Drug Development

Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.

To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.

Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.

Industry experts discuss the role of gene-editing techniques in regenerative medicine and cell-line development.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Bio/pharmaceutical companies are adopting artificial intelligence for discovery, development, risk assessment, safety monitoring, and manufacturing.

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.

Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.

Development and manufacturing machine specialists, groninger, have opened a new showroom at its headquarters based in Crailsheim, Germany.

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The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

The companies announced their collaboration to provide a human-induced pluripotent stem cell (iPSC)-based integrated platform for drug discovery solutions.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.

Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.

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

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

A presentation at the Leistritz Pharmaceutical-Nutraceutical Extrusion Seminar explained how simulation tools benefit the development process.

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

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.

A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.

In this collaboration, AbCellera will apply its expertise to generate panels of antibody candidates for Gilead to evaluate.

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

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.