APIs and Excipients

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

New CDMO facility supports early-stage API manufacturing and scale up.

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

Pfizer’s acquisition of Array BioPharma expands the company’s pipeline of investigational cancer therapies.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

StarTab from Colorcon was designed to ensure functionality and stability for direct compression tableting.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Ashland introduces Klucel EXF Ultra HPC, a low friability, high strength binder.

Automated candle and pressure-plate filtration equipment for removing catalyst residues from API slurries are operated in a closed system.

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.