Multivariate spectral analysis and monitoring for biomanufacturing

A method, comprising:

• obtaining a vibrational spectrum of a solution comprising a biological product in a biological manufacturing system;
• analyzing the vibrational spectrum using a first chemometrics model to determine a value of a first quality attribute associated with the solution;
• analyzing the vibrational spectrum using a second chemometrics model to determine a value of a second quality attribute associated with the solution;
• and
• adjusting at least one parameter of a chromatography column of a purification unit of the biological manufacturing system based on at least one of the values of the first and second quality attributes,
• wherein the biological product comprises at least one member selected from the group consisting of:
• a protein-based therapeutic substance comprising at least one of a protein, a peptide, an antibody, and an enzyme;
• a nucleic acid-based drug substance comprising at least one of DNA, a plasmid, an oligonucleotide, an aptamer, a DNAzyme, an RNA aptamer, an RNA decoy, a microRNA fragment, and a small interfering RNA fragment;
• and
• a gene therapy drug substance.