Overview
BioPharmaSpec is a global contract research organization (CRO) specializing in structural and physicochemical analysis of biopharmaceuticals using advanced chromatographic, electrophoretic, and mass spectrometric techniques. They support protein characterization for monoclonal antibodies, antibody-drug conjugates (ADCs), therapeutic peptides, cell and gene therapies, oligonucleotides, and biosimilars, meeting global regulatory requirements like ICH Q6B. With over 45 years of expertise and new facilities in Europe equipped with state-of-the-art instrumentation, they offer comprehensive services including comparability testing, HCP identification, and gap analysis of existing data.
Frequently asked questions
- What biopharmaceutical characterization services does BioPharmaSpec provide?
- BioPharmaSpec offers structural, physicochemical, and biophysical characterization using techniques like peptide mapping, Edman sequencing, aggregation assessment, and mass spectrometry for monoclonal antibodies, ADCs, peptides, cell/gene therapies, oligonucleotides, and biosimilars.
- What regulatory standards does BioPharmaSpec comply with?
- Their services meet global regulatory requirements including ICH Q6B for biopharmaceutical characterization, providing regulatory-ready data for development, comparability, and biosimilar testing.
- Where are BioPharmaSpec's laboratories located?
- BioPharmaSpec operates global laboratories with new facilities in Germany, Italy, and Lithuania equipped with advanced instruments like Waters Select Series CYCLIC IMS, SCIEX ZenoTOF 7600, and Waters Xevo systems.