APIs and Excipients

Excipients Impact Stability in mRNA-LNP Formulations

March 03, 2023

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Influencing Change in Drug Delivery

March 03, 2023

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

Drug Solutions Podcast: Progressing Excipients Through Review

February 21, 2023

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Preparing for a New Wave of mRNA Technologies

February 16, 2023

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

SuspendIt Anhydrous Introduced as New Compounding Base

January 11, 2023

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

January 11, 2023

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Updated REMS Document for Prescription, Biological Drug Product

January 11, 2023

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Managing mRNA Instability During Formulation, Manufacturing, and Shipment

December 03, 2022

Unique solutions are required to protect inherently unstable messenger RNA.

Biotech Startup Raises $5.4M to Develop AI-Designed Protein Machines and Cell Factories

November 21, 2022

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

Excipients for Solubility Enhancement of Parenteral Formulations

November 03, 2022

High-concentration injectable formulations present unique challenges.