In order to meet the generally high quality requirements for the pharmaceutical manufacturing process, medicaments of animal or human origin specifically have to undergo a substantial viral safety test program. This procedure has been narrowly defined in numerous internationally valid guidelines; in addition, registration authorities are available in an advisory capacity. In order to bring about the experimental evidence, thorough planning, virological expertise and infrastructure, as well as close cooperation between process engineers and virologists, is necessary. Generally, generic studies are not accepted by the registration authorities. However, in coordination with the German Federal Institute for Drugs and Medicinal Devices (BfArM), a special arrangement for homoeopathic preparations could be agreed upon and the efficacy of selected production stages proven beyond doubt. Therefore, combined with the careful execution and evaluation of the validation studies, a high technical status for biopharmaceuticals including homoeopathic preparations guarantees a very high degree of viral safety.
Download full-text PDF |
Source |
|---|
Publication Analysis
Top Keywords
Similar Publications
Characterization and genome analysis of lytic Vibrio phage VPK8 with potential in lysing Vibrio parahaemolyticus isolates from clinical and seafood sources.
Virol J
January 2025
Division of Biological Science, Faculty of Science, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.
Background: Vibrio parahaemolyticus is a marine bacterium causing seafood-associated gastrointestinal illness in humans and acute hepatopancreatic necrosis disease (AHPND) in shrimp. Bacteriophages have emerged as promising biocontrol agents against V. parahaemolyticus.
View Article and Find Full Text PDFH9N2 avian influenza virus diagnostics utilizing specific high-sensitivity enzymatic molecular system termed RPA-based CRISPR-Cas13a.
Int J Biol Macromol
January 2025
College of Veterinary Medicine, Shandong Agricultural University, Tai'an 271018, Shandong Province, China. Electronic address:
H9N2 avian influenza virus (AIV), a major pathogen causing respiratory infections in poultry, poses a significant threat to the poultry industry and human health. Early detection and control of H9N2 infections are essential for minimizing economic losses and preventing potential zoonotic transmission. A novel CRISPR-Cas family member called CRISPR-Cas13a comprises the CRISPR RNA (crRNA) and Cas13a nuclease.
View Article and Find Full Text PDFCepharanthine: A promising natural compound against feline infectious peritonitis virus infection and associated inflammation.
Virology
January 2025
National Key Laboratory of Veterinary Public Health and Safety, College of Veterinary Medicine, China Agricultural University, Beijing 100193, China; Key Laboratory of Animal Epidemiology of the Ministry of Agriculture and Rural Affairs, College of Veterinary Medicine, China Agricultural University, Beijing 100193, China. Electronic address:
Feline infectious peritonitis (FIP), a fatal disease in cats caused by feline infectious peritonitis virus (FIPV), has limited treatment options and lacks effective vaccines. Cepharanthine (CEP), a natural isoquinoline alkaloid, possesses many medicinal properties, including antiviral activities. However, the role of CEP in management of FIPV infection remains poorly understood.
View Article and Find Full Text PDFPotential Infectious Complications in Pig Xenograft Donors and Recipients.
Transpl Int
January 2025
Department of Biological and Biomedical Sciences, School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, Scotland, United Kingdom.
Preclinical and clinical xenotransplantation trials have shown that successful outcomes depend on a number of factors including the prevention of xenozoonoses. Preclinical trials involving pig kidneys and hearts transplanted into various non-human primates have revealed the potential impact of pig pathogens being present in the transplanted organ/tissue, mainly viruses. The concept of "designated pathogen-free donor animals" was developed to ensure elimination of pathogens during the breeding of donor animals to mitigate this occurrence.
View Article and Find Full Text PDFResearch on mixed sample test for the rapid detection of rice stripe virus and southern rice black-streaked dwarf virus in vector.
Virology
January 2025
Jiangsu Key Laboratory for Food Quality and Safety-State Key Laboratory Cultivation Base, Institute of Plant Protection, Jiangsu Academy of Agricultural Sciences, Nanjing, 210014, Jiangsu Province, China; International Rice Research Institute and Jiangsu Academy of Agricultural Sciences Joint Laboratory, Nanjing, 210014, Jiangsu Province, China. Electronic address:
Rice is a staple food in East and Southeast Asian countries, rice disease surveillance and warning is particularly important. Rice stripe disease and southern rice black-streaked dwarf virus disease are the insect-borne viral diseases that easily break out and quickly become epidemic. It is important to improve the efficiency of the virus detection method.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!