Adopting single-use systems has implications for manufacturing execution systems, process data-analytics tools, and scheduling
Adopting single-use systems has implications for manufacturing execution systems (MES), process data-analytics tools, and scheduling. Enterprise resource planning and MES must be integrated using standards such as ISA-95. Master and electronic batch records must be designed to capture the details of single-use component assembly to enable traceability.
Read
BioPharm International’s 2014 Single-Use SystemseBook.
EXO Biologics and ExoXpert Reach Two Critical Milestones that Advance Exosomes
December 3rd 2024EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.