Manufacturing

Articles

The RCS product line will be available to the public and was demonstrated for the first time at Automate 2023 in Detroit on May 22, 2023, following will be a launch to the European market at Automatica 2023 in Munich on June 27, 2023.

New Product Line Unveiled by Renishaw 

The new method was developed to isolate tissue-specific EVs from the blood in addition to using a workflow to analyze their diverse multi-omics content. 

Mursla Bio Discovers New Biomarker Approach in Precision Medicine

The first CleanCap analog was launched in 2017, and since then, the capping technology has been incorporated in one of the first commercially approved COVID-19 vaccines.

TriLink Biotechnologies Introduces CleanCap M6 Analog

According to a press release, SGS has doubled its capacity for nitrosamine testing for North American customers.

SGS Expands Nitrosamine Testing Capacity

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age. 


Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. 

FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

Lonza to Expand Capabilities at Manufacturing Sites in Switzerland

USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.

USAntibiotics Reopens Facility, Returning Antibiotic Production to the United States

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Manufacturing, Drug Products