Digitalization can improve workflow and output but maintaining data integrity is a concern.

Setting Up for Digital Transformation

A best practices approach to pharma’s most challenging-to-inspect container.

The Ins and Outs of Syringe Inspection

Alternatives to traditional freeze-drying may reshape biological development and the cold chain.

Beyond Lyophilization

Topic

Articles

The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

CGT Catapult Forms Consortium to Accelerate Manufacturing Technology Development

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

VIVEbiotech Launches Lentiviral Vector Manufacturing Plant for Cell and Gene Therapies

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

AGC Biologics to Supply More Plasmid DNA for Pfizer-BioNTech COVID-19 Vaccine

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

The Module Type Package standard is now supported in Emerson’s DCS and PLCs. 

Emerson Integrates MTP Process Automation Standard into Control Systems

Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines.

PNI to be Acquired by Danaher Corporation’s Life Sciences Platform

Feliza Mirasol is the science editor for 

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

Next-Gen Therapies Drive Development Technologies

Yan He is the senior scientist at BioSpherix, Ltd., 25 union St. Parish, NY

Shannon Darou is a technician at BioSpherix, Ltd., 25 union St. Parish, NY

Stassa P.D. Henn is an intern at BioSpherix, Ltd., 25 union St. Parish, NY

Rose Walter is an intern at BioSpherix, Ltd., 25 union St. Parish, NY

Randy Yerden is the chief executive officer at BioSpherix, Ltd., 25 union St. Parish, NY

Alicia D. Henn is the chief scientific officer, all at BioSpherix, Ltd., 25 union St. Parish, NY

Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants. 

Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without Disinfectants

Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.