Regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
To ensure patient safety, regulatory agencies mandate mycoplasma testing for the release of products. Conventional mycoplasma testing takes at least 28 days, resulting in long lead times for product release. Meanwhile, rapid polymerase chain reaction (PCR)-based mycoplasma tests have emerged and are accepted by health authorities for testing of monoclonal antibody products (mAbs) as well as advanced therapy medicinal products (ATMP), also known as cell and gene therapies.
Several PCR-based assays are commercially available, yet these typically still require extensive hands-on-time for sample preparation and nucleic acid extraction, specialised personnel and dedicated test areas.
A novel PCR-based technology that overcomes these hurdles was tested and validated at Janssen recently. The biggest advantage of this technology over other PCR-based methods is the ease of use; comprising a nearly fully automated sample preparation and nucleic acid extraction followed by a nested multiplex (RT-)PCR to amplify and detect mycoplasma RNA/DNA. Furthermore, results are available in less than two hours.
Janssen’s generic method validation, including a comparability study between the conventional mycoplasma assay and the automated technology, was successfully completed for a representative mAb. In addition, suitability testing could be finalised on several other products.
This webinar presents the validation approach and regulatory submission strategy for implementation of the new PCR-based technology for mycoplasma testing of different products, discussing the challenges encountered and how they were addressed.
The presentation covers the collaborative effort between different functions across Janssen R&D, Janssen Supply Chain (JSC) and the vendor, and includes J&J’s future implementation of the automated PCR technology at multiple (bio)pharmaceutical drug substance production and ATMP drug product sites.
In this session, you’ll discover:
- - The importance of co-operation with different stakeholders, including the regulatory department
- - Why having a clear validation and implementation strategy in place in a company with a very diverse product portfolio is critical.
Dr Heike Merget-Millitzer, CoE Microbiology Lead within Janssen, Pharmaceutical Companies of Johnson & Johnson
Karen De Roy, Microbiology Expert within Janssen, Pharmaceutical Companies of Johnson & Johnson