About us

Determined to
set the gold standard

17 years of experience in recombinant biopharmaceuticals has given us an in-depth understanding of the expertise, instrumentation and capabilities required for biopharmaceuticals characterization.

Our cutting-edge analytical facility houses all key instrumentation required for biologics characterization and bioanalytics in an ICH compliant, fully auditable and high quality system/infrastructure.

We have a highly experienced team of 35 members , mostly comprising Ph.Ds and masters qualifications to carry out the analyses with all the necessary global compliances.

Our in-house Analytical Development Team, Cell Biology and Bioassay Development Team, Quality Assurance Team, Clinical Research, Regulatory, Legal and IPR teams enable us to offer end-to-end solutions.

This enables us offer unique solutions to various biotech companies:

Small and medium biotech companies requiring a complete auditable, and compliant product characterization dossier at every regulatory submission.

Biotech companies engaged in clinical studies that require bioanalytical studies.

Biotech companies which are engaged in phase III or post marketing surveillance that often require bioanalysis and immunogenicity studies.

Biotech companies engaged in development of biosimilar products requiring to establish biosimilarity with the innovator product involving head-to-head, simultaneously-carried-out comparisons.


Expertise

Management Teams:

Sanjay Sonar,

PhD

Dr. Sanjay Sonar has core expertise and experience in protein engineering for the last 26 years. His general expertise lies downstream process development for prokaryotic and eukaryotic expression systems, DOE based process and characterisation analytics development, protein functional characterisation using ultrafast spectroscopy. He has several years’ experience in chemical modifications of proteins using small molecules and pegylations, and developing advanced protein engineering technologies such as site specific non-native amino acid incorporations into proteins using amber suppressor tRNA technology. His specific expertise lies in characterisation of protein based biopharmaceuticals using biochemical, spectroscopic, chromatographic, mass spectral techniques. His experience also includes characterisation of process induced heterogeneities in biopharmaceuticals, immunogenic impurities and their impacts in clinical outcomes. He contributes in regulatory requirements in various aspects of analytical methods developments, validations and dossier preparations.Dr. Sonar is a Ph.D. from the Indian Institute of Technology (IIT) Powai, and has carried out 6 years of Post-doctoral work with Dr. Kenneth Rothschild, Boston University. He has worked in a close collaboration with Prof. Har Gobind Khorana, Nobel Laureate at Massachusetts Institute of Technology (MIT), Cambridge, USA. Dr. Sonar has over 25 publications in journals such as Nature and Proc. Natl. Acad. Sci., and also holds more than 50 patents.

Archana Krishnan

PhD

Dr. Archana Krishnan’s expertise lies in Molecular Biology, Cell Line Development, Protein Expression and Fermentation. She has several year's of experience in MCB- WCB characterizations, DOE based media optimisations for mammalian cell culture systems, spent media analysis, mammalian cell line characterization, determining sites of gene integrations, gene copy numbers and related transcriptomics.She has completed her Ph.D. in the field of Genetic and Protein Engineering. For her Masters degree, she holds the gold-medal. Dr. Krishnan has several national and international publications and over 15 patents to her credit.She is experienced in development for PCR and real time PCR based assays for clinical diagnostics and for biologics’ manufacturing and related process characterization. She has developed several PCR and quantitative PCR based viral assays for bioprocess characteriztion. Her specific expertise also lies in development of assays using the Next Gen sequencer and FISH based assays for cell line characterization She has several years experience in development of assays for biologics PK studies using immunoassays, antibody based kit development unique to a bioprocess, customisation of HCP assays and development of antibodies and assays for immuogenicity.She has completed her Ph.D. in the field of Genetic and Protein Engineering. For her Masters degree, she holds the gold-medal. Dr. Krishnan has several national and international publications and over 15 patents to her credit.

Abhishek Deshpande

(Finance and Business Administration)

Abhishek is Chief Financial officer and a core member of the management team since the firm’s inception. He has over 12 years of national and international experience. Over the last few years, he has developed core expertise in Management of Finances, Accounting and Admintistration of Biopharmacuetical Research and Manufacturing.

Specific Teams :

Analytical Development Team (ADL)

Our in-house Analytical Development Team is well versed in understanding peptides & proteins along with CQA and regulatory requirement of biosimilarity. The ADL team is expert in method development, product characterization and methods validation in support of early stage programs in biopharmaceutical production. The Analytical Development group forms an integral part of the services we offer, ensuring that all process parameters affecting product quality are identified and fully understood. This enables the successful operation of Quality by Design in routine cGMP manufacture This team comprises of 17 members mostly with either Ph.D or Masters qualifications.

Cell Biology and Bioassay development Team:

The forte’ of the Cell Biology team, with its vast technical experience is product characterization in terms of the biological actions at the macromolecular level, using the relevant models. The scope of work encompasses the entire product development cycle, from product characterization to pharmacokinetics, pharmacodynamics and immunogenicity; and is guided by strict regulatory compliance. The Cell Biology team serves as a critical arm of the services we offer, ensuring that the product profile is completely understood in the context of the relevant physiology(ies). It caters to the entire product development cycle, through the wide array of physicochemical and biological tests to establish biosimilarity. The Cell-Biology and Bioassay team comprises of 8 members with either Ph.D. or Masters qualifications.

Quality Assurance Team:

A dedicated Quality assurance team ensures customer satisfaction through delivery of consistent and reliable service, products, technology and data based on mutually agreed milestones, meeting the requisite set quality standards. The QA team comprises of 5 experienced members.

Clinical Research, Regulatory, Legal and IPR team

Experienced in clinical trials handling of development of New Chemical Entity (NCE) and New Biological Entity (NBE) from inception to final clinical trial report filing. The team has experience in Biosimilar product development programs as per global regulatory norms for Phase I & III. The Regulatory team has handled dossiers of several countries and have filed several Patents in global environment.