Drug Development

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.

STA Pharmaceuticals and BioLingus have announced the formation of an exclusive technology and marketing collaboration for sublingual delivery.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

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.

The agency clarified the process for development programs for regenerative medicine therapies.

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.

CatSci has announced an expansion of its offering to include end-to-end services with an additional focus on lead optimization.

Pathios Therapeutics and Sygnature Discovery have signed a strategic and innovative partnership agreement aimed at accelerating Pathios’ drug discovery and development programs.

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.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

PDA survey and conference discussion will generate information to guidance on technology transfer.

A study funded by the National Institutes of Health has created a virtual library expected to expand the availability of “make-on-demand” molecules for drug discovery.

The companies will develop Amprologix’s lead epidermicin-based antibiotic candidate.

In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.

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

Company launches new services dedicated to emerging biotech and biopharma companies.

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.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

The challenge of achieving sustained delivery of an active ingredient or nutrient can be achieved with extended-release formulations.

Leveraging vast quantities of analytical data requires digitalization and platform integration.

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.

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

Lonza and Takeda have furthered their multiproduct partnership through collaborative efforts on a new cancer treatment-Alunbrig (brigatinib).

Modular and podular laboratory and manufacturing allow rapid reconfiguration to support development of drugs for diverse patient populations.

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

Researchers at the University of Delaware have made a step forward in gene therapy by engineering microparticles that deliver gene-regulating material to hematopoietic stem and progenitor cells, which live deep in bone marrow and direct the formation of blood cells.