Development

Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.

Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.

The editors welcome technical article contributions from biopharma industry experts.

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

Medical researchers from the Centenary Institute and the University of Sydney in Australia have managed to successfully develop and test a new vaccine targeting tuberculosis.

GSK will handle the development, regulatory, commercialization activities, and costs of the drug, while Ionis will obtain license fees and milestone payments of up to $262 million, including a $25 million license fee.

The partnership aims to establish a virtual R&D center to advance the development of new cancer therapies.

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.

Experts explore the role gene-editing techniques can play in regenerative medicine and cell-line development.

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?

This article explores the challenges and potential of next-generation therapeutic antibodies.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.