Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
News|Articles|February 27, 2023
- Pharmaceutical Technology's In the Lab eNewsletter, March 2023
- Volume 18
- Issue 3
Eurofins Viracor Launches Test for Assessing Expansion and Persistence of CAR-T Therapy in Cancer Patients
Author(s)Pharmaceutical Technology Editors
Eurofins Viracor ExPeCT CAR-T qPCR assay is a tool designed for monitoring and optimizating CAR-T therapies.
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Eurofins Viracor, a Eurofins company specializing in testing for infectious diseases, immunology, and allergy, launched in February 2023 its Viracor ExPeCT chimeric antigen receptor T-cell (CAR-T) multiplexed quantitative real-time polymerase chain reaction (qPCR) assay. The tool is designed to monitor and optimize CAR-T therapy involving patients with pre-B cell acute lymphoblastic leukemia and B cell lymphomas.
According to a press release from Feb. 16, 2023, the test is designed to provide clinicians with an accurate and comprehensive assessment of the CAR-T cell population in the patient’s body, in turn offering potential insights into therapy effectiveness and what future treatment options may be advisable.
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Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.
CDMOs announced expansions, exhibitors showcased automated equipment, and supply chain strategy discussions were a focus at CPHI Milan 2026.
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