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

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...

Traditional LVV manufacturing uses mammalian cellular substrates for virus production 1,2,3,4,5. The resulting virus harvest then undergoes a series of purification and concentration steps to generate ...

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 ...

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 ...

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 ...

This workshop will examine manufacturing and characterization capacity in the US for mid-scale production of sufficient quantities of emerging materials to assess the engineering utility of those ...

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 ...

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 ...