ Milan website.
She has experience from product improvement and pre-clinical initiatives all the way in which to market, actively contributing to drawing up and revising regulatory documentation, corresponding to: IMPD, IND, CTD, BLA submissions, defining product validation and CMC characterization methods. She holds 20 years of expertise working in a global undertaking administration group working with improvement and certified analytical strategies prepared for ATMP’s launch, assuring product high quality.
Francesca holds a level in Organic Sciences from the College of Pavia and a second stage grasp in “Expert in analytical chemistry for pharmaceutical industry”.
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Monika Pema
Senior Supervisor MSAT, AGC Biologics
Monika began at AGC Biologics in 2015 as a technical Challenge Supervisor after 10 years in educational scientific analysis. Throughout these years she guided and supported the collaboration between AGC Biologics and a number of worldwide purchasers working totally different CGT initiatives, overlaying early improvement by way of medical phases.
In 2021 she joined the MSAT-process validation group the place her aim was to construct a brand new unit and drive the preparation of 4 totally different PPQ campaigns for the validation of lentivirus manufacturing processes, for each EMA and FDA functions. She actively contributed to the definition of the validation methods by consistently working with purchasers. Her experience was additional expanded following the post-approval administration of business merchandise, together with lentivirus and retrovirus manufacturing processes and HSC Drug Product manufacturing. She contributed to the revision of regulatory paperwork on behalf of purchasers and throughout the evaluation section by the regulatory companies she supported the purchasers by offering technical inputs info requests. She was additionally concerned in high quality and regulatory inspections offering key help as an SME for course of validation matters.
Monika holds a level in Organic Sciences from the College of Milano-Bicocca and a PhD in Molecular Medication from the San Raffaele College of Milan. She has an government grasp in “Leadership, Empowerment & Change Management” from 24ore Enterprise College.
The put up Webinar: Uncharted paths: efficiently validating your LV gene remedy product course of to realize FDA and EMA Approval appeared first on Greatness.bio.
