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Awesome hospitality & fantastic office. All the best!

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Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

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Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

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Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

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Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

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Analytical Arsenal for Biosimilarity Assessment

06 Mar 2018

Focus Area: Capillary Electrophoresis and Mass Spectrometry

Capillary electrophoresis (CE) is a powerful analytical technique for the separation of charged analytes, offering uniquely high analyte resolution. The advantages of CE include ease of automation, small sample volume requirement, robust separation efficiency and short duration of analysis.

CE is a robust and reliable technique, and has a proven track record in biopharmaceutical development. It has diverse applications ranging from molecular weight determination, charge variant analysis, N-glycan identification and isoforms analysis. It is often used to demonstrate biosimilarity of a potential candidate. It has been inducted by major pharmacopoeia, both Indian and European, for capillary zone electrophoresis (CZE) analysis of Erythropoietin.

Recent advancements with the hyphenation of CE and mass spectrometry (MS), CE-MS can offer a multitude of benefits – higher sensitivity for both smaller metabolites and larger proteins; minimal sample requirements, which is a significant advantage typically in the range of nanoliters; metabolic and peptide profiling of ultra precious biological fluids including cerebrospinal fluid and synovial fluid analysis, which can be seamlessly achieved on sheathless CE-MS platform. The minimization of biological fluid volumes opens attractive new possibilities for longitudinal studies.

Large biotherapeutics, including mAb’s, are highly complex and display micro-heterogeneities which require multiple analytical methods for a detailed structural assessment and quality control. As a consequence, the characterization on different levels is cumbersome and exhaustive. Capillary electrophoresis-electrospray ionization-mass spectrometry (CESI-MS) can perform multi-level characterization.

Lambda Biosimilars team is geared towards offering a panoply of diverse biopharma services including


  • Oxidation and Acetylation of drug substances
  • Amino acid substitution characterization: Biosimilar vs Innovator drug candidate comparison
  • Detection of critical post-translational modifications (PTMs)
  • Identification of glycan-amino acid linkage position
  • Separation and relative quantification of glycovariants with ultra-high sensitivity and broad range
  • Structural characterization of glycosylation
  • Charge heterogeneity analysis
  • Disulphide linkage analysis
  • Identification of heavy chain dimer peak


Biopharmaceutical industry operates under a highly regulated environment; minor structural/functional attributes between biosimilar and innovator need to be critically examined to avoid any delay for market authorization approval. Fortunately, by deploying powerful analytical tools, including CESI-MS, one can mitigate the challenges and Godspeed towards global regulatory clearances.

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