NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

there have been multiple references by Fraunhofer over the years to utilizing an "optimized" L product.

I agree!

The manufacturing process for the immunotherapeutic DCVax®-L has been optimized and implemented as part of a clinical trial conducted by American biotech company Northwest Biotherapeutics, Inc. The therapeutic approach is based on autologous dendritic cells and aims to improve the treatment of glioblastoma, a particularly aggressive type of brain tumor.
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/AnnualReport_IZI_2017_short.pdf

Dog logic,

The recent European Union marketing authorization of Zynteglo (lentiglobin) is an interesting case. During the clinical studies of Zynteglo, the drug manufacturing process was changed and optimized.

During the clinical studies, the drug manufacturing process was changed and optimized. At the time of approval, only three patients with the ß0/ß0 genotype had been treated with product manufactured by the commercial process. A comparability exercise between the previous process used for clinical trial material and the commercial manufacturing processes at the quality level had been extensively discussed before the evaluation. Given the well-known sensitivity of gene therapies to changes in the manufacturing process, and resulting uncertainties regarding their impact on drug product potency and clinical outcome, these changes might have contributed to a negative regulatory decision. However, in this particular case, pharmacodynamic parameters and efficacy results were consistent across studies. To address these uncertainties, the Agency decided to impose the following obligations: (i) tight control of the finished product potency attributes and (ii) reevaluation of the acceptance criteria for attributes related to the drug product potency tests using batch release data and clinical results after 6 months follow-up of 20 patients treated with commercial batches. It is up to the company to resolve the issues speedily and launch the product.
https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.1639?af=R