Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool
For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.
FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis
In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers".
Do liquid, sterile medicinal products have to be particle-free?
According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.
ATMPs in combination with a medical device - QP task on release
With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.
How to handle possibly lifesaving OOS batches of ATMP - A question that concerns manufacturers and authorities
In the context of a Q&A document, the European Medicines Agency (EMA) offers assistance and information on when an Advanced Therapy Medicinal Product (ATMP) can be approved for treatment even in the case of an out-of-specification batch.
Transmission of multiresistant microorganisms during transplantation
Following incidents involving the transmission of multi-resistant germs during the use of faecel microorganisms for transplantation, the FDA has established additional measures to minimise the risk of transmission.
Monographs on Vaccines and Immunosera - Revised Expert Guidance
During its 162th session, the European Pharmacopoeia Commission published the revised guideline "Guide for the elaboration and use of monographs on vaccines and immunosera for human use", which helps experts and interested parties in this field to prepare and interpret the monographs.