article thumbnail

Cell and Gene Therapy Bioassay – A Prerequisite for the ATMPs Development

Roots Analysis

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.

article thumbnail

How improved assay analysis benefits early drug discovery

Drug Discovery World

DDW Editor Reece Armstrong speaks to Abraham Wang , Head of Marketing at Collaborative Drug Discovery (CDD) about annotated assays and the advantages they bring to research teams. RA: What advantages can better analysis into assays bring to drug developers?

Drugs 59
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Toregem BioPharma and WuXi Biologics to partner for antibody development

Pharmaceutical Technology

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.

Antibody 130
article thumbnail

Using analytics and bioassays to de-risk your mRNA LNP drug development programme

Pharmaceutical Technology

“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 130
article thumbnail

Addressing the challenge of salt forms in drug discovery

Drug Discovery World

The research chemical supply market. It is estimated that there are around 30+ research chemical suppliers active in the screening compound market at any time providing some 10 million in-stock, varied compounds. The importance of salt forms in the commercially available chemicals market. Volume 23 – Issue 3, Summer 2022.

Drugs 52
article thumbnail

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. Drug discovery and development is an arduous process that can cost upwards of $2.6 In August 2022, the ICH issued an addendum to its S1B guidelines that allows certain drugs to forego two-year rat studies 1.

article thumbnail

What to expect from PEGS Europe 2023: Day 2

Drug Discovery World

The first three include: Sungjin Park, PhD, CEO, Onegene Biotechnology, on: ‘UniStac: Enzyme-mediated conjugation technology for accelerated development of tetraspecific NASH drug’. Ioanna Stamati, PhD, Team Leader, Bioconjugation, Antikor Biopharma, on: ‘Antibody fragment drug-conjugates (FDCs): Analysing novel formats with high DAR’.