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全部内容都在这儿：% {2 Y4 e2 h' f; B7 J: u
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2nd International Conference and Exhibition on8 T6 E3 W4 N5 L" @# k
Cell & Gene Therapy October 23-25, 2013 Holiday Inn Orlando International Airport, Orlando, FL, US, o: H, x1 W# |; e
Cell content and viability assessments for human cell therapy products: Towards effective % Z W% O& Q& v7 ^" y9 c9 j% Q: y& R
development of suitable assays and controls, D, l, O6 s5 M( o
Brent L. Atkinson
* d( a. U( |) N" bAtkinson Biologics Consulting, USA
H9 q- i% T$ Q+ |1 I8 KComprehensive and robust manufacturing controls are crucial in the development of commercially successful advanced . F' @( o5 j9 f2 t
cellular therapy products (CTP). Te Alliance for Regenerative Medicine (ARM) and the International Society for Cell
. _: S7 q" M0 a$ I& e6 f v# uTerapy (ISCT) are undertaking a joint project to examine analytical methods for product quality and consistency in CTP
8 B. ?6 x9 B& P* M& E* J5 Kdevelopment. Tis group has identifed cell content (quantity) and cell viability as two fundamental and universal measurements " D' p' G5 Q/ w( A0 e9 [+ Q) Q
that will be used by developers to defne total and viable/non-viable cell content for any CTP. Te project will create a roadmap to
. h! i; Y3 s# e1 l( f7 ]! Nguide developers through the cell therapy product development process and to establish confdence through assay qualifcation
K |; D, k4 h4 yand validation. Tis collaboration is an initial efort to address FDA requests to help establish appropriate controls during product . r$ y2 o$ E' n6 N. q( B
development.
' v* g* w, ~! G! aTis presentation will describe the need and current status of analytical methods that can help ensure consistency and l1 g: q B! Z% m1 \, `
comparability for cell content and viability specifcations. Consideration of the selection and qualifcation of these assays are
: \8 D4 e# M+ j% [important considerations early in the development process and can be used in conjunction with purity and potency assays since a
' @) e, k9 B! o3 k* @! L, Zsingle method may not adequately cover the spectrum of characterization that is needed to ensure a quality product. An overview
" ]# ]1 t8 m" [1 O& C% h* i- i, Iof US, EU and ICH guidance with respect to content and viability assessments of CTP will also be discussed. Incorporation of
: N/ e/ \9 m$ l8 Vthese assays is an important part of an adequate and robust control strategy, which better ensures that a safe and potent product 8 q( U% C! C8 k
will be consistently manufactured.# m. \: O' m% A! S6 Z. L
atkinsonbrent520@gmail.com! r' @7 m7 r4 [& |
Biography8 g% J( f3 h- _
Brent L. Atkinson, Ph.D. has held Vice President and Director level positions at small, mid, and large medical companies where he has developed
, V8 i1 m/ X! `- a+ rand commercialized cellular therapeutics and biomaterials for orthobiologic applications. Responsibilities have included leadership of preclinical
; C$ G& L. p0 g" [and clinical studies, planning and submission of regulatory flings, direction of manufacturing, and management of the intellectual property portfolio. % Y0 }4 W3 y% e* ?/ g! Y
He has authored over 30 publications, is an inventor on eight issued patents and holds a Doctorate in Molecular Biology from Columbia University.
; t ~' |, J F B7 VAtkinson Biologics specializes in translating cellular therapeutic products from conception through development and ultimately to commercialization. |
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发表于 2014-1-22 20:27
