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“At the small scale, manufacturing between 1 ml and 10 ml is typically not problematic , but it’s not straightforward to replicate processes and technologies once you want to produce tens of litres of formulations,” says Dr Crowe, who manages a team that develop novel analytical assays related to LNPs and nanomaterials for drug delivery.
Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance.
As part of the collaboration, Toregem will use WuXi Biologics’ integrated CMC services in cell culture development, cell line development, bioassay development, biologics GMP manufacturing, cell banking and testing services, as well as other related services. TRG035’s Phase I clinical study is scheduled to begin in early 2024.
Understanding the mechanism of PPIs and developing methods to target aberrant ones has been a key strategy in drug development. In comparison with the classic, small molecule drug discovery approach, the modulation of PPIs is more challenging. Current challenges and conventional approaches in targeting PPIs. Charlotte Di Salvo.
Nat Rev Drug Discov. The obesity epidemic and food addiction: clinical similarities to drug dependence. J Psychoactive Drugs. Curr Drug Abuse Rev. Addicted to Palatable Foods: Comparing the Neurobiology of Bulimia Nervosa to that of Drug Addiction. Aspartame bioassay findings portend human cancer hazards.
Cambrex performs validated IVRT on product development batches and also offers a range of bioassays to demonstrate product potency when applicable. Microbial bioassay – measures the potency of a biological active substance (e.g., Fixed dose combination drugs: Case study. In vitro release testing to demonstrate bioequivalence.
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