More guidance is needed on the appropriate control of non-mutagenic impurities during clinical development, explains Dave P Elder, JPAG Member and pharmaceutical industry consultant, in this audio interview.
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Issue 2 2018
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Limulus amebocyte lysate (LAL) users, compendial experts and regulators are still orienting themselves to the recombinant factor C (rFC) assay. Changes to compendial standards do not occur overnight and, for now, users willing to change must perform the alternative validation procedure USP .
Pyrogen testing of drug products for parenteral administration is a mandatory task. Regulatory authorities require that each batch of drug product is pyrogen-free. Historically, the rabbit pyrogen test (RPT) was the required test but in most cases can be replaced by the endotoxin specifi c Limulus Amebocyte Lysate (LAL) test.
There have been many changes in pharmaceutical microbiology as we progressed into the 21st century. Some of these changes have been due to the advance of rapid microbiological methods, knowledge gained from the study of the human microbiome, while others are changes to conventional testing methods. This paper discusses some…
Wickham Laboratories Ltd, backed by five decades of global experience in Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) contract testing, is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. We conduct business with clients worldwide and the combined expertise of…
Eurofins’ PSS Insourcing Solutions® (PSS) employs and manages full-time scientists, managers and support staff to perform a defined scope of work at a client’s facility.
Charles River Microbial Solutions believes data drives every decision in the lab, so ensuring it is accurate, relevant, and reliable is critical to support confident decisions on product quality and safety.
Butterworth Laboratories Ltd is a UK-based contract laboratory providing analytical chemistry services to the global pharmaceutical industry in support of R&D, clinical development and licensed manufacture. We are GLP, GCP and GMP compliant, FDA and MHRA inspected.
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc., (ACC), specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using Food and Drug Association-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
In this In-Depth Focus; enabling the manufacture of robust biologic drug products, automating biopharmaceutical development, and greater compatibility and ease of use for bioproduction monitoring of monoclonal antibodies.
In this In-Depth Focus; early biotherapeutic lead optimisation for more efficient drug discovery and development, and turning promising compounds into drug candidates.