Newsletter | January 9, 2024

01.09.24 -- Introduction To The New ASTM E3418


Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices

The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.

Best Practices For Preformulation In Drug Development

Preformulation testing encompasses all studies performed on a new drug compound in order to produce useful information for subsequent formulation of a suitable drug dosage form. There is preformulation across the stages of drug discovery, early development, and late development. The route of administration dictates what is important.


RNA's Advantages Over Other Cell Therapies With Cartesian's CSO

Dr. Michael Singer, CSO at Cartesian Therapeutics, details why RNA has advantages over other cell therapies, the company's three RNA trials, and the therapeutic benefit of multiple modifications.


Weill Cornell Medicine Receives Grant For Blood Test To Diagnose Breast Cancer

Molecular Diagnostics Research That Could Transform Healthcare

Frontage Laboratories Acquires Accelera S.r.l.'s Bioanalytical And DMPK Businesses

Baylor Genetics Combines Clinical & Scientific Expertise With Commercial Capabilities

Bionano Labs Publishes 1st Framework For The Clinical Implementation Of OGM Workflow

New Blood Exam Tested At Sparrow Receives FDA Clearance

DCU Research Team Successfully Test New Diagnostic Nanotechnology At Scale

Allogene Therapeutics & Foresight Announce Partnership To Dev MRD-Based In-Vitro Diag

OraSure Technologies, Inc. Secures Strategic Distribution Rights & Invests In Sapphiros

Asensus Surgical Completes In Vivo Surgeon Lab For LUNA Surgical Robotic System

Grabner Instruments Launches New Autosampler With Improved Technical Performance