About

BioPharmaSpec is a Contract Research Organization (CRO) specializing in structural characterization and physico-chemical analysis of recombinant biopharmaceuticals including monoclonal antibodies and associated products, Antibody Drug Conjugates (ADCs), oligonucleotides, PEGylated proteins, vaccines, fusion proteins, coagulation factors, blood circulating hormones and Biosimilars. We assist our clients throughout the product development lifecycle, including Initial clone selection, Forced degradation studies, Full characterization (ICH Q6b), Comparability, Host Cell Protein analysis . Our scientists have built up their expertise over many years and we use state-of-the-art instrumentation and methods to support a number of analytical areas including: Primary de novo amino acid sequencing, N and C Terminal Sequencing, Amino Acid Analysis, Extinction coefficient determination, Peptide mapping & post-translational modifications (oxidation, deamidation, glycosyation, etc), Disulfide bridge analysis, Intact molecular weight, Monosaccharide and oligosaccharide analysis, Physicochemical and Biophysical characterization (icIEF, CE-SDS, Liquid and Spectroscopic Profiling, Circular Dichroism, FTIR, Intrinsic Fluorescence, DSC, DLS), Aggregation assessment (SEC-MALS, SV-AUC), NMR. BioPharmaSpec operates facilities in Malvern (PA, USA) and in Jersey (UK), and an office in India, making us a global service provider of high-quality analytical services. About BioPharmaSpec BioPharmaSpec is a Contract Research Organization (CRO) specializing in structural characterization and physico-chemical analysis of recombinant biopharmaceuticals including monoclonal antibodies and associated products, Antibody Drug Conjugates (ADCs), oligonucleotides, PEGylated proteins, vaccines, fusion proteins, coagulation factors, blood circulating hormones and Biosimilars. We assist our clients throughout the product development lifecycle, including Initial clone selection, Forced degradation studies, Full characterization (ICH Q6b), Comparability, Host Cell Protein analysis . Our scientists have built up their expertise over many years and we use state-of-the-art instrumentation and methods to support a number of analytical areas including: Primary de novo amino acid sequencing, N and C Terminal Sequencing, Amino Acid Analysis, Extinction coefficient determination, Peptide mapping & post-translational modifications (oxidation, deamidation, glycosyation, etc), Disulfide bridge analysis, Intact molecular weight, Monosaccharide and oligosaccharide analysis, Physicochemical and Biophysical characterization (icIEF, CE-SDS, Liquid and Spectroscopic Profiling, Circular Dichroism, FTIR, Intrinsic Fluorescence, DSC, DLS), Aggregation assessment (SEC-MALS, SV-AUC), NMR. BioPharmaSpec operates facilities in Malvern (PA, USA) and in Jersey (UK), and an office in India, making us a global service provider of high-quality analytical services. About BioPharmaSpec BioPharmaSpec is a Contract Research Organization (CRO) specializing in structural characterization and physico-chemical analysis of recombinant biopharmaceuticals including monoclonal antibodies and associated products, Antibody Drug Conjugates (ADCs), oligonucleotides, PEGylated proteins, vaccines, fusion proteins, coagulation factors, blood circulating hormones and Biosimilars. We assist our clients throughout the product development lifecycle, including: - Initial clone selection - Forced degradation studies - Full characterization - Comparability - Host Cell Protein analysis Our scientists have built up their expertise over many years and we use state-of-the-art instrumentation and methods to support a number of analytical areas including: Structural characterization • Primary de novo amino acid sequencing • N and C Terminal Sequencing • Amino Acid Analysis • Extinction coefficient determination • Peptide mapping & post-translational modifications (oxidation, deamidation, glycosyation, etc) • Disulfide bridge analysis • Intact molecular weight • Monosaccharide and oligosaccharide analysis Physicochemical and Biophysical characterization • icIEF • CE-SDS • Liquid and Spectroscopic Profiling • Circular Dichroism • FTIR • Intrinsic Fluorescence • MMS • DSC • DLS • SV-AUC • SEC-MALS • NMR BioPharmaSpec operates facilities Malvern (PA, USA), Jersey (UK), Freiburg (Germany), Bergamo (Italy) and Vilnius (Lithuania) and an office in India, making us a global service provider of high-quality analytical services. BioPharmaSpec is a Contract Research Organization (CRO) specializing in structural characterization and physico-chemical analysis of recombinant biopharmaceuticals including monoclonal antibodies and associated products, Antibody Drug Conjugates (ADCs), oligonucleotides, PEGylated proteins, vaccines, fusion proteins, coagulation factors, blood circulating hormones and Biosimilars. We assist our clients throughout the product development lifecycle, including initial clone selection, forced degradation studies, full characterization according to ICH Q6B, batch to batch comparability and Host Cell Protein analysis. We support a number of analytical areas including primary de novo amino acid sequencing, N-Terminal Sequencing, Amino Acid Analysis, Peptide mapping & PTM assessment, Disulfide bridge analysis, Intact molecular weight, Glycan analysis, icIEF, CE-SDS, SEC-MALS, SV-AUC and higher order structure analysis (MMS, CD, FTIR, Intrinsic Fluorescence, DSC, DLS and NMR).