News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The updated draft guidance calls for fully validated bioanalytical methods for any pivotal studies used to obtain approval or labelling, though less validation may be sufficient for a sponsor’s internal decision making.
Merck Millipore has launched a new range of depth filters that it claims overcome the shortcomings of traditional techs and clear a path to successful downstream clarification.
Cambridge Research Biochemicals (CRB) has licensed rights to a system that – it claims – will let biopharmas identify the best delivery peptides more quickly.
Single-use biopharma provider ATMI has invested in sterile connector and fill technology developed by Medical Instill Technologies.
BioGenes says a new panel of generic host cell protein (HCP) assays can help biopharmas save costs during process development.