Analytical Arsenal for Biosimilarity Assessment
30 Mar 2018
Biosimilars Debut: Emerging Opportunities in Biopharma Industry
Biosimilars are biologics containing the same active ingredient as the originator. Biosimilars have the exact amino acid composition and highly similar glycosylation patterns overlapping with the originator reference product. Biosimilar protein characterization studies involve extensive structural characterization and include an impressive arsenal of mass spectrometry (MS) based techniques required as per various regulatory requirements, e.g.: intact antibody analysis, peptide mapping, multiple post translational modification analysis, glycosylation patterns, disulfide bond mapping, oxidation, deamidation and sequence truncation, etc. Analytical characterization provides unique insights into the development potential of biopharmaceuticals.
Monoclonal antibodies (mAbs) are one of the fastest growing class of pharmaceutical products; these are considerably large, highly complex and heterogeneous glycoproteins with >20,000 atoms and molecular weight approximately 150 kDa. Post translational modifications on mAbs are critical in elucidating immune response and can significantly influence the overall efficacy and stability of the final product. Detection and quantification of these subtle modifications can be achieved with unprecedented accuracy by deploying high resolution MS either at intact protein level or separated light and heavy chains of the antibody, usually referred as Top-Down proteomics approach or by an alternate approach involving enzymatic digestion referred as Bottom-Up proteomics approach.
India’s opportunity from Biological Patent Expiration:
Twenty one biologics with a market value of about $54 billion will be losing patent protection by 2019 in the US. The bulk of global revenues for the Indian generic drugs come from the U.S. market, and now a similar opportunity knocks the Indian pharma doors in the form of biosimilars to enter a global level competition; market revenue is estimated about $3,987 million by 2017. From 2012 to 2017, global pharmaceutical sales are expected to rise 13% in the “pharmerging markets” compared to 2% for the top mature markets, according to the IMS Institute for Healthcare Informatics. Below table summarizes the developmental stages of biosimilars pipeline from leading biopharma companies in India, starting from preclinical to clinical segments.
State-Of-the-Art Analytical Services:
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmadabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA. Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our comprehensive services are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified and experienced industry leaders, we apply innovative technologies, therapeutic expertise and a commitment to quality in order to help clients develop products safely, effectively and quickly. As a total drug development solutions provider, Lambda offers globally compliant services through a competent force of human skills and advanced infrastructure.
Lambda’s trajectory is aimed towards becoming a major market player for providing in-depth analytical services to foster the biosimilar programme. We envision becoming a one stop solution provider for complete biosimilarity assessments. Our state-of-the-art technologies include advanced LC coupled mass spectrometry platform.
A diverse range of advanced analytical technologies including 6500 QqQ MS, CE-MS PA 8000+ , Q-TOF MS, MALDI-Iontrap-TOF, 2D-LC, Bioanalyzer are currently deployed and several PK based methods have been established for our clients.