A Global Analytical Testing Lab for your Structural Characterization Requirements
BioPharmaSpec is a global contract research organization (CRO), led by pioneering industry experts in the field of mass spectrometry, specializing in the structural, physicochemical and biophysical characterization of biopharmaceuticals such as biosimilars and biobetters, monoclonal antibodies, Antibody Drug Conjugates (ADCs), gene therapy products (e.g. AAV based therapeutics), oligonucleotides, peptides and other recombinant proteins.
Protein Analysis Services
Using state-of-the-art chromatographic and Mass Spectrometric instrumentation and methods, BioPharmaSpec scientists use technical expertise built up over decades of pioneering research to assist our clients with their protein and glycan characterization and sequencing requirements:
Structural Characterization Services
- Protein structure and sequence confirmation, including identification of post-translational modifications
- Impurity identification, including HCPs
- de novo amino acid sequencing
- N- and C- Terminal Sequencing
- Amino Acid Analysis (AAA)
- Extinction coefficient determination
- Peptide mapping
- Disulfide bridge analysis
- Intact molecular weight
- Protein glycosylation analysis
- Monosaccharide analysis
- Oligosaccharide analysis
Physicochemical Testing Services
- Biophysical characterization, impurity analysis and protein aggregation analysis
- icIEF
- CE-SDS
- Liquid and Spectroscopic Profiling
- Circular Dichroism
- FTIR
- Intrinsic Fluorescence
- DSC
- DLS
- SEC-MALS
- SV-AUC
- 1D and 2D NMR
With BioPharmaSpec's support, solid development decisions can be made based on quality analytical data and experience.
The Story of BioPharmaSpec
BioPharmaSpec was formed in 2014 by Prof Howard Morris (with over 45 years of experience in protein characterization and founder of the M-Scan group of companies) and Dr Andrew Reason (with over 25 years of experience in commercialization of analytical methods for characterizing biopharmaceuticals and previously Group Manager of the European M-Scan laboratories and SGS M-Scan Europe).
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 as illustrated recently in a collaborative publication with US researchers including the FDA, or in our efforts in the fight against the Coronavirus (SARS-CoV-2) COVID-19 pandemic.
We Are Dedicated to Accelerating the Development of Your Biopharmaceutical
We support a broad range of biopharmaceutical characterization studies. Our clients use our analytical data to support many different areas of analytical characterization, such as choosing the best cell clone by assessing critical structural attributes, performing batch-to-batch or innovator to biosimilar comparisons, or adding HCP-MS to their host cell protein detection strategies.
We support your development program by providing protein analysis services including:
- Protein characterization services
- Protein sequencing services
- Peptide mapping services
- Protein glycosylation analysis
- Protein quantitation services
- Glycan characterization
- Protein aggregation analysis
- Mass spectrometry analysis
- Structural and physicochemical characterization to ICH Q6b
- Biosimilar testing
- Characterization of AAV vectors
- Oligonucleotide Characterization and Analysis
- Forced degradation and stability studies
- Process related impurity analysis
- Host Cell Protein detection and quantitation
See What Our Clients Have to Say
Our clients and their studies are our priority, and we are proud of the great feedback we receive from them.
“This was a complex study, further complicated by the sensitivity required to achieve useful data. We approached BioPharmaSpec after some other options had failed and were very pleased with how they used their technical expertise to achieve the sensitivity required and provide us with good data.” – Bioanalyst, MedImmune
“We use pDADMAC as a flocculation agent for one of our client’s protein products and needed to develop a robust method to identify and quantitate pDADMAC levels throughout the process. After unsuccessful attempts to develop a mass spec method in the past, we were delighted to find BioPharmaSpec and discover the specific technical expertise they had in this area. They developed a robust method that we use regularly to support this development project.” – Principal Scientist, R&D – Sekisui
Contact Us to Outsource Your Protein Characterization and Analytical Development Studies
As a reliable and scientifically-led CRO, we’re here to serve the biopharmaceutical industry by providing high quality structural and physicochemical protein characterization services. Talk to our scientists today!