作者: 乳汁 時(shí)間: 2025-3-21 20:45 作者: 不知疲倦 時(shí)間: 2025-3-22 04:03 作者: Angioplasty 時(shí)間: 2025-3-22 04:35
- Molecular and Cellular Therapeutics (MCT)nical trials. Careful planning is required when designing a new or modifying an existing facility to maintain compliance with good manufacturing practice/good tissue practice (GMP/GTP) regulations. Likewise, considerable forethought is essential to meet current and anticipate future manufacturing re作者: 執(zhí) 時(shí)間: 2025-3-22 12:02 作者: Jingoism 時(shí)間: 2025-3-22 16:38
Center for Cell and Gene Therapy (CAGT)n 2008, prepares viral vectors for use in gene therapy. The second, purpose-built into existing space was opened in 1998 and manufactures cellular products for hematopoietic transplantation, immunotherapy and regenerative medicine. Together the facilities prepare approximately 3,000 products and int作者: Jingoism 時(shí)間: 2025-3-22 20:29
Design of a New GMP Facility - Lessons Learned0 the facility will be relocated from the 11th to the 16th floor of the Feigin Center at Texas Children’s Hospital (TCH). This floor is a new addition to the building which is being expanded from 12 to 20 stories (Figs. 7.1a and b). This has given us the opportunity to redesign the space based on ou作者: 貪婪的人 時(shí)間: 2025-3-22 22:46 作者: Atheroma 時(shí)間: 2025-3-23 02:34
Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy oietic cell transplantation (HCT) through its program of professional standards and voluntary accreditation for the procurement, processing, and transplantation of hematopoietic cell products. This chapter describes the FACT Standards and Inspection and Accreditation Program.作者: excursion 時(shí)間: 2025-3-23 07:20 作者: 專(zhuān)橫 時(shí)間: 2025-3-23 10:51 作者: 多產(chǎn)魚(yú) 時(shí)間: 2025-3-23 16:59
Cleaning Proceduresres the development and implementation appropriate and effective methods for cleaning, procedures to monitor if these methods are indeed effective, and documentation of cleaning procedures on an ongoing basis. This chapter discusses various approaches that can be used to fulfill these requirements i作者: objection 時(shí)間: 2025-3-23 18:13 作者: 軍械庫(kù) 時(shí)間: 2025-3-23 23:48
Supply Managementand cellular therapy products. In addition, a controlled and auditable procedure for the management of supplies and reagents is essential to provide traceability, and to ensure that products are manufactured using safe and appropriate components. This chapter describes procedures for developing and 作者: 食草 時(shí)間: 2025-3-24 06:15 作者: 老人病學(xué) 時(shí)間: 2025-3-24 07:03
https://doi.org/10.1007/b102110cancer; cell; gene; gene therapy; genes; regulation; research; stem cell; tissue作者: 有法律效應(yīng) 時(shí)間: 2025-3-24 12:53 作者: 使絕緣 時(shí)間: 2025-3-24 17:20 作者: Lymphocyte 時(shí)間: 2025-3-24 20:01
Cleaning Proceduresres the development and implementation appropriate and effective methods for cleaning, procedures to monitor if these methods are indeed effective, and documentation of cleaning procedures on an ongoing basis. This chapter discusses various approaches that can be used to fulfill these requirements in different types of cell processing facilities.作者: Blazon 時(shí)間: 2025-3-25 02:49
Supply Managementand cellular therapy products. In addition, a controlled and auditable procedure for the management of supplies and reagents is essential to provide traceability, and to ensure that products are manufactured using safe and appropriate components. This chapter describes procedures for developing and implementing a supply management system.作者: 跳脫衣舞的人 時(shí)間: 2025-3-25 05:34
Klaus-Jochen Engel,Rainer Nagelld continue. As the field of cell therapy has advanced, and products are moving toward licensure, the regulation of these products has become increasingly complicated. The general principles involved in filing and maintaining an Investigational New Drug (IND) and interacting with the Food and Drug A作者: indecipherable 時(shí)間: 2025-3-25 11:21 作者: 影響深遠(yuǎn) 時(shí)間: 2025-3-25 14:15
Klaus-Jochen Engel,Rainer Nagelc Goods Act 1989. Health care policy in Australia is the collective responsibility of the governments of the Australian federation. In 2002, the federation directed the TGA to develop a suitable regulatory model for human cell, tissue, and emerging biological therapies. As the process for developing作者: SNEER 時(shí)間: 2025-3-25 16:01
