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2nd International Conference and Exhibition on 9 I$ G7 Z; E) A' gCell & Gene Therapy October 23-25, 2013 Holiday Inn Orlando International Airport, Orlando, FL, US ) L2 J: a, V. _Cell content and viability assessments for human cell therapy products: Towards effective 8 f" P0 o& V/ r" y
development of suitable assays and controls 7 ]0 K' C$ d3 p, @. EBrent L. Atkinson) \0 H) W6 r0 u! N
Atkinson Biologics Consulting, USA# J' R& X6 K+ K( g# M8 K
Comprehensive and robust manufacturing controls are crucial in the development of commercially successful advanced 4 @" k$ c2 n$ F2 k: M( V
cellular therapy products (CTP). Te Alliance for Regenerative Medicine (ARM) and the International Society for Cell . F7 Z m" y! Y' J4 h/ n
Terapy (ISCT) are undertaking a joint project to examine analytical methods for product quality and consistency in CTP ! i2 m0 _* C. idevelopment. Tis group has identifed cell content (quantity) and cell viability as two fundamental and universal measurements 3 |4 o/ s2 M s/ e
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 8 K) B; r8 C4 Y9 _- sguide developers through the cell therapy product development process and to establish confdence through assay qualifcation ; u. a( a2 R& w: n2 b
and validation. Tis collaboration is an initial efort to address FDA requests to help establish appropriate controls during product ' l5 Q/ n" c- D# Z3 f: z ^development.2 a7 y2 C, `" S3 p" o, X8 ]1 i
Tis presentation will describe the need and current status of analytical methods that can help ensure consistency and 1 m0 g9 o9 G! n- I3 {) @$ G$ P* i7 j9 U
comparability for cell content and viability specifcations. Consideration of the selection and qualifcation of these assays are 2 b% ?9 |/ H% c+ T6 I6 E
important considerations early in the development process and can be used in conjunction with purity and potency assays since a % c5 i* K1 s! b1 |: C9 ]single method may not adequately cover the spectrum of characterization that is needed to ensure a quality product. An overview + C$ G3 Y$ p9 ?9 ]
of US, EU and ICH guidance with respect to content and viability assessments of CTP will also be discussed. Incorporation of 0 i' A+ P* I$ T2 T/ N2 x/ I7 L
these assays is an important part of an adequate and robust control strategy, which better ensures that a safe and potent product 0 B* S) {0 I% Y
will be consistently manufactured. , F5 t7 n# C0 D1 Zatkinsonbrent520@gmail.com) Q. |; i& a2 x" O# b
Biography 2 s% U% h8 Q/ [- P- HBrent L. Atkinson, Ph.D. has held Vice President and Director level positions at small, mid, and large medical companies where he has developed 2 N+ P j* [. K9 W3 h
and commercialized cellular therapeutics and biomaterials for orthobiologic applications. Responsibilities have included leadership of preclinical 7 D( C+ H! v. Y; u( s S5 y
and clinical studies, planning and submission of regulatory flings, direction of manufacturing, and management of the intellectual property portfolio. ! m* D v9 ^0 I4 bHe has authored over 30 publications, is an inventor on eight issued patents and holds a Doctorate in Molecular Biology from Columbia University. 5 [5 |2 r( i7 ?0 [Atkinson Biologics specializes in translating cellular therapeutic products from conception through development and ultimately to commercialization.作者: 18943340581 时间: 2014-1-23 08:49
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