The State Of The Biosimilars Market
3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a significant number of top-selling drugs…
How Have Advanced Drug Modalities Impacted Bioanalysis?
...of drug types that are continually evolving and providing room for improvement in bioanalysis. References: https://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data#EAI https://embioagilytix.wpengine.com/wp-content/uploads/2022/05/AAPS-Journal_Amanda-Hayes-Article_May-2022.pdf Partner With BioAgilytix BioAgilytix is a leading…
Neoantigens Revive Vaccine Opportunities in Immuno-Oncology
Neoantigens are novel proteins that form on cancer cells following the development of mutations in the tumor-cell DNA. These proteins are new to the immune…
Multiplexed Cytokine Analysis in Drug Development
Cytokines are proteins released by activated cells that serve as soluble messengers binding to target cells through surface receptors, signaling functional responses. The nature of…
Determining Immunogenicity for CAR-T cell Therapies
Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T cells against cancer cells. CAR-T…
The Importance Of GMP Certification In Drug Development
Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure the safety of the end…
Is ISR Needed For Biomarker Assays?
Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated studies. ISR was established in…
Genetic Screening and Big Data’s Influence on Drug Production and Biomarker Identification
The Human Genome Project (HGP) was largely successful in its goal to identify the genetic blueprint of life. The scientific community has begun to translate…
Strategies To Overcome Bioanalytical Challenges
Strategies to overcome bioanalytical challenges in Cell & Gene Therapies development With advancements in molecular and cellular engineering techniques, the number of cell and gene…
Are We Closer to Using the Word “Cures” More Often?
As we look towards the development of the next generation of drugs and therapies, it starts to beg the question of whether we are creating…