BioPharmaSpec

BioPharmaSpec is a global Contract Research Organization specializing in the structural and physicochemical characterization and testing of biopharmaceuticals. From locations in the United Kingdom, USA and Europe (Germany, Italy and Lithuania) BioPharmaSpec supports the biopharmaceutical industry in the cost-effective characterization of therapeutic products.

BioPharmaSpec was formed by Prof Howard Morris (founder of the M-Scan group of companies) and Dr Andrew Reason (previously Group Manager of the European M-Scan laboratories).

Scientists who are now part of the BioPharmaSpec team originally pioneered the now well-accepted strategies of mass spectrometric peptide mapping, the use of mass spectrometry in disulfide bridge assignment and the discovery and characterization of important glycosylation in natural and recombinant proteins. They continue to be involved in cutting edge discovery research and development including collaborations with the FDA and academic institutions, such as the work described in a joint publication with Imperial College, London, describing the characterization of the site-specific glycosylation state of the SARS CoV-2 Spike Protein Receptor Binding Doman (RBD).

The technical expertise at BioPharmaSpec includes the structural characterization and biophysical/ physicochemical analysis of recombinant biopharmaceuticals such as biosimilars and biobetters, monoclonal antibodies, Antibody Drug Conjugates (ADCs), gene therapy products (i.e. AAV- based therapies), peptides, oligonucleotides and many more product types, with a focus on discovery, early and pre-clinical phases.

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 and Biophysical

• icIEF

• CE-SDS

• Liquid and spectroscopic profiling

• Circular Dichroism

• FTIR

• Intrinsic Fluorescence

• DSC, DLS

• SEC-MALS, SV-AUC

• 1D and 2D NMR

Our analytical data helps our clients understand the structural attributes of their product, 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 host cell protein analysis using Mass Spectrometry (HCP-MS).

• Process related residuals and impurity analysis.

With BioPharmaSpec's support, solid development decisions can be made based on quality analytical data and experience.