Search results for " (ATMP)"
Article
GMP Challenges for Advanced Therapy Medicinal Products
They are a requirement of an EU regulation on ATMPs (2) which was approved in 2007.
The objective behind the guidelines is to bring together in a single document GMP standards from a variety of sou…
Article
Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…
Article
Early Communication with Regulators is Essential for SMEs
SMEs have been accounting for 75% of EMA’s small number of ATMP approvals, for which there were only three applications last year.
To provide an incentive for more SMEs to develop advanced therapie…
Article
Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…
Webcast
BPI Europe 2023 - May 9-12, 2023
Mark your calendar for Europe's leading bioprocessing event for accelerating next generation mAbs, novel modalities and ATMPs to commercial success.
Article
FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …