News

Article

EDQM Releases Document on Recombinant Viral Vectored Vaccines for COVID-19

Author(s):

Pharmaceutical Technology Editors

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

The European Directorate for the Quality of Medicines and HealthCare (EDQM) announced on Nov. 3, 2020 the release of a document that discusses the control of viral vectored vaccines. The document was created in collaboration with the European Pharmacopoeia Group of Experts on vaccines for human use to support COVID-19 vaccine developers.

The document, titled “Recombinant Viral Vectored Vaccines for Human Use”, provides analytical strategy options for the control of recombinant viral vectored vaccines and includes recommendations on tests that can be used as an aid “in building appropriate analytical strategies,” EDQM stated in a press release. Topics covered in the document include substrate for recombinant viral vector propagation, recombinant viral vector seed lot propagation and harvest, purified harvest, final bulk, and final lot.

Source: EDQM​

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
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
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
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content
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.
Oil painting of maze with figure finding way through. Perseverance, problem-solving. Birds fly above labyrinth at sunset. Concept of challenges, resilience, journey, overcoming obstacles in business | Image Credit © Vadym - stock.adobe.com
July 25th 2025

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Christopher Cole
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and analytical issues despite early regulatory guidance. Review key risk points in analytical and tech transfer to better ensure commercial readiness.
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.
Mercury. Element 80 of the periodic table of chemical elements. | Image Credit: © N. Elkha - stock.adobe.com
July 24th 2025

Opposing Reactions as RFK Jr. Removes Thimerosal from Flu Vaccines

Patrick Lavery
Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.
Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com
July 23rd 2025

ICH Q12 and Post-Approval Changes–Less than Satisfactory State of Affairs

Siegfried Schmitt
Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.