Drug Development

How Pfizer’s external-facing research and development scientists uncover the most promising emerging therapy concepts and ideas in the pharmaceutical landscape.

The flow of capital and scientific acuity irrigates this pharm system.

Biopharmaceutical manufacturers must consider a surprisingly wide range of factors when deciding where to turn for assistance with cell line development.

It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.

API permeation into the skin modulates the efficacy of topical treatments.

It is possible to overcome some of the limitations of traditional dosage forms by employing alternative drug delivery formulation strategies.

A new unitary patent system is due to come into effect in Europe later on this year.

Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.

Scientists have developed a mouse model that could be a promising model system for research into factors affecting mammalian embryonic development and disease.

ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.

In this episode of the Drug Solutions Podcast, John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals shares outsourcing strategies in biopharma.

Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.

Amgen’s acquisition of Chemocentryx includes the autoimmune disease drug Tavneos (avacopan).

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Industry is adapting to the increasing complexity and poor solubility and bioavailability of molecules in the pipeline.

The purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.

Further advances in construct design and manufacturing scalability are still needed.

Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.

The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Promising applications for targeted delivery may be cresting the horizon.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.