Excipients

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

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

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

With high-concentration biologics, careful selection of excipients in formulation is crucial for reducing viscosity without destabilizing the protein.

Roquette is investing €25 million at its site in Lestrem, France to strengthen its position in the polyols market.

Careful selection is essential for achieving viscosity reduction without protein destabilization.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

DFE’s new line will offer market purity and low endotoxin excipients for use in formulation, while providing drug developers and manufacturers high-quality excipient technology and services.

The company will join the network of approved manufacturers of the lipid excipients.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

With the acquisition, Evonik will expand its life science division and its portfolio of functional excipients and biomaterials.

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

CordenPharma announces expansion of lipid excipients supply for coronavirus vaccine scale up.

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

LBB Specialties and Meggle Excipients & Technology will work to distribute excipient products to companies in the American pharmaceutical and nutraceutical industries.

The transaction will reach completion during the fourth quarter of 2019.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

A solid lipid excipient from ABITEC is designed for multiple dosing forms.

The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

The company has opened new facilities and an innovation center in Singapore, China that will focus on the development of plant-based products.

There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

This article provides an overview on important aspects related to bracketing strategies in Japan.