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& o5 }7 u$ n- T5 v5 u+ A2nd International Conference and Exhibition on: b6 u9 I$ d% w3 b
Cell & Gene Therapy October 23-25, 2013 Holiday Inn Orlando International Airport, Orlando, FL, US
! ~. Y' z7 K W, P! c/ pCell content and viability assessments for human cell therapy products: Towards effective
. o9 y- M- A0 M% s' sdevelopment of suitable assays and controls; c6 z2 G$ n! }8 s7 r" T" `0 g
Brent L. Atkinson
& \0 X* y7 Y. [/ v$ EAtkinson Biologics Consulting, USA8 V/ o0 J4 P1 T6 I- V
Comprehensive and robust manufacturing controls are crucial in the development of commercially successful advanced ' i; _: j b9 O( y
cellular therapy products (CTP). Te Alliance for Regenerative Medicine (ARM) and the International Society for Cell
6 |! v& G* B( F+ K) j8 n3 J2 aTerapy (ISCT) are undertaking a joint project to examine analytical methods for product quality and consistency in CTP
9 l* B% f* I. C4 wdevelopment. Tis group has identifed cell content (quantity) and cell viability as two fundamental and universal measurements
7 Q9 [0 X6 X8 y: Y* u8 athat will be used by developers to defne total and viable/non-viable cell content for any CTP. Te project will create a roadmap to - a7 J" r2 ~+ U* a
guide developers through the cell therapy product development process and to establish confdence through assay qualifcation 6 f* V! o/ b% @& q2 t4 s' }# F
and validation. Tis collaboration is an initial efort to address FDA requests to help establish appropriate controls during product ' h6 c4 N; \7 R# `3 T# ?+ d: S
development.% x6 f1 X9 T5 O! b+ g( K5 {
Tis presentation will describe the need and current status of analytical methods that can help ensure consistency and
" K5 z0 J- h2 m% {* D! Kcomparability for cell content and viability specifcations. Consideration of the selection and qualifcation of these assays are
, j; V/ l2 S- {" A9 P9 ]& simportant considerations early in the development process and can be used in conjunction with purity and potency assays since a
8 [& v$ p: r- S/ ~- G! d' d! Csingle method may not adequately cover the spectrum of characterization that is needed to ensure a quality product. An overview $ g4 [9 G$ Q: [' B" ^
of US, EU and ICH guidance with respect to content and viability assessments of CTP will also be discussed. Incorporation of 2 ^' r6 S4 }) M9 m8 b) a0 j( a) K
these assays is an important part of an adequate and robust control strategy, which better ensures that a safe and potent product
+ S9 h" w' T5 G/ v" `will be consistently manufactured.0 @8 ^# B4 s h1 v
atkinsonbrent520@gmail.com
+ W0 {5 n; d' [1 l5 T. s @8 `Biography3 }2 D% R- U4 ` v' E
Brent L. Atkinson, Ph.D. has held Vice President and Director level positions at small, mid, and large medical companies where he has developed 3 _4 E# m8 |1 ~' U4 ?/ V4 Z
and commercialized cellular therapeutics and biomaterials for orthobiologic applications. Responsibilities have included leadership of preclinical 2 [) ^" D6 N. Y. y, a/ J8 D1 c% P, v
and clinical studies, planning and submission of regulatory flings, direction of manufacturing, and management of the intellectual property portfolio.
1 ~; z' ^( \: g+ K' L: d& L5 CHe has authored over 30 publications, is an inventor on eight issued patents and holds a Doctorate in Molecular Biology from Columbia University. ! @5 E% Q; |# J* X, X" t
Atkinson Biologics specializes in translating cellular therapeutic products from conception through development and ultimately to commercialization. |
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发表于 2013-12-5 11:15
