Research remains the strongest pillar in our journey towards providing high-quality and affordable medication. BSV is one of the earliest manufacturers of gonadotropin biosimilars (fertility hormones such as FSH, LH, HCG) in India.

The process for biosimilar medicine development involves a stringent development procedure, starting with the structure and functional aspects of the reference medical product, through advanced analytical technologies. Once the desired quality attribute profile is established, our scientists are involved in quality clone selection from thousands of cells. The optimal clone that produces the therapeutic protein of interest, matches the biological function of the reference product as closely as possible, thereby demonstrating that there are no clinically meaningful differences between the reference product and the biosimilar based on the findings from all of these studies.

We were the first Indian company to introduce the biosimilar version of the recombinant FSH in 2008. Keeping up with the advances in the medical field, we’ve introduced various strengths and sophisticated presentations, like multidose pen injections. BSV has also launched the recombinant biosimilar of chorionic gonadotropin in India & ROW markets.

We have expanded the gonadotropin biosimilar portfolio along with monoclonal antibodies. With our team of experts, BSV introduced a novel Biologic monoclonal antibody in 2021. This product is used to prevent Rh isoimmunization in pregnant women.

The Cell Line Development (CLD) Laboratory is a specialized facility dedicated to the development of stable and high-performing mammalian cell lines for biopharmaceutical applications. The laboratory is designed to support the complete cell line development workflow, encompassing vector construction, cell transfection, single-cell cloning, clone screening and selection and research cell banking.

The facility plays a critical role in the development of robust production cell lines for the manufacture of monoclonal antibodies, recombinant proteins, and other complex biologic therapeutics. Through systematic evaluation and optimization, the laboratory enables the identification and selection of cell lines exhibiting high productivity, desirable product quality attributes, and long-term genetic stability. The facility operates in alignment with industry best practices and regulatory expectations, ensuring the generation of well-characterized, scalable, and manufacturing-ready cell lines that serve as a strong foundation for successful bioprocess development and commercialization.

The Upstream Process Development (USP) Laboratory at BSV is a state-of-the-art facility focused on the development, optimization, and scale-up of mammalian cell culture-based bioprocesses. The laboratory supports the entire product development lifecycle, from early-stage cell line and clone evaluation through process development, process characterization, technology transfer, and manufacturing readiness activities. Its capabilities facilitate seamless progression from proof-of-concept studies to commercial manufacturing support.

The laboratory infrastructure comprises dedicated areas for cell banking and cell maintenance, media preparation, inoculum development, and bioreactor operations. Designed in accordance with industry best practices, the facility adheres to stringent standards for biosafety, quality, and operational excellence, ensuring a highly controlled environment for bioprocess development and evaluation. The USP laboratory enables systematic execution of a broad range of upstream development activities, including Cell line evaluation and characterization, Cell banking and stability studies, Media and feed optimization, Batch, fed-batch, and perfusion process development, Process parameter screening through Design of Experiments (DoE), Process intensification strategies, Scale-up and scale-down model development, Process characterization studies, Technology transfer and manufacturing support.

To establish Upstream activities, the facility is equipped with a comprehensive suite of development platforms, ranging from shake flasks and spinner flasks to advanced high-throughput and bench-scale bioreactor systems. These include the Ambr® 250 parallel bioreactor platform for rapid process screening, as well as 2 L, 5 L, and 10 L stirred-tank bioreactors for process development and scale-up studies. The laboratory is further supported by modern analytical and cell culture infrastructure, including multiple Class II Biosafety Cabinets, CO₂ incubators, metabolite analyzers, microscopes, and other essential equipment required for efficient process development and optimization.

BSV possesses extensive expertise in developing robust and scalable upstream manufacturing processes for a diverse portfolio of biopharmaceutical products, including monoclonal antibodies, heavily glycosylated gonadotropin hormones, recombinant therapeutic proteins, and other complex biologics. This experience enables the organization to deliver efficient, high-quality, and commercially viable bioprocess solutions across a wide range of therapeutic modalities.

At the heart of every successful biologic is a purification process that delivers uncompromising quality. Our approach integrates cutting-edge chromatography systems, advanced resins, and robust process controls to ensure reproducibility from lab-scale development to full-scale manufacturing.

Beyond mAbs, BSV excels in expediting the process development for the complex molecules like therapeutic gonadotropin hormones. These highly complex proteins poses challenges due to their intricate post-translational modifications. Our scientific team creates specialized purification processes that preserve key isoform profiles, ensuring rapid, cost-effective transition from lab to commercial production with the highest quality standards.

Transforming Biologics into Safe, Stable Therapies: At BSV, our Drug Product Development capabilities bridge the gap between upstream discovery and real-world therapeutic application. We do comprehensive formulation development for a broad range of biological modalities. Whether optimizing a liquid formulation for a monoclonal antibody or developing a multiple presentations and SKUs like liquid, lyophilized, vial, PFS or Pen cartridge for complex gonadotropin hormones. Our team focuses on maintaining quality and safety during shelf life and offering convenience to the patients. By addressing stability and scale-up challenges early in development, BSV ensures a rapid, predictable path to commercial-ready drug products.

Advanced Analytical development: Understanding that, orthogonal analytics are essentially the foundation of any biotherapeutic development program, BSV has established state-of-the-art analytical infrastructure. Our analytical development equips a combination advanced technologies with highly sophisticated applications like Mass Spectrometry (LC-MS, LC-MS/MS), advanced Chromatographic (HPLC/UPLC ) and Electrophoretic (CE) systems amongst others. These applications enable comprehensive analysis of different aspects of the protein structure, product variants, impurities, post translational modifications particularly like highly complex glycosylation.

With an elaborate experience on phase-wise analysis for complex proteins, the capability is enabled to facilitate multivariate development support throughout the product lifecycle.

Functional characterization (Cell Biology Lab): A critical parameter of any biomolecule is its functionality and cell based assays play an indispensable role in establishing the functional role of the molecule. 

The functional characterization (cell biology) lab of BSV R&D Biotech is involved in developing various in vitro cell based assay methods to determine functionality, potency and mechanism of action (MoA) of the molecules. These assays are developed using multiple readout modes such as absorbance, luminescence, chemiluminescence and FACS based methods. The various MoA based assays include, but is not limited to, signal transduction due to receptor binding, ADCP, ADCC.

Additionally, the lab also collaborates with partners for in vivo bioassay and monitors the scientific aspect of preclinical studies. The lab is also involved in carrying out various other ELISA based methods for protein titer estimation and impurity analysis as well as qualitative characteristics of proteins using SDS PAGE and western blot-based methods.