The FDA has published its considerations regarding CGT products in a new draft guidance. The purpose of this guidance is to provide recommendations for managing manufacturing changes and assessing comparability for both investigational and approved human CGT products, taking into account the unique challenges that apply to these products.
Publication of EMA Document on the Establishment of a Guideline on mRNA Vaccines
More and more authorities are trying to create regulations for the production of new technologies by publishing guidelines. In this case, the European Medicines Agency (EMA) is asking for assistance in developing a guideline on the manufacturing of mRNA vaccines.
2nd Version of the USP Draft Guidance on mRNA-based Therapeutics
Because the application of mRNA technology is relatively new, regulatory guidelines and industry standards to govern non-compatible aspects of mRNA quality during development and manufacturing are still evolving. The USP has now defined standards and is seeking input during the comment period on a new draft guidance version for the analysis of mRNA.
Artificial Intelligence/Machine Learning in the Analysis of Biotherapeutics
The complexity of therapeutic protein-based medicinal products makes characterisation of these products difficult. However, the use of artificial intelligence and machine learning in flow imaging microscopy opens up new possibilities.
Potential Assays for Monoclonal Antibodies and Other Therapeutic Proteins
The FDA recommends and provides guidance on potency assays for monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins that mediate pathogenic mechanisms of infection. The purpose of this FDA guidance is to assist in the development and implementation of such assays to ensure adequate information on efficacy throughout the shelf life of the product.
Guidance on the Identification of Medicinal Products
With the guidance "Identification of Medicinal Products - Implementation and Use" published in March, the FDA addresses all those involved in the submission of medicinal product data.
FDA Recommendations to reduce HIV Transmission through Blood and Blood Products
The FDA has revised the guidance regarding recommendations for blood establishments to defer donors for persons with an increased risk for human immunodeficiency virus (HIV) transmission.
Publication of the 21st Edition of the EDQM Blood Guide
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 21st edition of the "Guide to the preparation, use and quality assurance of blood components".
Transmission of Malaria by Blood Donors - FDA updates Guidance Document
As a result of the specifics of the pandemic situation over the past two years, the FDA is issuing an update to its recommendations for reducing malaria transmission during transfusions. It replaces the April 2020 guidance.
FDA Information on bacterial Contamination of Platelets for Transfusion
After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.
ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis
The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.
ICH Q5 A (R1) Revision: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.
Warning Letter in the Area of Allogenic Umbilical Cord and Amniotic Membrane Products
During an inspection at the end of 2021, the FDA identified a manufacturer of umbilical cord blood products as lacking approval as well as numerous deviations with regard to common GMP requirements.