A Brief History of the Exponential Function,nical trials. Careful planning is required when designing a new or modifying an existing facility to maintain compliance with good manufacturing practice/good tissue practice (GMP/GTP) regulations. Likewise, considerable forethought is essential to meet current and anticipate future manufacturing re作者: gusher 時(shí)間: 2025-3-25 21:22 作者: Infraction 時(shí)間: 2025-3-26 02:32 作者: 剝皮 時(shí)間: 2025-3-26 06:44 作者: 傀儡 時(shí)間: 2025-3-26 09:10
e subsequently expanded to cover the field of cellular therapies. This chapter will provide a brief history of blood banking and transfusion practices and the events leading up to the need to regulate these activities. It will also explore how the quality management system approach to regulatory com作者: groggy 時(shí)間: 2025-3-26 16:07
oietic cell transplantation (HCT) through its program of professional standards and voluntary accreditation for the procurement, processing, and transplantation of hematopoietic cell products. This chapter describes the FACT Standards and Inspection and Accreditation Program.作者: inchoate 時(shí)間: 2025-3-26 17:35 作者: 災(zāi)難 時(shí)間: 2025-3-27 00:14 作者: Spirometry 時(shí)間: 2025-3-27 03:52 作者: Fortify 時(shí)間: 2025-3-27 07:49
Valen E. Johnson,James H. Albertn unclassified laboratory space or in a Class 10,000 cleanroom. Classification of space will, however, necessitate that there is documentation to verify that the specific classification is maintained on an ongoing basis. In facilities that are unclassified, the aim of the environmental monitoring pr作者: 兒童 時(shí)間: 2025-3-27 12:43 作者: Neutral-Spine 時(shí)間: 2025-3-27 16:08 作者: 骨 時(shí)間: 2025-3-27 20:18
Facility EquipmentControl of laboratory equipment is critical in a cGMP facility. Equipment management ensures compliance with all regulations and standards and documents the lifecycle of the equipment, encompassing product selection, installation, validation, maintenance and disposal.作者: Gossamer 時(shí)間: 2025-3-28 00:22 作者: 拍下盜公款 時(shí)間: 2025-3-28 06:07 作者: DAUNT 時(shí)間: 2025-3-28 07:03 作者: OGLE 時(shí)間: 2025-3-28 12:52 作者: 按時(shí)間順序 時(shí)間: 2025-3-28 15:50 作者: jovial 時(shí)間: 2025-3-28 21:10 作者: 密切關(guān)系 時(shí)間: 2025-3-29 00:10 作者: Eulogy 時(shí)間: 2025-3-29 05:23 作者: fastness 時(shí)間: 2025-3-29 10:52 作者: CAMEO 時(shí)間: 2025-3-29 15:02
Maritta Heisel,Jeanine Souquières to the building which is being expanded from 12 to 20 stories (Figs. 7.1a and b). This has given us the opportunity to redesign the space based on our experience working in the present facility. This chapter describes what changes have been made based on lessons learned from working in the previous facility for nearly 10 years.作者: BROOK 時(shí)間: 2025-3-29 18:58 作者: Comprise 時(shí)間: 2025-3-29 22:13
or tenet of GMP/GTP is “if an activity was not documented, it was not done.” Both quality oversight and documentation are largely facilitated by use of Standard Operating Procedures (SOPs). This chapter reviews the structure and development of SOPs.作者: 內(nèi)部 時(shí)間: 2025-3-30 03:39 作者: Acetaldehyde 時(shí)間: 2025-3-30 04:03
- Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Labot and manufacturing of biological products required for University investigator-initiated research protocols, external partnerships, and contracts for cellular product manufacturing. This chapter describes the design features of these two laboratories.作者: 貪婪的人 時(shí)間: 2025-3-30 12:06 作者: harpsichord 時(shí)間: 2025-3-30 15:09 作者: 和諧 時(shí)間: 2025-3-30 20:35
AABB Cell Therapy Standards and the events leading up to the need to regulate these activities. It will also explore how the quality management system approach to regulatory compliance has been applied to the development of the AABB cell therapy standards and accreditation program.作者: 知道 時(shí)間: 2025-3-30 20:45
Standard Operating Proceduresor tenet of GMP/GTP is “if an activity was not documented, it was not done.” Both quality oversight and documentation are largely facilitated by use of Standard Operating Procedures (SOPs). This chapter reviews the structure and development of SOPs.
