Drug Development

Articles

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

Poseida Therapeutics and Takeda Partner to Develop Non-Viral In-Vivo Gene Therapy Programs

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Meg Rivers is the former senior editor for 

Alternatives to animal testing and in-vivo assays are occurring as a result of recent scientific advances.

In Vivo Falls Behind In Vitro for Adventitious Agent Testing

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

Only 10% of Americans Understand the Drug Development Timeline, Survey Finds

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

Celsion and Poly Pharm to Manufacture Celsion’s DNA-Based Vaccine

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Moderna and ILCM Announce Collaboration to Develop mRNA Therapeutic for CN-1

Corning’s new Ascent fixed bed reactor (FBR) system is an automated bioproduction platform designed to significantly improve yields and reduce bioproduction costs.

Corning’s New Cell and Gene Therapy Platform Demonstrates Large-Scale Bioproduction

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

GoSilico Digital Twin Models Downstream Bioprocessing

AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.

AGC Biologics Acquires Cell and Gene Therapy Commercial Manufacturing Facility

The companies collaborate to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor protein degrader.

Process and Scaling