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. “At

Bioassay 130
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.

Insiders

Sign Up for our Newsletter

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

article thumbnail

KBI Biopharma Completes Eurofins DiscoverX Products Specialized Bioassay Certification Program

BioTech 365

& … Continue reading →

article thumbnail

Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

Formulating products that have the proper composition, viscosity, texture, and stability, and can also be shown to be safe and effective, is both a science and an art. Without proper precautions, knowledge gaps can occur and important details may be overlooked when a product is transferred from one site to another. Simplicity matters.

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

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

Reimagining cell engineering with picodroplet microfluidic technology

Drug Discovery World

However, standard technologies used to ensure the highest value cells are progressed require multistep operations and instruments, extensive hands-on time, and lengthy liquid handling processes, as well as complex, low throughput bioassays for functional validation and verification.