-
2
-
-
1642591796
-
FDA's proposed regulatory approach to regulation of hematopoietic stem/progenitor cell products
-
Harvath L. FDA's proposed regulatory approach to regulation of hematopoietic stem/progenitor cell products. Cytotherapy 1999;1:358-9.
-
(1999)
Cytotherapy
, vol.1
, pp. 358-359
-
-
Harvath, L.1
-
4
-
-
0029553210
-
Current good manufacturing practices
-
Zuck TF. Current good manufacturing practices. Transfusion 1995;35:955-66.
-
(1995)
Transfusion
, vol.35
, pp. 955-966
-
-
Zuck, T.F.1
-
5
-
-
0030665804
-
Big biotech: Designing the plant of the future
-
Williams RL. Big biotech: designing the plant of the future. BioPharm 1997;11:44-51.
-
(1997)
BioPharm
, vol.11
, pp. 44-51
-
-
Williams, R.L.1
-
6
-
-
14744301271
-
Multiuse biopharmaceutical manufacturing
-
Hamers MN. Multiuse biopharmaceutical manufacturing. Bio/Technology 1993;11:561-70.
-
(1993)
Bio/Technology
, vol.11
, pp. 561-570
-
-
Hamers, M.N.1
-
7
-
-
1642638455
-
Building quality into GMP facilities
-
Odum JN. Building quality into GMP facilities. BioPharm 1993;6:42-52.
-
(1993)
BioPharm
, vol.6
, pp. 42-52
-
-
Odum, J.N.1
-
8
-
-
1642622910
-
Multiuse manufacturing facilities for biologicals
-
Bader FG, Blum A, Garfinkle BD, et al. Multiuse manufacturing facilities for biologicals. BioPharm 1992;6:32-40.
-
(1992)
BioPharm
, vol.6
, pp. 32-40
-
-
Bader, F.G.1
Blum, A.2
Garfinkle, B.D.3
-
9
-
-
0013628490
-
1989. Biotechnology facility requirements, Part I: Facility and systems design
-
Hill D, Beatrice M. 1989. Biotechnology facility requirements, Part I: Facility and systems design. BioPharm 1989;10:20-6.
-
(1989)
BioPharm
, vol.10
, pp. 20-26
-
-
Hill, D.1
Beatrice, M.2
-
10
-
-
0029163480
-
Concept and organization of a clinical gene therapy lab
-
Kittler EL, Quesenberry PJ. Concept and organization of a clinical gene therapy lab. J Cell Biochem 1995;58:403-9.
-
(1995)
J Cell Biochem
, vol.58
, pp. 403-409
-
-
Kittler, E.L.1
Quesenberry, P.J.2
-
12
-
-
0031419683
-
An academic centre for gene therapy research with clinical grade manufacturing capability
-
Islam KB, Blomberg P, Wikstrom K, Smith CI. An academic centre for gene therapy research with clinical grade manufacturing capability. Ann Med 1997;29:579-83.
-
(1997)
Ann Med
, vol.29
, pp. 579-583
-
-
Islam, K.B.1
Blomberg, P.2
Wikstrom, K.3
Smith, C.I.4
-
13
-
-
84879115766
-
-
July 11. The Division of Cellular and Gene Therapies HFM-518 Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD20852, USA
-
FDA Forum 1996 on Gene Therapy: Development and Evaluation of Phase I Products, Vector Development. July 11, 1996. The Division of Cellular and Gene Therapies HFM-518 Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD20852, USA.
-
(1996)
FDA Forum 1996 on Gene Therapy: Development and Evaluation of Phase I Products, Vector Development
-
-
-
14
-
-
0000153375
-
Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals
-
Docket No. 95N-0362
-
Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals. Docket No. 95N-0362. Fed Reg 1996;61(87):20104-15.
-
(1996)
Fed Reg
, vol.61
, Issue.87
, pp. 20104-20115
-
-
-
15
-
-
0037886583
-
-
center for devices and radiologic health. January 1
-
Medical device quality systems manual, center for devices and radiologic health. January 1, 1997. http://www.fda.gov /cdrh/qsr/contnt.html
-
(1997)
Medical Device Quality Systems Manual
-
-
-
19
-
-
0031178501
-
Setting alert/action limits for environmental monitoring programs
-
Wilson JD. Setting alert/action limits for environmental monitoring programs. PDA J Pharm Sci Technol 1997; 51:161-2.
-
(1997)
PDA J Pharm Sci Technol
, vol.51
, pp. 161-162
-
-
Wilson, J.D.1
-
20
-
-
0031298669
-
In-process testing and limits
-
Sjoholm I. In-process testing and limits. Develop Bio Standard 1997;91:73-8.
-
(1997)
Develop Bio Standard
, vol.91
, pp. 73-78
-
-
Sjoholm, I.1
-
21
-
-
84879097883
-
Microbiological evaluation of clean rooms and other controlled environments
-
general information chapter 1116
-
Microbiological evaluation of clean rooms and other controlled environments. United States Pharmacopoeia, general information chapter 1116. 1995; 1116:1-88.
-
(1995)
United States Pharmacopoeia
, vol.1116
, pp. 1-88
-
-
-
23
-
-
0030817969
-
Moving towards a (microbiological) environmental monitoring programme that can be used to release aseptically produced pharmaceuticals: A hypothesis, a practical programme, and some results
-
Hertroys R, Van Vught PA, Van De Donk HJ. Moving towards a (microbiological) environmental monitoring programme that can be used to release aseptically produced pharmaceuticals: a hypothesis, a practical programme, and some results. PDA J Pharm Sci Technol 1997;51:52-9.
-
(1997)
PDA J Pharm Sci Technol
, vol.51
, pp. 52-59
-
-
Hertroys, R.1
Van Vught, P.A.2
Van De Donk, H.J.3
-
24
-
-
1842384749
-
Environmental monitoring: Regulatory issues
-
Groves MJ, Olson WP, Anisfeld MH, editors. Buffalo Grove, IL: Interpharm Press, Inc.
-
Munson TE, Sorenson RL. Environmental monitoring: regulatory issues. In: Groves MJ, Olson WP, Anisfeld MH, editors. Sterile pharmaceutical manufacturing - applications for the 90's. Buffalo Grove, IL: Interpharm Press, Inc., 1991.
-
(1991)
Sterile Pharmaceutical Manufacturing - Applications for the 90's
-
-
Munson, T.E.1
Sorenson, R.L.2
-
25
-
-
84879096600
-
Hematopoietic cell viability measurement: Trypan blue vs. acridine orange/propidium iodide
-
In press
-
Mascotti K, McCullough J, Burger SR. Hematopoietic cell viability measurement: trypan blue vs. acridine orange/propidium iodide. Transfusion. In press.
-
Transfusion
-
-
Mascotti, K.1
McCullough, J.2
Burger, S.R.3
-
26
-
-
84879088107
-
cGMP cell engineering facility design and environmental monitoring
-
Collins N, Read EJ, Gee A, editors. Oxford: Isis Medical Media, In press
-
Burger SR. cGMP cell engineering facility design and environmental monitoring. In: Collins N, Read EJ, Gee A, editors. Cellular Therapies. Oxford: Isis Medical Media, 2000. In press
-
(2000)
Cellular Therapies
-
-
Burger, S.R.1
|