Rapid mycoplasma PCR QC testing for cell and gene therapiesPublished: December 2, 2019
Rapid microbiological methods (RMMs) are essential for state-of-the-art manufacturing efficiency of cell and gene therapies because traditional testing methods do not provide shorter testing timelines and lower sample volume utilization. Some cell and gene therapies involve a manufacturing process and release timeline of just a few days making third-party testing impractical. There are ways to incorporate RMMs for QC testing, such as using a nucleic acid amplification technique as an alternative mycoplasma testing system after appropriate product-specific validation. Uncertainty around supplier selection, method validation, and costs associated with RMM implementation impede cell and gene therapy manufacturers from adopting these RMMs for QC testing. This webinar provide insight on the related issues around implementing a rapid mycoplasma PCR QC test in cell and gene therapy manufacturing to help push innovative rapid microbiological methods forward in a field that uniquely needs them.
- Review roles and responsibilities of suppliers, cell and gene therapy manufacturers, and regulators
- Discuss the value of using risk assessments for selecting a suitable commercially available rapid mycoplasma test for cell and gene therapy products
- Share relevant regulatory resources on using rapid PCR mycoplasma test as an alternative to a traditional testing method
- Case study presentation on Roche MycoTOOL Mycoplasma Real-Time PCR Kit for cell therapy QC
Professor Renate Rosengarten, DVM, PhD Professor and Chair of Bacteriology & Hygiene University of Veterinary Medicine Vienna
Prof. Renate Rosengarten’s career originated from her academic research work which is for more than 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover in Germany, the University of Missouri-Columbia in the US, and the Hadassah Medical School of the Hebrew University in Jerusalem, Israel. Since 1996 she has been Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria. Besides her numerous former functions and activities in organizations and committees, such as President of the International Organization for Mycoplasmology (IOM), President of the Austrian Society for Hygiene, Microbiology and Preventive Medicine (ÖGHMP), Scientific Advisory Board Member of the German Robert Koch Institute (RKI) in Berlin, and Working Group Leader of the Mycoplasma Task Force of the Parenteral Drug Association (PDA), Prof Rosengarten has longstanding entrepreneur and business experience in the area of mycoplasma safety testing. In addition to her academic duties as mentor, lecturer, reviewer, scientific advisor, and committee member, Prof Rosengarten serves since 2004 as an independent mycoplasma expert, key opinion leader and consultant for biopharma, biotech and cell therapy companies under her own international brand Mycosafe® and has recently established a consulting enterprise.
Dr. Angeliki Grammenos, Regulatory Affairs Manager, Celyad
Angeliki has held positions in academia and biopharma, with a special focus in cell therapy.
Angeliki is a physicist by training and has a PhD in biophysics specialized in cell biology. She left her teaching position at the University of Liège in 2012, to join the international office of Doctors Without Borders where she assisted the Ethical review board as well as the Quality Assurance department of the movement. In 2015, she joined Bone Therapeutics S.A, a biopharmaceutical company dedicated to the development of cell therapy products based on autologous and allogeneic adult stem cell technology to treat unmet medical needs in the field of bone disease where she led the RA Department. In 2018, Angeliki joined Celyad, a biopharmaceutical company specialized in autologous and allogeneic cell therapy. Celyad’s core business lies in immune-oncology and the development of NK-receptor based CAR T therapies.