European Pharmaceutical Review

APRIL 27, 2023

Challenges in gene therapy manufacturing Photo: courtesy of PTC Therapeutics The biotech industry is facing a bottleneck in product manufacturing, with more than 1,000 gene therapies currently being developed as potential clinical candidates, 1 and not nearly enough capacity in manufacturing facilities to accommodate them.

Manufacturing 97

Manufacturing Food and Drug Administration Pharmaceutical products Food 97

European Pharmaceutical Review

AUGUST 9, 2022

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Regulatory Compliance: Compliance with regulations must be fully understood by representatives.

Sales 52

Sales Pharmaceutical Ethics Pharmaceutical Sales 52

European Pharmaceutical Review

APRIL 8, 2025

They should remain informed, knowledgeable of the PAT, monitor compliance regularly, especially if PAT is directly involved in drug substance production and the instruments are product-contact and in the regulatory filing dossier. Q10 Pharmaceutical Quality System. International Council for Harmonisation (ICH), 2012.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52