All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

News

Article

October 15, 2020

Pharmaceutical Technology

Pharmaceutical Technology-10-15-2020
Volume2020 eBook
Issue 3
Pages: 52-58

Viral Vector API Characterization of Product-Related Impurities

Author(s):

Peter Wunderli,Jun Lu

FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

In January 2020, the FDA issued Final Guidance for Industry: Chemistry Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) and other guidance documents for human gene therapies, which set expectations for manufacturing and demonstration of quality (1). These products are applied to deliver genetic material (transgenes) or modified cells that have been designed to alleviate or even eliminate a broad range of diseases that are rooted in the genetics of individuals or populations of patients.

Read this article in Pharmaceutical Technology's Regulatory Sourcebook October 2020 eBook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook
October 2020
Pages: 52-58

Citation

When referring to this article, please cite it as P. Wunderli et al., “Viral Vector API Characterization of Product-Related Impurities," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).

Articles in this issue

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1
Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1
Enhancing Process Validation for Solid Oral Dosage Forms: Part 2
Enhancing Process Validation for Solid Oral Dosage Forms: Part 2
Due diligence
Due Diligence Assessment of CMC Activities
Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?
Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?
Tackling Cybersecurity Challenges in Legacy Systems
Tackling Cybersecurity Challenges in Legacy Systems
POLINA - STOCK.ADOBE.COM
Ending ‘Magical Thinking’ in Compounding
luchschenF - Stock.adobe.com
Viral Vector API Characterization of Product-Related Impurities
TEX VECTOR - STOCK.ADOBE.COM
Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation
Strong Quality Culture: A How-To for Busy Managers
Strong Quality Culture: A How-To for Busy Managers
tashatuvango - Stock.adobe.com
Resources, Guidelines, and Guidance Documents
Regulatory and Standard Setting Organizations
Regulatory and Standard Setting Organizations

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Simona Guidi, Associate Director, ProPharma
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content
Advertisement
medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts – stock.adobe.com
July 25th 2025

Interfering with Interventions in Aseptic Processing

James Agalloco
Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
3d render. Pharmaceutical manufacture background with glass bottles with clear liquid on automatic conveyor line. COVID-19 mRNA vaccine production platform. | Image Credit: © wacomka - stock.adobe.com
July 22nd 2025

Pack Expo Las Vegas Marks 30th Anniversary with New Experiences for 2025

Patrick Lavery
The trade show is expected to draw 35,000 attendees to a show floor netting more than 1 million square feet.
Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail
May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
TOP NEWS on grunge world map | Image Credit: © Sean K - © Sean K - stock.adobe.com
July 21st 2025

FDA Appoints New CDER Director, George Tidmarsh

Susan Haigney
George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.
3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com
July 17th 2025

The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

Christopher Cole
A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.
Related Content
Advertisement
medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts – stock.adobe.com
July 25th 2025

Interfering with Interventions in Aseptic Processing

James Agalloco
Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
3d render. Pharmaceutical manufacture background with glass bottles with clear liquid on automatic conveyor line. COVID-19 mRNA vaccine production platform. | Image Credit: © wacomka - stock.adobe.com
July 22nd 2025

Pack Expo Las Vegas Marks 30th Anniversary with New Experiences for 2025

Patrick Lavery
The trade show is expected to draw 35,000 attendees to a show floor netting more than 1 million square feet.
Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail
May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
TOP NEWS on grunge world map | Image Credit: © Sean K - © Sean K - stock.adobe.com
July 21st 2025

FDA Appoints New CDER Director, George Tidmarsh

Susan Haigney
George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.
3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com
July 17th 2025

The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

Christopher Cole
A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.
About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.