bioMérieux and AnaBioTec Announce Partnership to Support the Implementation of Rapid Mycoplasma Testing
In May 2024, bioMérieux entered into a partnership with AnaBioTec, an analytical service provider for pharmaceutical, biopharmaceutical and cell-based drugs, from early to late phases of development. Both companies intend to advance and transform Mycoplasma testing for the biopharmaceutical and Cell & Gene Therapy (CGT) industries, in Europe.
Nucleic acid amplification technology (NAT) could revolutionise Mycoplasma testing for the CGT and biopharma industries. The current testing approach is highly complex and with lead times of nearly a month, represents a bottleneck for manufacturing processes and rapid access for patients.
While NAT’s remain alternative methods, their validation can pose a significant hurdle for adoption. By creating a complementary partnership between bioMérieux and the validation expert AnaBioTec, a compliant pathway is offered to implement and qualify BIOFIRE® Mycoplasma quickly and easily. This fully automated PCR system from bioMérieux provides simple, accurate, rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and for final product release.
BIOFIRE® Mycoplasma test results are available in around an hour and, the test can be performed by anyone, at any time. Implementing this rapid test could help improve the median turnaround time for CGT’s and enable biopharma manufacturing milestones to be respected. This partnership with AnaBioTec supports the ability to realise these benefits.
As an ally in advancing quality for the pharmaceutical industries, bioMérieux provides rapid, highly accurate methods to reduce contamination risks, boost operations efficiency, facilitate regulatory compliance, and empower smarter, data driven decision-making.
