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BioPharmaSpec

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) and blood circulating hormones.

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:

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

  • icIEF
  • CE-SDS
  • Liquid and Spectroscopic Profiling
  • Circular Dichroism
  • FTIR
  • Intrinsic Fluorescence
  • DSC
  • SV-AUC
  • NMR

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

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

https://biopharmaspec.com
services.usa@biopharmaspec.com
BioPharmaSpec Inc 363 Phoenixville Pike Malvern, PA 19355 USA

+1 610-640-5866