X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    mAbs And Therapeutic Proteins Potency Guidance Issued By FDA

    Novel Purification Means For Protein Drug Manufacturing

    $118bn Sales By 2026 Is What Japanese Pharma Can Expect

    $118bn Sales By 2026 Is What Japanese Pharma Can Expect

    Duchenne Muscular Dystrophy-Cancer Genetic Link Discovered

    Animal Testing Could See An End With An Artificial Model

    Bioavailability Enhancement Market Projects CAGR of 11%

    Hong Kong Gives $500mn Funding For Chinese Drug Development

    Germany Rolls First CAR-T Push For Muscle Inflammation Cure

    More Monitoring Required of Institutional Review Boards

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    mAbs And Therapeutic Proteins Potency Guidance Issued By FDA

    Novel Purification Means For Protein Drug Manufacturing

    $118bn Sales By 2026 Is What Japanese Pharma Can Expect

    $118bn Sales By 2026 Is What Japanese Pharma Can Expect

    Duchenne Muscular Dystrophy-Cancer Genetic Link Discovered

    Animal Testing Could See An End With An Artificial Model

    Bioavailability Enhancement Market Projects CAGR of 11%

    Hong Kong Gives $500mn Funding For Chinese Drug Development

    Germany Rolls First CAR-T Push For Muscle Inflammation Cure

    More Monitoring Required of Institutional Review Boards

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development

mAbs And Therapeutic Proteins Potency Guidance Issued By FDA

Content Team by Content Team
9th March 2023
in Drug Development, News

The FDA has gone on to issue guidance on March 2, 2023 in order to give out recommendations to sponsors that will help in monoclonal antibodies- mAbs creation as well as other therapeutic proteins which go on to target host cell proteins or viral proteins that interfere with an infection’s pathogenic mechanism.

One of the critical quality control measures surrounding these products happens to be the execution of potency assays, which are adequate to ensure that there is a consistent production that takes place in each lot with the thrust that is necessary to attain clinical efficacy and that the potency gets maintained across the shelf life of the product.

According to the new guidance, a detailed recommendation to the drug manufacturers is provided with the objective of helping to make sure that drug developers give out necessary and precise information so as to access the potency at a product’s life cycle’s each and every stage.

Moreover, it describes approaches and processes the sponsors must make use of in order to develop the potency assay methods when it comes to the release and stability that go on to assess the comprehensively known or potential mechanisms that lead to the action of the product.

The new guidance also describes the methodology that the sponsors must make use of so as to ensure the potency of mAbs as well as other therapeutic proteins, which are made with the intent to prevent as well as treat viral infection.

Previous Post

Pharma Responds To The Statutory Scheme Surge By The UK

Related Posts

News

Pharma Responds To The Statutory Scheme Surge By The UK

9th March 2023
Drug Development

Novel Purification Means For Protein Drug Manufacturing

9th March 2023
$118bn Sales By 2026 Is What Japanese Pharma Can Expect
Drug Development

$118bn Sales By 2026 Is What Japanese Pharma Can Expect

2nd March 2023
Drug Development

Duchenne Muscular Dystrophy-Cancer Genetic Link Discovered

28th February 2023
News

Animal Testing Could See An End With An Artificial Model

28th February 2023
News

Bioavailability Enhancement Market Projects CAGR of 11%

28th February 2023

Latest News

Drug Development

mAbs And Therapeutic Proteins Potency Guidance Issued By FDA

9th March 2023
News

Pharma Responds To The Statutory Scheme Surge By The UK

9th March 2023
Drug Development

Novel Purification Means For Protein Drug Manufacturing

9th March 2023
Pharmapack 2023 a pivotal moment for sustainability in drug delivery and packaging
Europe

Pharmapack 2023 a pivotal moment for sustainability in drug delivery and packaging

3rd March 2023
$118bn Sales By 2026 Is What Japanese Pharma Can Expect
Drug Development

$118bn Sales By 2026 Is What Japanese Pharma Can Expect

2nd March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In