APIs and Excipients

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.

Examining Trends in Oral Solid Dosage Manufacturing

November 03, 2022

The state of oral solid dose manufacturing is influenced by new approaches, novel technologies, and the structural evolution of the raw materials market.

Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program

November 01, 2022

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

Roquette Launches Next-Generation Direct Compression Solutions

October 31, 2022

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

Emerging Applications of Vitamin E TPGS in Drug Delivery

October 15, 2022

The author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.

FDA Expands Oversight of Cell and Gene Therapies

October 12, 2022

CBER maps modernization plan to handle surge in research and applications.

Electrochemistry for API Synthesis

October 03, 2022

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.

Biologic Standards in the Pharmacopoeias: An Update

October 02, 2022

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.