December 4th 2024
EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
PDA/FDA Joint Regulatory Conference: Product Quality Risk in Aging Facilities
September 11th 2024During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.
The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical Manufacturing
August 11th 2024The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.
Lonza Adds Bottling, Labeling Capabilities to Clinical Manufacturing Services at US Site
August 6th 2024The new additions to the company’s equipment at its early phase clinical manufacturing facility in Oregon will allow for cleaning, filling, capping, and sealing, and also detecting defects in drug products.