Potency assay development uses DoE and QbD to improve accuracy, consistency, and regulatory readiness in biologics testing.

Gene editing has emerged as a powerful approach for targeting the genetic causes of disease, but getting the editing ...

Avance Biosciences opened its new Potency and Cell-Based Assay Center of Excellence, a purpose-built facility designed to expand and centralize the company’s capabilities in potency and functional ...

Abzena, a CDMO, said it has expanded its early- and late-phase analytical capabilities to now include GMP cell-based potency assays at their Cambridge, U.K., and San Diego, CA, development and ...

Thepatent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, ...

–Publication highlights Deramiocel’s anti-fibrotic activity and describes a validated potency assay supporting quality control and product consistency in late-stage development– The publication, ...

MSCs improve therapeutic consistency and precision across cell therapies. The approach also supports scalable allogeneic ...

CHICAGO — For patients with advanced heart failure, an injection of autologous mononuclear cells into damaged myocardia missed the primary endpoint in the sham-controlled, randomized, blinded CardiAMP ...

ENA101 is designed to selectively recognize the DARKFOX‑A3 peptide presented by HLA‑A*03:01, a highly prevalent HLA allele, ...