BioPharmaSpec Announces Major Investments in Mass Spectrometry and Related Instrumentation

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To further support Clients with the provision of their first-class characterization services, BioPharmaSpec has also expanded its overall analytical instrumentation portfolio with the Bio-Techne (Protein Simple) Maurice Flex icIEF, CE-SDS and cIEF instrument, two Shimadzu PPSQ-53A Gas Phase Sequencers and a Wyatt DAWN Ambient 18 angle Multi Angle Light Scattering with Integrated DLS and Optilab dRI detector. 

The instruments currently being installed and qualified across BioPharmaSpec’s global laboratories, further enhance BioPharmaSpec’s already impressive mass spectrometric, chromatographic and spectroscopic service provision.

Background

Specialization and Expertise

BioPharmaSpec is a Contract Research Organisation (CRO) specializing in the structural characterization and physico-chemical analysis of recombinant biopharmaceuticals including monoclonal antibodies (mAbs), Antibody Drug Conjugates (ADCs), Biosimilars and other Bio-active substances, with a focus on Discovery, Early and Pre-clinical phases of our Clients’ product developments.

BioPharmaSpec was formed by Prof Howard Morris (with 45 years of experience in pioneering biopolymer characterization methodology by Mass Spectrometry and founder in 1980 of the M-Scan group of companies) and Dr Andrew Reason (with 25 years of experience in commercialization of analytical methods for characterizing biopolymers and previously Group Manager of the European M-Scan laboratories and SGS M-Scan Europe).

With this background in innovation, our teams of expert scientists are skilled in the analysis of Biopharmaceutical products and the interpretation of novel and unusual structures, especially post-translational modifications (PTMs) where we have unparalleled experience in Glycosylation and Disulfide Bridge analysis.

BioPharmaSpec is therefore ready and able to help you advance your company’s research and product development.

Pioneering Techniques

Senior Scientists who are part of our BioPharmaSpec team originally pioneered the now well-accepted strategies of mass spectrometric Peptide Mapping [1,2,3], the use of mass spectrometry in Disulfide Bridge Assignment [4,5] and the discovery and characterization of important Glycosylation in natural and recombinant proteins [6,7,8,9,10].

They built on these basic protocols (now widely used in the field) to provide cutting edge discovery research and development as illustrated by (i) the characterization of 24 sites of N-linked Glycosylation in virion-derived gp120 from HIV-1 [11], (ii) the discovery of novel glycoprotein epitopes in hypervirulent strains of C. difficile and their characterization as sulfonated peptidylamidoglycans [12] and more recently the difficult characterization of a novel S-layer protein PTM Glycosylation of Clostridium difficile as a surprisingly long (>40 residues) filamentous polysaccharide terminating in a cyclo-Phospho sugar [15].

FDA Collaborative Research

In one of our collaborative publications with US researchers including the FDA [16], contrary to the belief that synonymous sequence-variant proteins are biologically inert, such variants are shown to impact protein expression and function.

Mass spectrometric peptide mapping using LCMS and MS/MS methods developed in our laboratories, was used by BioPharmaSpec to test for possible causative differences with respect to post-translational modifications (PTMs) on the 190kD ADAMTS13 normal and variant molecules, during which study several novel O- and C-Glycosylations were assigned for both molecular species.

SARS-CoV-2 Spike Protein Analysis

There is considerable current interest in the Covid-19 pandemic and the causative viral agent which gains access to human tissues via binding to the Angiotensin Converting Enzyme (ACE-2) receptor.

In work with Imperial College, London, BioPharmaSpec has characterized the site-specific glycosylation state of the SARS CoV-2 Spike Protein Receptor Binding Doman (RBD) construct from HEK293 cells, finding unusual Fucosylated LacDiNAc epitopes on the N-linked sites (Asn-331 and Asn-343) and a single high-occupation site of O-glycosylation on Thr-323 [17]. Other collaborative research with Genie Biotech on site-specific protein modification chemistry is leading to the introduction of new methods aimed at improving general vaccine effectiveness and virus-neutralizing ability [18].

Advanced Instrumentation

When using its Characterization Services, Clients access the full range of BioPharmaSpec expertise including the advanced Q-TOF [13] and Triple Quadrupole mass spectrometers announced above as our new investments in this Press Release.

These powerful advances will build on BioPharmaSpec’s current service offerings of classical gas-phase Edman sequencing services alongside proprietary methods allowing (i) the differentiation of Leu/Ile assignments in De-Novo sequencing projects, such as monoclonal antibody (mAb) characterizations, and (ii) the confirmation of N-terminal sequence and physico-chemical analyses including off-line liquid chromatography (RP-HPLC, IEX and SEC), electrophoresis (SDSPAGE and imaging capillary IEF), secondary and tertiary structure analysis (Circular Dichroism) and protein aggregation analysis (SEC-MALS) [14].

Partner with BioPharmaSpec

As an independent analytical research laboratory (CRO), BioPharmaSpec boasts a proven track record of solving cutting-edge challenges in biopolymer research. Our team of expert scientists is ready to leverage this extensive experience to provide efficient and accurate characterization of your biopharmaceutical products. Partner with us to advance your research and achieve your development goals.