06.20.26 -- FDA Codifies CMC Flexibility For CGTs, Assay Selection, And Comparing Analytical-Validation Guidelines

Hello and Happy Saturday! This weekend’s editorial focus is on CMC, specifically as it relates to CGT products.

This guest column with Arnold & Porter’s Abeba Habtemariam and Jonathan Trinh explores the nuance of the FDA’s recent guidance outlining how it will apply CMC flexibility to CGT products heading toward a BLA. This guidance essentially formalizes what’s already been in practice at the agency, acknowledging the unique nature of CGTs and their development.

Demonstrating product quality and safety is paramount in any product’s CMC package, and this is especially true for novel CGTs. In this segment from last month’s Bioprocess Online Live, our panelists talked about defining quality and how product type influences assay selection.

Assay validation can look different depending on which agency’s guidelines you follow. This is examined in a guest column from Bilel Khedir, Pharm.D., which compares analytical-validation guidelines from six major regulatory agencies to identify which were most efficient in terms of sponsor effort and regulatory burden.

Before you go, be sure to check out some selected content from our partners below!

Tyler Menichiello                            
Chief Editor, Bioprocess Online

Agilent explores how precise DNA quality assessment strengthens long-read sequencing outcomes, helping teams choose the right approach to ensure confident genomic data.

Ecolab reveals how advancing purification strategies can keep pace with complex biotherapeutics, helping teams overcome bottlenecks and extend resin performance.

LICORbio details a streamlined approach to achieving cleaner Western blot results, with practical guidance on reducing background and improving detection accuracy.

Simtra identifies failure points and sharpens lyophilization efficiency to help teams optimize drying parameters, protect product integrity, and accelerate scale-up.

Medac CMDO is redefining labs to drive faster decisions, smoother tech transfers, and consistent data—helping complex therapies reach patients with confidence.

PHC empowers biopharma teams with real-time metabolic monitoring to reduce variability, improve yields, and accelerate development.

Tecan’s precise, time-resolved monitoring of cell health can distinguish apoptotic and necrotic events, helping researchers better interpret compound effects.