PharmaCyte Biotech Inc (PMCB): GMP Production of an Encapsulated Cell T...

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Re: ferenc post# 75730

Tuesday, 10/10/2017 8:03:20 PM

Tuesday, October 10, 2017 8:03:20 PM

GMP Production of an Encapsulated Cell Therapy Product: Issues and Considerations.

Explanations of why pmcb FAILED by BRIAN SALMONS*, OLIVER HAUSER, WALTER H. GU¨NZBURG and WALTER TABOTTA

One of the major concerns facing relatively young biotechnology compa- nies once a lead prod- uct has been identified is the issue of manufacturing. Usually this involves the upscaling of a lab-scale pro- cess while at the same time, complying with good manufacturing practice (GMP) to ensure a reproducibly- produced and consistent product. It also involves the establishment of specific and robust assays in process controls and release criteria.

https://www.researchgate.net/profile/Brian_Salmons/publication/236165642_GMP_Production_of_an_Encapsulated_Cell_Therapy_Product_Issues_and_Considerations/links/02e7e516bda4925bf0000000/GMP-Production-of-an-Encapsulated-Cell-Therapy-Product-Issues-and-Considerations.pdf

Disclosure: I am involved in and support the SEC whistleblower program, I may be rewarded cash for information that leads to the successful enforcement by the SEC of a federal court or administrative action of 1m+.