Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...

Process analytical technology in biomanufacturing has undergone a fundamental transformation over the past two decades, moving quality control from the analytical laboratory to the manufacturing floor ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...

In drug development many applications are found for lipid-based nanoparticles (Lb-NPs) as successful transporters for poorly water-soluble drugs and oligonucleotides in gene therapy. Major advantages ...

Thought LeadersRobert HighamHead of CfAMUniversity of Bolton/Centre for Advanced Manufacturing Granutools is a Belgian company that specializes in powder flow characterization; the University of ...

Matt Taylor is a senior process development associate at KBI Biopharma, where he focuses on the design, optimization, and scale-up of purification processes for biopharmaceutical manufacturing. Matt ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

Granutools is a Belgian company specialized in powder flow characterization; PrinterPrezz in California is the first medifacturing™ company in the world using 3D printing. Together they join forces to ...