Newsletter | March 25, 2025

03.25.25 -- Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies'

FEATURED EDITORIAL

U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies'

The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

INDUSTRY INSIGHTS

High Affinity Therapeutic Antibodies Against Transmembrane Proteins

Here, we present a hybridoma-based antibody discovery and humanization strategy for a T1P target, utilizing Penta Mice immunization to generate monoclonal antibodies.

Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing

Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

Navigating Cell Therapy Process Development

Equip yourself with the knowledge necessary to make well-informed decisions by exploring the main challenges and considerations inherent in cell therapy process development.

Enabled Form Selection For Oral Drug Products

Review the role of solid form screening and PBPK modeling to enable accelerated timelines desirable in early-phase drug development. Explore formulation maps for ASDs and key criteria for salt screening.

Application Of A Novel Temperature Shift Process For Particle Engineering

Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

Purification And Solubilization Of Membrane Proteins For Cryo-EM Studies

See how Cube Biotech and MIT researchers used dynamic light scattering (DLS) and nano differential scanning fluorimetry (nanoDSF) to find the best nanodisc conditions for three membrane proteins.

MOST POPULAR NEWS

Valo Health And nference Announce Long-Term Partnership To Accelerate Human-Centric Drug Discovery And Development

Helix Launches 23,000-Patient Clinico-Genomic Cohort For Autoimmune Diseases To Advance Drug Discovery And Development

Sapio Sciences Makes AI-Native Drug Discovery Seamless With NVIDIA BioNeMo

Taiho Pharmaceutical To Acquire Next-Generation ADC Drug Discovery Company Araris Biotech

Xeris Announces Approval Of Supplemental New Drug Application (sNDA) Of Gvoke VialDx (Glucagon) For Use As A Diagnostic Aid

Precision BioSciences Announces Clearance Of Investigational New Drug Application By The U.S. FDA For First-In-Class PBGENE-HBV Designed To Eliminate Root Cause Of Chronic Hepatitis B

China's First IGF-1R Monoclonal Antibody: Innovent Announces NMPA Approval Of SYCUME For The Treatment Of Thyroid Eye Disease

CUHK Develops Novel Drug Formulation Method That Increases Efficacy Of Drugs

Pharmacy Professor Lands Prestigious Grant To Advance Drug Discovery

Alliance For Genomic Discovery Completes 250,000 Whole Genomes To Accelerate Drug Discovery

HiRO And Hallym University Sacred Heart Hospital Sign Strategic MOU To Advance Drug Development

SOLUTIONS

Cell And Gene Therapy Development From Altasciences

The Fast Track To IND