BioPharmaSpec Inc


BioPharmaSpec 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:




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





Liquid and Spectroscopic Profiling

Circular Dichroism


Intrinsic Fluorescence






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.




Festibval of Biologics


There are two parts to the Festival of Biologics: three conferences covering Antibodies, Immunotherapy, Biosimilars and an exhibition featuring solutions for pharma and biotech.