BioPharmaSpecBioPharmaSpec is a US and UK-based CRO, specializing in the structural and physicochemical characterization and testing of Biopharmaceutical Products. From our laboratories in the United Kingdom and Pennsylvania, USA, we help our clients get their biopharmaceutical products into clinical trials more cost effectively and quickly.
Our technical expertise includes the structural characterization and physicochemical analysis of recombinant biopharmaceuticals such as biosimilars and biobetters, monoclonal antibodies, Antibody Drug Conjugates (ADCs), peptides, blood circulating hormones etc.
Using state-of-the-art Chromatographic and Mass Spectrometric instrumentation and methods, BioPharmaSpec applies expertise built up over 45 years of pioneering research, to assist clients in a number of analytical areas:
Structural
Primary de novo amino acid sequencing
N and C Terminal Sequencing
Amino Acid Analysis
Extinction coefficient determination
Peptide mapping
Disulfide bridge analysis
Intact molecular weight
Monosaccharide analysis
Oligosaccharide analysis
Physicochemical
icIEF
CE-SDS
Liquid and Spectroscopic Profiling
Circular Dichroism
FTIR
Intrinsic Fluorescence
DSC, DLS
SEC-MALS, SV-AUC
NMR
Our analytical data can help our clients choose the best cell clone, provide batch-to-batch comparisons or make innovator to biosimilar comparisons. We support activities such as:
· New, innovative product characterization
· Structural and physicochemical characterization to ICH Q6b
· Comparability studies
· Biosimilarity studies
· Forced degradation studies
· Stability studies
· Product impurity analysis and quantitation, including HCP-MS.
With BioPharmaSpec's support, solid development decisions can be made based on quality analytical data and experience.
