Report Outlook

The development of novel human biotherapeutics and vaccines requires analytical methods to ensure quality, safety, and efficacy.  These analytical methods must have high precision, linearity, accuracy, and specificity to meet the regulatory requirements for human clinical testing and commercialization.  As new types of complex biotherapeutics become increasingly popular, analytics is being challenged to adequately characterize larger and more diverse products, such as cell therapies, antibody-drug conjugates, bispecific antibodies, viral-like particles, and lipid nanoparticles.  All of these types of complex therapies have their own unique characteristics that require non-standard, purpose-built analytical platforms.