Explore the FDA’s new Plausible Mechanism Pathway and how it compares to accelerated approval, expedited programs, and other regulatory routes for rare disease therapies.
The FDA released three new draft guidances to streamline cell and gene therapy development. The documents outline innovative trial designs for small populations, expedited pathways for serious conditions, and improved postapproval methods for monitoring long-term safety and efficacy...
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Download our technote, Successful Development of Cell-based Potency Assays, to explore the essential role of potency assays in evaluating the biological activity of complex therapeutics, including cell and gene therapy products. This comprehensive guide draws on our extensive experience designing and validating custom potency assays, offering practical insights into assay formats, MOA selection, and relative potency determination...
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Next- and third-generation sequencing are vital for GMP, GLP, and clinical applications, but data integrity challenges and 21 CFR Part 11 compliance require secure instruments, validated workflows, and robust audit trails...
