INDUSTRIES
We support product development of biological, pharmaceutical, gene therapeutic, and medical devices from research and development to late clinical phases.
Proteins including monoclonal antibodies can be tested for content, aggregation, charge heterogeneity, and other impurity content. Sample types include cell media, raw materials, filtrate pools, drug substance, and final drug product.
BIOTECHNOLOGY
Plasmid DNA can be characterized for topoisomeric purity, multimeric species, and content. Sample types include filtrate pools, drug substance, and final drug product.
GENE THERAPY
Small molecules can be tested for purity, potency, identity, and impurity content. Samples types include raw materials, intermediates, drug substance, and final drug product.
PHARMACEUTICAL
Medical devices serving to deliver drug and/or protein can be tested for drug load, drug release, impurity content, and chemical impact by sterilization. Sample types include raw material, in-process, pre-sterilized and post-sterilized combinational devices.
COMBINATIONAL MEDICAL DEVICE
It is great pleasure to help start-up companies that have promising products but not a laboratory. We thrive in relationships where our services are more than those for single stand-alone project. We can apply our experience to help with sampling, specifications, and filings as they pertain to chemistry, manufacturing, and control.