Notice2023-04267
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry; Availability
Primary source
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Published
March 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens.'' The purpose of this draft guidance is to provide to sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of infection. A critical quality control measure for these products is the development and implementation of a potency assay(s) adequate to ensure that each lot is produced consistently with the potency necessary to achieve clinical efficacy and that such potency is maintained over the shelf life of the product. This draft guidance provides detailed recommendations to drug developers with the goal of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product's life cycle.
Full Text
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<title>Federal Register, Volume 88 Issue 41 (Thursday, March 2, 2023)</title>
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<body><pre>[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13126-13128]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04267]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0202]
Potency Assay Considerations for Monoclonal Antibodies and Other
Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 13127]]
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Potency
Assay Considerations for Monoclonal Antibodies and Other Therapeutic
Proteins Targeting Viral Pathogens.'' The purpose of this draft
guidance is to provide to sponsors recommendations that assist in the
development of monoclonal antibodies (mAbs) and other therapeutic
proteins that directly target viral proteins or host cell proteins
mediating pathogenic mechanisms of infection. A critical quality
control measure for these products is the development and
implementation of a potency assay(s) adequate to ensure that each lot
is produced consistently with the potency necessary to achieve clinical
efficacy and that such potency is maintained over the shelf life of the
product. This draft guidance provides detailed recommendations to drug
developers with the goal of helping to ensure that drug developers
provide adequate information to assess potency at each stage of a
product's life cycle.
DATES: Submit either electronic or written comments on the draft
guidance by May 1, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-0202 for ``Potency Assay Considerations for Monoclonal
Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Natalia Comella, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 301-
796-6226.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Potency Assay Considerations for Monoclonal Antibodies and
Other Therapeutic Proteins Targeting Viral Pathogens.'' The purpose of
this draft guidance is to provide to sponsors recommendations that
assist in the development of mAbs and other therapeutic proteins that
directly target viral proteins or host cell proteins mediating
pathogenic mechanisms of infection. A critical quality control measure
for these products is the development and implementation of a potency
assay(s) adequate to ensure that each lot is produced consistently with
the potency necessary to achieve clinical efficacy and that such
potency is maintained over the shelf life of the product. This draft
guidance provides detailed recommendations to drug developers with the
goal of helping to ensure that drug developers provide adequate
information to assess potency at each stage of a product's life cycle.
This draft guidance applies only to mAbs and other therapeutic
proteins regulated by the Center for Drug Evaluation and Research that
are designed to bind to viral proteins or their receptors on host
cells, inhibit
[[Page 13128]]
viral entry, and/or elicit Fc-mediated effector function and are
subject to licensure under section 351(a) or section 351(k) of the
Public Health Service Act (PHS Act) (42 U.S.C. 262(a) or (k)). This
draft guidance does not apply to immunomodulatory drugs (e.g.,
cytokines or cytokine antagonists), vaccines, hyperimmune globulins,
gene therapies, cell therapies, and convalescent plasma.
The draft guidance describes approaches that sponsors should use to
develop potency assay methods for release and stability that assess
comprehensively known or potential mechanism(s) of action of the
product. The sensitivity of these methods must be established, for
example, to conduct the appropriate laboratory determination of
satisfactory conformance to final specifications for the drug product
(i.e., demonstrate lot-to-lot consistency). In addition to release and
stability methods, other methods that demonstrate the biological
function(s) of the product may be needed for characterization and
comparability studies. The draft guidance describes methods that
sponsors should use to ensure the potency of mAbs and other therapeutic
proteins proposed to prevent or treat a viral infection.
In January 2021, FDA published the guidance for industry entitled
``COVID-19: Potency Assay Considerations for Monoclonal Antibodies and
Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity''
(available at <a href="https://www.fda.gov/media/145128/download">https://www.fda.gov/media/145128/download</a>) to support
public health efforts following a declaration, under section 319 of the
PHS Act (42 U.S.C. 247d), by the Secretary of Health and Human Services
of a public health emergency related to Coronavirus Disease 2019 (the
disease caused by SARS-CoV-2) (section 319 public health emergency).
The 2021 guidance focuses solely on addressing potency assays as they
relate to mAbs and other therapeutic proteins that directly target
SARS-CoV-2, and it is intended to remain in effect only for the
duration of the section 319 public health emergency related to
Coronavirus Disease 2019. However, FDA believes that many of the
recommendations set forth in the 2021 guidance are applicable outside
the context of the section 319 public health emergency and are
applicable to mAbs and other therapeutic proteins directly targeting
any viral surface (glyco)proteins mediating pathogenic mechanisms of
infection, not just those that directly target SARS-CoV-2. FDA is,
therefore, issuing this draft guidance. In preparing this guidance, FDA
considered comments received regarding the 2021 guidance as well as the
Agency's experience with SARS-CoV-2 and other viruses.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Potency
Assay Considerations for Monoclonal Antibodies and Other Therapeutic
Proteins Targeting Viral Pathogens.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 for submission of an investigational
new drug application have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 for new drug
applications have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR parts 601 and 610 pertaining to
biologics license applications have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR parts 210
and 211 pertaining to current good manufacturing practices have been
approved under OMB control number 0910-0139. The collections of
information in 21 CFR part 11 pertaining to electronic records and
signatures have been approved under OMB control number 0910-0303.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: February 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04267 Filed 3-1-23; 8:45 am]
BILLING CODE 4164-01-P
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