Assay Development for Immunogenicity Testing of Therapeutic Proteins
DRAFT GUIDANCE
This guidance document is being distributed for comment purpos only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact (CDER) Susan Kirshner at 301-827-1731, or (CBER) Office of Communication, Outreach, and Development at 301-827-1800.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
Center for Biologics Evaluation and Rearch (CBER)
December 2009
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Assay Development for Immunogenicity Testing of Therapeutic Proteins
Additional copies are available from:
Office of Communication
Division of Drug Information, WO51, Room 2201
Center for Drug Evaluation and Rearch
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
(Tel) 301-796-3400; (Fax) 301-847-8714
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Office of Communication, Outreach, and
Development, HFM-40
Center for Biologics Evaluation and Rearch
Food and Drug Administration
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v/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
(Tel) 800-835-4709 or 301-827-1800
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
Center for Biologics Evaluation and Rearch (CBER)
December 2009
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TABLE OF CONTENTS
I.
< .1.33.3.4.4.4.4.6.7.7.7.7.8.9.9.9.910.10.10.10.10.10.11.11.11.11.12.12II. DISCUSSION.. (1)
A. General (1)
B. Immunogenicity Testing During Product Development (2)
C. Principles of Immunogenicity Testing During Product Development (2)
III. APPROACH TO
A. Overview of
1.
2. Aspects of
B.
1. Selection
2. Selection of Assay
3. Interference
4. Defining a .
C.
1. Selection
2.
3.
4. Confirmation of
5. Cut Point of Neutralizing
6. Multiple
IV. CLINICAL ASPECTS OF .
A. Critical Considerations
B. Determining the .
1. .
恭维2.
3.
C. Assay
1.
2.
cci是什么意思3.
V.
A. Validation of Screening Assay .............................................................................................
1. Sensitivity ...........................................................................................................................
.12.13.13.14.14.14.14.14.15.1515.16.16.17.17.17.17.17.18.18.18.18.18.192.
3.
4. Robustness and
B. Validation of
1. Sensitivity ..........................................................................................................................
2.
营养师报考条件2020最新规定3.
4. Other Elements of Neutralizing
C. Validation of Immunodepletion/Competitive
VI. IMPLEMENTATION OF
A. Obtaining .
B. Concurrent Positive and Negative .
C. Cut
D. Reporting
E.
F.
1.
2.
3.
4. High Levels of Endogenous Protein
VII. OTHER ASPECTS OF IMMUNOGENICITY TESTING ..........................................
A.
B.
VIII.
Guidance for Industry1 1
2 3 4 5
Assay Development for Immunogenicity Testing
of Therapeutic Proteins
This draft guidance, when finalized, will reprent the Food and Drug Administration’s (FDA’s) current
6
7 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to
8 bind FDA or the public. You can u an alternative approach if the approach satisfies the requirements of
9 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
10 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call
the appropriate number listed on the title page of this guidance.
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体会英文37
38 I. INTRODUCTION
This guidance provides recommendations to facilitate industry’s development of immune assays for asssment of the immunogenicity of therapeutic proteins during clinical trials.2 This document includes guidance for binding assays, neutralizing assays, and confirmatory assays. While the document does not specifically discuss the development of immune assays for animal studies, the concepts discusd are relevant to the qualification and validation of immune studies for preclinical evaluation of data.
This document does not discuss the product and patient risk factors that may contribute to immune respon rates (immunogenicity).mbs
In addition, this document does not specifically discuss how results obtained from immunoassays relate to follow-on biologic therapeutic proteins. However, elements of assay validation may affect comparability determinations of immune respons. FDA guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The u of the word should in Agency guidances means that something is suggested or recommended, but not required.
英语六级成绩单II. DISCUSSION
A. General
1 This guidance has been prepared by the Office Biotechnology Products in the Office of Pharmaceutical Science, Center for Drug Evaluation and Rearch (CDER) and the Center for Biologics Evaluation and Rearch (CBER) at the Food and Drug Administration.
smartcard reader2 This guidance does not pertain to immunogenicity assays for asssment of immune respon to preventative and therapeutic vaccines for infectious dia indications.
