APIs and Excipients

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.

Cambrex’s expanded quality control laboratory supports generic API development.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.

The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.

The multi-year agreement will give Novartis access to AbCellera’s expertise and state-of-the-art antibody discovery technology for up to ten clinically-relevant disease targets.

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

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

New platform technologies, advanced modeling tools, and addressing patient needs are important developments.

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

Antibody-based drugs offer new mechanisms of action and greater specificity.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.