Development

Articles

Ajinomoto and its subsidiary company, Ajinomoto Genexine, have partnered with Insilico Biotechnology to accelerate and improve process development and production of biologics using digital twin technology.



Partnership Aims to Accelerate and Improve Smart Bioprocess Development Solutions

 is an AFI member and participates in the AFI process validation working group.

Alessandro Regola is the AFI vice president in Milan and coordinator of the AFI Quality Section, and serves as pharmaceutical consultant in quality systems.

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years

Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing

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

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

Jennifer Markarian is manufacturing editor of 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

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

Pfizer and Arvinas to Develop and Commercialize Estrogen Receptor Targeting Breast Cancer 

Modeling the manufacturing process benefits both development and operations. 

Process Development