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Expert perspectives focused on the latest bioanalytical topic & trends

BioAgilytix Team Q&A: Meet Nikhil Soni

Tell us a little about your background and how you came to join BioAgilytix. Some of my friends at my previous job joined BAL and told me about how much they liked it here. What is your current role, and how has it evolved since joining the team? Scientist III/BPM. Since joining the team I’ve

DNA splicing genetic engineering

CMC Requirements for Cell and Gene Therapy for IND Applications

The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene therapies. The focus of the guidance is on SISPQ (safety, identity, strength, purity and quality), critical quality attributes (CQAs) and risk assessment. These apply to new cell/gene therapy products that

FDA RACE for Children Act: What You Should Know

Short for Research to Accelerate Cures and Equity, the RACE Act went into effect on August 18, 2020, and significantly increased the number of required studies devoted to pediatric cancer research, drugs, and therapies. Originally enacted in August 2017, as a part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), the RACE Act

outsourcing rd processes to cro

The Benefits of Outsourcing R&D Processes to CROs

As a leading contract research organization (CRO), BioAgilytix helps companies around the world with research and development, leveraging expertise in cell-based assays, immunogenicity, biomarkers and pharmacokinetics. We perform assay development and validation as well as sample analysis, lot release testing and ongoing data surveillance after drug products are introduced to market. Committed to helping reduce

Male nurse administering shot to old female patient

Noninvasive Liquid Biopsy Assays Integrating Tumor and Immune Biomarkers Prove to Be Promising Tools in Immuno-Oncology

Tumor tissue biopsies have been the traditional method of identifying and analyzing cancer cells. But in addition to being invasive and risky, they have many limitations. Tumor accessibility is often problematic as are issues with monitoring the progression of disease. Tissue samples from a single location don’t always provide a full picture of a tumor’s

|Researchers viewing biosamples

The Benefits of Hiring the Right CRO

Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract basis. Contract Research Organizations are hired to offer research support and conduct clinical trials to safely and efficiently bring life-saving drugs and vaccines to market. Lasting partnerships between CROs and

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